Chronic Lymphocytic Leukemia Archives

Chronic lymphocytic leukemia (CLL) is a typically slow-growing cancer which begins in lymphocytes in the bone marrow and extends into the blood. It can also spread to lymph nodes and organs such as the liver and spleen.

CLL develops when too many abnormal lymphocytes grow, crowding out normal blood cells and making it difficult for the body to fight infection.

More resources for Chronic Lymphocytic Leukemia (CLL)  from Patient Empowerment Network.

The Importance of Self-Advocacy

Interview of V.K. Gadi, MD, PhD Associate Member, Clinical Research Division, Fred Hutchinson Cancer Research Center

Dr. Gadi is interviewed on the importance of self-advocacy by cancer patients. He explains that historically, the doctor/patient relationship has been paternalistic, but such is not the case anymore. Now, Dr. Gadi learns just as much from his patients as from other sources. When patients are empowered with knowledge about their disease, they will be better equipped to carry on an intelligent conversation with their medical team and better understand the rationale for their treatment plan.

Dr. Gadi encourages patients to learn and to self-advocate in order to better understand their treatment options and help choose the best care available to them.

The Importance of Patient Self-Advocacy from Patient Empowerment Network on Vimeo.

Questions Patients Have About Clinical Trials

Interview of Dr. Philip Thompson, Assistant Professor, Leukemia Department, MD Anderson Cancer Center

Dr. Philip Thompson, MD, Assistant Professor, Leukemia Department, Anderson Cancer Center is an oncologist and a researcher who runs many of the clinical trials at MD Anderson. Dr. Thompson is interviewed by CLL patient, Carol Preston about some of the many questions patients have concerning clinical trials.

Dr. Thompson discusses informed consent and the lengthy paperwork involved. He explains that the informed consent document usually covers legal requirements of all stakeholders in the trial and is therefore often difficult for patients to understand. At MD Anderson, there are nurses and other healthcare personnel who can help a patient through this process.

Dr. Thompson advises patients to ask questions of their medical team. An important question to ask at the outset is  what are the benefits and risks of the trial versus the benefits and risks of the standard treatment of care.

Logistics is also an obstacle for many patients. Early phase studies require a great deal of office visits and testing which, in turn, means a great deal of travel to and from the hospital. If the patient lives far away, this could be a hardship. Again, patients need to ask questions and make decisions about what is the best option for them.

Cost is an issue for many patients. Trials require more testing that their insurance may not cover. As a guiding principle, there are 2 types of tests in a trial: those that are considered specific to the study (these are covered by the trial sponsor) and those that are considered standard of care (these are billed to insurance). But there are gray areas. For instance, the study may mandate a CT scan every month and the insurance company may not consider that to be standard of care and not want to pay. Again, patients have to ask questions and demand answers to those questions so that they can make the best decision for them.

Bottom line is: Ask, Ask, Ask!!! Ask questions of your medical team and if you don’t understand the answer, Ask Again!

Questions Patients Have About Clinical Trials from Patient Empowerment Network on Vimeo.

After Failed Chemotherapy, A Clinical Trial Gives Hope

Interview With Cancer Patient, Lisa Weiss

Lisa Weiss, a 3x cancer survivor, has an aggressive form of chronic lymphocytic leukemia. Lisa underwent chemotherapy for her CLL, but she was not responsive. She and her doctor researched clinical trials and found a trial that was just opening.

Carol Preston, a CLL patient herself, interviews Lisa about her experience with her disease, how she searches for information and her relationship with her medical team.

Lisa explains that she has been dealing with her disease for quite a while. She founded a support group on Facebook (CLL, SLL, NHL Cancer Support for Women) and helps new patients navigate their journey. It is the new patients who have so many questions and who are quite overwhelmed that Lisa tries to help. She keeps her group posts understandable and less technical so that newer patients can learn about their disease and easily take questions to their doctor.

Lisa says that her doctors listen to her because they know her and know her history and know that she wants to take part in her treatment. Lisa’s doctors know what her goals are and what she wants to achieve. She adds that once a patient has confidence and understands about their illness, the conversations are pretty easy.

Lisa concludes by advising patients to learn as much as they can. Once you understand the risk/benefit, you can make decisions more easily.

After Failed Chemotherapy, a Clinical Trial Gives Hope from Patient Empowerment Network on Vimeo.

Can Digital Wearables Help in Clinical Trials?

Today’s healthcare consumer can log and produce a range of data through wearable devices, smart fabrics, and intelligent sensors that are worn on the body or incorporated into garments and accessories, such as wristbands and watches. To date, wearables have been limited to tracking information related to health and fitness, but as the technology behind wearables for healthcare evolves, there is a growing interest in its potential in medical settings. New wearables show promise for addressing a range of medical conditions from diabetes to dementia. When applied to clinical trials, wearable technology is a potentially powerful research tool to gather clinical data in real-time and provide remote patient monitoring.

digital wearables

photo from http://www.alivecor.com/home

The clinical trials process could be optimized by leveraging existing smart technology, such as electrocardiogram (ECG) monitors like AliveCor, which enables anytime recording of ECGs; and smart pill technology (also known as “ingestibles”) which allows for both wireless patient monitoring and diagnostic imaging. Digital health company Proteus Digital has developed FDA approved wearable and ingestible sensors that work together to detect ingestions and physiologic data. The sensor is taken alongside medications, and is powered by the body’s biochemistry. The patch, body-worn and disposable, receives the data from the ingestible sensor, tracking medication-taking, steps, activity, rest, and heart rate and forwards that information to a Bluetooth enabled mobile device. If life science companies can get enough insight early in development, they can potentially create a more efficient drug development process and prioritize resources for the most promising therapies, with the goal of getting effective drugs to market faster.

Clinical use adoption will depend on ease of use, relevance and accuracy. Google’s life sciences division at Google X is in the process of developing a wearable health sensor specifically for use in clinical trials. The developers, who have already created a glucose-sensing contact lens, want to see how a continuous stream of medical-grade measurements of biological signals could be used to help earlier diagnosis or intervention in disease. The prototype wrist-worn sensor measures pulse, activity level, and skin temperature, alongside environmental information like light exposure and noise levels. Right now, it isn’t clear how Google’s prototype device will collect, analyse, and interpret data and incorporate information into a clinical trial data feed.  Issues of data standards and security will also need to be worked through. Google is in the early stages of the project, which will work with academic researchers and drug makers to test the wristband’s accuracy and seek regulatory clearance in the U.S. and Europe. The project will also draw on Google’s ongoing Baseline study, a medical and genomics project involving Stanford University and Duke University, which aims to map a healthy human body. Google Baseline will use a combination of genetic testing and digital health sensors to collect “baseline” data on healthy people. The project aims to establish genetic biomarkers relating to how we metabolize food, nutrients and drugs, how fast our hearts beat under stress, and how chemical reactions change the behavior of our genes.

Google’s wearable prototype, and other similar existing wearable devices, could give researchers insights that are currently only available intermittently (e.g. via a diagnostic test, or when a patient is being observed in a clinical setting).   Using sensors and wearables, drug efficacy and clinical trials outcomes might be better assessed through a variety of data points. It also allows for more objective measurement of data. For instance, obtaining objective metrics of hours of sleep in a clinical trial can be difficult to measure in a traditional trial setting when patients record this information at home. Being able to measure hours of sleep objectively through a wearable device could provide more complete data, although researchers still need to consider the context within which all data is captured. Having structured analysis of supplementary data may provide the additional evidence needed to show the benefits of a certain drug. However, more data does not necessarily translate into better data. The use of a wearable device alone does not add value to the clinical trial process. The real value lies in the ability to extract raw data and leverage real-time analytics to monitor trial progress in the moment, thereby facilitating early intervention which may reduce trial risks. In addition, continuous tracking of vital signs outside of a laboratory provides patients with better support through remote patient monitoring. Wearable technology’s transformative potential therefore lies not with the wearable itself, but with the real-time response to the data it collects.

As the healthcare ecosystem continues to shift to patient-centered care, a key consideration in designing the clinical trial of the future is the ability to make the process highly responsive and seamlessly connected to the patient’s every-day life. Currently the clinical trials process is inconvenient for participants; both in terms of time spent travelling to and from the trial location, and the time required to log physiological and drug reactions. Wearable devices can reduce the number of times patients need to go to a clinic and can provide a better, fuller picture of physiological data needed to measure a drug’s impact. Medidata and Garmin are collaborating to use Garmin’s activity tracker —the vivofit — in clinical studies. The vivofit measures steps taken, calories burned, and hours slept to capture patient data during clinical trials 24/7, without the need for clinic visits. The clinical trial data it collects is integrated with the Medidata Clinical Cloud repository that includes information such as vitals, medical histories, laboratories, and adverse events. Used in this way, wearables not only lead to increased data, but through remote monitoring, can reduce interruptions in a volunteer’s day.

Clinical trials are often criticized for not being sufficiently patient-centric. Innovating through the use of wearable devices can address this challenge by streamlining the process and creating greater patient engagement. The Clinical Innovation team at Eli Lilly recently offered a glimpse into the future through an interactive and immersive clinical trial simulation for Stanford Medicine X conference attendees. The team highlighted design considerations for remote clinical trials, as well as working prototypes for a mobile patient trial app, provider trial app, and a medical-grade biosensor. In order to contextualize and make data actionable, the design team at Eli Lilly is working on a closed-loop system that triggers an alert when certain metric points are activated, thereby allowing for real-time adjustments to be made.

Making the clinical trial process more convenient and connected through wearable devices could potentially explode the sample size of clinical studies, not just numerically, but also in terms of diversity – gender, ethnic, geographic, economic. We might then begin to get a more stratified picture of individual variation; hard to do with current methods of traditional clinical studies. The large uptake of Apple’s ResearchKit (an open source software framework for app development) on its release earlier this year, signals a greater willingness to take part in research when tools are designed to make participation easier. Within a day of ResearchKit’s launch, 11,000 volunteers signed up for a Stanford University cardiovascular trial; an unprecedented uptake. At the time, Stanford said it would normally take a national year-long effort to get that kind of scale.  However impressive these numbers are, a large test sample only matters if there are enough quality results. Furthermore, diversity is compromised if lower socioeconomic populations are excluded through restricting sampling to people that are iPhone users. If the very people who tend to be most affected by chronic diseases are excluded, research will be skewed toward a demographic that is markedly different than the one typically affected by the target disease. Still the future looks hopeful. With any study, there are challenges around how representative the study cohort is. The expectation is that smartphone apps, wearable devices, and biosensors can make the clinical trials process more responsive to volunteers, expand recruitment, and make the data source richer.

Challenges and Opportunities

The clinical trial of the future will increasingly take place outside the walls of the clinic. Tailored to the patient’s lifestyle, wearables can lead to increased patient engagement and ultimately bigger and smarter data. Trial volunteers will wear a device that continuously measures their activity and provides a complete picture of movement without having to disrupt their day. Physicians and researchers will have access to a much richer, more objective data set, thereby providing a real-world, real-time measure of patient physiology and how a drug affects quality of life. This will allow us to have a more holistic view of the patient than we have ever had before.

Wearables are emerging as a tool for creating a more responsive and efficient clinical trial process. At the same time, wearable devices can increase the volume and speed of data collection through a more seamless collection of large quantities of longitudinal physiological measurement data. This approach to clinical trial management promises to significantly change how trials are conducted and increase the value of trial data. However, the challenge lies in how to unlock the data’s value to make it more actionable, contextualized and meaningful. How will researchers turn the sheer volume of data they collect into quantifiable safety and efficacy measures and endpoints? At this point wearables don’t yet offer the type of medical or diagnostic-quality data that’s necessary for most clinical trials. Researchers must ensure not just accuracy of data, but also be able to evaluate and identify the data pertinent to the clinical trial outcome. For instance, a sleep monitor on its own cannot contextualize the reason why people wake up – they may be having an asthmatic attack, or a bad dream, or simply need the bathroom, but the monitor registers each of these instances as the same event. Or take the scenario of a trial participant who transfers his/her activity tracker to someone else – what would happen to the validity of the data in this case? How can researchers handle patient device use and adherence variability?

Stakeholders must work together to determine how to best deploy wearable devices to patients, define standard use, mitigate variability of use, link the data from these devices to traditional clinical data, account for data collection in a non-controlled environment, and maintain privacy and data security. With much work still to be done to scientifically evaluate the real impact of wearables on clinical trial data, regulatory compliance in collecting clinical data outside of a controlled research environment is an on-going challenge. Wearables offer an opportunity to disrupt the clinical trial process, leading to a radical redesign of patient-centered clinical trials.  For now, we must learn to balance the hype which surrounds wearable technology with the operational and design challenges posed by standardizing and controlling the data collected for use in clinical trials. Focusing on these challenges will help to ground wearable technology in the reality of what is achievable, while the industry takes its first steps on the path toward designing next-generation clinical trials through wearables, and ultimately new ground-breaking drugs and treatments.

Clinical Trials: Facts and Myths

Interview: Dr. Philip Thompson from MD Anderson Cancer Center

Carol Preston, a nine year cancer patient, interviews her oncologist, Dr. Philip Thompson, Assistant Professor, Leukemia Department at the MD Anderson Cancer Center. Dr. Thompson treats patients and also runs clinical trial studies searching for the next best treatment (and perhaps cure) for cancer patients.

Dr. Thompson explains what a clinical trial is, clinical trial phases, patient eligibility and what is involved in enrollment and participation.

Thompson explains about the use of placebos and the fact that they are very rarely used and are basically considered unethical for use in cancer trials. He goes on to explain that the patient’s interests are paramount in a trial. Patient participation is completely voluntary and the patient can withdraw from the trial at any time.

Thompson also explains that before the trial, the drug involved has been extensively tested in the laboratory for toxicity, side effects, and a number of other properties. Patients on the trial are extremely carefully monitored for any abnormal occurrence by a team of experts that study all laboratory tests and clinical findings.

When asked who should consider a clinical trial, Thompson answers, “In my opinion, everybody should consider a clinical trial so at least they have all the information available to them….There are always risks and unanticipated side effects, but what the study will always benefit is the population as a whole…. If you choose not to participate in a clinical trial, it will not in any way prejudice your care.”

Watch the video for the full interview:

Clinical Trials-Facts and Myths from Patient Empowerment Network on Vimeo.

An Oncologist’s Perspective on Clinical Trials

(Editor’s note: This article is in 2 parts. This is Part 1 (go here to read Part 2) and consists of an interview of Dr. Anita Wolfer, Senior Oncologist and Head of Unit in Oncological Research, Lausanne University Hospital (CHUV). The interview was conducted by the “Indomitable” Christine Bienvenu, breast cancer patient, avid patient advocate and board member of the Patient Empowerment Foundation, our sister organization under development in Europe. And please, don’t be concerned that this is an interview with a European oncologist. You will be surprised to see that the issues, thoughts, concerns of patients and doctors are the same. These issues are worldwide!)

Great progress has been made today in immunotherapy and targeted therapies – especially in cancer research – thanks to patients having access to clinical trials. It is crucial that patients learn about their options.

Interview With Dr. Anita Wolfer

The Indomitable Christine Bienvenu

The Indomitable Christine Bienvenu

Christine Bienvenu (CB): How do clinicians learn about clinical trials?

Dr. Anita Wolfer (AW): It depends very much on where they’re working: Doctors in university hospitals are constantly informed of clinical trials. Their peers outside the hospital environment are not, though: It’s up to them to actively find clinical trials and stay informed.

 

CB: Here in Switzerland, are there formal protocols in place for spreading information about clinical trials?

AW: In terms of the medical system, there aren’t any formal protocols on doctors being up to date on clinical trial options. I think it’s important that university doctors take it upon themselves to keep their non-university environment peers informed. Often, unfortunately, those oncologists working outside the hospital environment only think of clinical trials when conventional treatments have failed. For researchers like us, it’s more second nature to turn to them for treatment options.

Here in Switzerland, the “Réseau Romand d’Oncologie” (Western Switzerland’s oncology network) centralizes all the information about clinical trials, and keeps it updated. For the new Swiss Cancer Center Lausanne (SCCL) opening in 2017, its director, Prof. Coukos’ vision is simple: All information – clinical trials, research, collaboration, and participatory medicine – should be accessible to patients and professionals alike.

 

CB: When and why do clinicians talk about clinical trials to their patients, and how do you view the patient’s role in trials?

AW: Often today, oncologists will only talk to a patient about clinical trials if they see that there’s a direct benefit to the patient. But in my view, it’s important to inform the patient of the clinical trial, regardless so that they too can look into the application process. In an ideal world – and I say this as an oncologist and clinical researcher – there would be a clinical trial for every patient who walks through our doors.

As for the patient’s role, I’m a firm believer that sharing is building in this profession. Patients are crucial in this process: No-one knows their bodies better than they do. The way I see it, any patient of mine gives me the opportunity to learn. I don’t want to waste that.

 

CB: What obstacles do clinicians face in conveying clinical trial information to their patients?

AW: Unfortunately, some oncologists are afraid that university doctors might “steal” their patients, so they don’t readily refer them for fear of losing income for their own hospital. With patients being so closely followed during the clinical trials as well, this is comforting: Often, they’d rather not go back to their ‘regular’ oncologist. In my view, it’s a shame to look at it that way: If there’s a relationship of confidence and trust with their primary oncologist, if patients know they will get all the necessary information, they’ll be more inclined to stay with their respective ‘regular’ oncologists. To be brutally honest, my feeling is if an oncologist is upset about a patient seeking a second opinion, then maybe it’s time to find a new oncologist? It happens in the medical profession: I’m not immune to it – no-one is. But it shouldn’t be an issue… Just like in any relationship, if the doctor/patient relationship isn’t working out for the patient, he or she has every right to move on.

 

CB: In your profession, how important is mindset – in both the patient and the doctor or clinician?

As in any profession, or with any patient or co-worker, there are always those who are willing and excited to go the extra mile. If the mindset to do so isn’t there, there really isn’t much that either a patient or an oncologist can do in terms of moving forward. A pro-active mindset is crucial.

 

CB: In the same vein, how important is mindset in clinical trials, then?

AW: Being convinced about the clinical trial is also very important – not only for the patient, but for the doctor. A well-informed doctor means a well-informed patient. Speaking for myself, I’m constantly on the lookout for the best treatment options for my patients – even if it’s a clinical trial outside the CHUV. Why wouldn’t I? It’s about moving forward in cancer research, not about being territorial with knowledge.

 

CB: What role, for you, does the sharing of information and access to clinical trials play in patient mindsets?

AW: Armed with information, most patients are willing to be a part of trials – even if it isn’t one they had specifically hoped for. Time and again, we’ve seen how patients who participate in clinical trials usually have better outcomes than patients who don’t. Beyond the obvious rigorous monitoring, the crucial element here is that the patients feel more responsible for, and engaged in, their care. What strikes me, time and again, is that clinical trials offer hope. And while not every clinical trial story is a positive one – with frustration and heartbreak often integral to the process – hope is a crucial element and great motivator.

 

CB: Getting into clinical trials is no small feat. What improvements, if any, would you suggest? Can patients be better-informed about clinical trials?

AW: In an ideal world, there would be a clinical trial for every patient. One of the objectives of the CHUV oncology department is to have a portfolio of trials so that there are alternatives for every patient. And despite limited resources, the department is working hard to open up a maximum of number of trials. Also, with the SCCL opening up in Lausanne, more research funding is coming in, and more specialised oncologists are coming on board.

 

CB: What for you is a key component of a successful patient/clinician or doctor relationship?

AW: Ultimately, it’s about trust, confidence and collaboration. And going back to your previous question, if patients feel they’re being fully supported by their oncologist, they’ll return to them – university hospital setting or not. To me, it’s extremely important that patients take the necessary steps to establish the relationship of trust that they seek.

 

CB: What feedback have your patients given you about their experiences in clinical trials?

AW: Some patients will say outright that they’re not interested. But the vast majority – I’d say 70-80% – are willing participants. So far, I’ve only ever had one patient tell me she wasn’t happy with a clinical trial. For most, it goes beyond participating for their own benefit, per se: it’s about being part of a greater cause and helping medical science advance. Patients are genuinely altruistic. What is clear, though, is that it’s a team effort that involves the patient and the medical community.

 

CB: Where can patients find information about clinical trials?

AW: There are a number of great resources out there. In no particular order, I can suggest the Swiss Group for Clinical Cancer Research (http://sakk.ch/en/) or Clinical Trials (https://clinicaltrials.gov/) which is a service of the US National Institutes of Health that lists all the studies being done in all 50 US States and in 190 countries.

Here in Switzerland, there are obviously the Lausanne University Hospital (CHUV: http://www.chuv.ch/) or the Geneva University Hospital (HUG: http://www.hug-ge.ch/) websites. Experience has taught me that the university websites are sometimes a bit outdated, but patients can send emails directly to oncologists there and should get an answer.

 

CB: Any parting words of wisdom?

AW: Patients never doubt themselves in asking questions. There is no such thing as a stupid question. If a patient isn’t having his or her questions answered, he or she has every right to find someone who will! Questions are crucial: They lead to greater understanding, knowledge, and progress.

Also, it’s important to remember that in Clinical Trials, limits have to be set to be able to provide realistic results. Make the criteria too broad, and it becomes difficult to show a trial’s effectiveness. With immunotherapy, clinical trials broaden patient eligibility. Granted, a patient needs to be healthy enough to be able to benefit from a trial, so if for example a patient is in palliative care, they wouldn’t be eligible – unless, of course, the clinical trial is in palliative care.

The National Cancer Institute’s (NCI) “10 step guide on how to find a cancer treatment trial” helps patients better understand what clinical trials are all about, how to talk to their doctors, and know what questions to ask, visit: http://www.cancer.gov/about-cancer/treatment/clinical-trials/search/trial-guide?cid=tw_NCIMain_nci_Clinical+Trials_sf39211784

A Clinical Trial as a Positive Experience

During the fifth session of Patient Cafe™, Mike talks about his initial diagnosis and his feelings during that time. Mike had no symptoms of his disease and was on watch and wait. He felt fine but was concerned that his healthcare plan did not give him access to a CLL specialist. He switched plans in order to get a second opinion and ended up seeing Dr. Rosen from City of Hope who helped him enroll in a clinical trial.

Mike had a very positive experience during the clinical trial. He had almost no side effects and responded well to the treatment. When asked what he would tell other patients who were perhaps a bit afraid of enrolling in a trial, Mike answered that it is very easy to be afraid if you read about all the horrible side effects that are possible. But if you talk to the medical team and ask them what is most likely to happen, they will give you a pretty good idea.

Watch the video and listen to Mike relay his experience:

A Clinical Trial as a Positive Experience from Patient Empowerment Network on Vimeo.

Clinical Trials and Young Cancer Patients

Few Cancer Patients Enroll in Clinical Trials

It is well known that very few people with cancer actually enroll in clinical trials. This, for a myriad of reasons, including misconceptions, logistics, awareness, eligibility and fear.

Many patients lack awareness of what a clinical trial actually is, what it is for, and what is being tested.

Many healthcare professionals do not fully communicate information about clinical trial availability and participation when discussing treatment options with their patients.

Patient Advocacy organizations and other healthcare groups are trying to get the word out about clinical trials as a good treatment option and raise awareness. But progress is slow.

There are myths perpetuated about patients being “guinea pigs” in medical trials, or about patients being given “placebos” in the place of cancer medication. These myths need to be addressed and there are organizations and websites that do offer general answers to patient questions about trials. Patient Empowerment Network offers a FAQ page that addresses common questions about clinical trials. And ProjectInnovation offers a special section in their resource guide called, Debunking Common Myths About Cancer Clinical Trials.

Besides a lack of awareness and perceived misconceptions about clinical trials, there are logistics and eligibility obstacles that prove to be just too overwhelming for many patients. These obstacles are being addressed by many organizations, but again, progress is slow.

Do Younger Cancer Patients Experience the Same Preconceived Ideas About Trials?

Most cancer patients are older. What about the younger cancer patients? Do they feel the same way? Do they have the same misconceptions and the same fears? Do they also suffer from the same lack of awareness? Are they also overwhelmed by logistics and eligibility issues?

These are questions that StupidCancer and Bristol-Myers Squibb are trying to answer.

StupidCancer, founded by Matthew Zachary, is the largest charity that specifically focuses on young adult (age 15-39) cancer. There are 72,000 cases diagnosed each year of young adult cancer. This group suffers from a lack of awareness and understanding from the community around them. StupidCancer helps by building awareness, offering support and resources and generally getting the word out through advocacy, research, outreach, mobile health and social media.

Iamnotatrial Project

StupidCancer, in partnership with BMS, is embarking on a project called “iamnotatrial” that will feature young people between the ages of 15 and 44 years old who have completed a clinical trial in one or more of 15 cancer types. These clinical trial participants will be featured in a series of short videos that will tell their stories and relay their experience with clinical trials and will hopefully help build awareness and interest in clinical trials within the younger patient community.

When interviewed, a representative from StupidCancer explained that the goal of the iamnotatrial project is that by showing real patients and survivors telling their story in their own way, by video, that they can channel the energy of these patients and send it towards other patients who are taking action and looking for trials, enrolling and asking questions.

It is the hope and intention that viewers of the videos will become more aware that trials are a viable option, that there is diversity (gender and ethnicity) in trials and that there are many reasons to participate in trials- to help yourself as well as to help others.

Patients Helping Patients

Cancer Patient

Empowered Patient at a recent Town Meeting for Cancer Patients

Patients learn from patients like them. Patient stories are a powerful way of getting the message across. We are anxious to see these videos and champion their cause. We are anxious to help SupidCancer get the word out about clinical trials to their younger cancer audience.

Talk to your medical team and consider a clinical trial. It could be the best treatment option for you.

How Do I Enroll in a Clinical Trial?

Oftentimes when we hear the word “cancer,” we hear nothing else. Our brains stop processing information. We think we’re going to die, that there is little or no time to weigh options and/or get our affairs in order.

Fortunately, that last part the vast majority of the time isn’t true. We DON’T have to rush into anything. We DO have time to weigh our treatment options. And for many patients, those options can include enrolling in a clinical trial.

What is a clinical trial?

According to PAF, the Patient Advocacy Foundation, clinical trials are research studies in which we patients can help doctors find ways to improve cancer care.

There are several types of trials

  • Treatment: to test a new drug or approach to surgery
  • Prevention: to test new approaches with medicine, vitamins, minerals to help lower the risk of developing certain cancers
  • Screening: Best ways to detect cancer early
  • Quality of Life: Explore ways to comfort, quality of life for patients

Why participate in a clinical trial?

Through clinical trials, doctors and researchers find better ways to prevent, diagnose and treat cancer. Patients can benefit by receiving cutting-edge care or emerging medications. Rarely are placebos, or fake medications, used in clinical trials. Patients for the most part are being given the current standard of care or the new treatment, to determine the following:

  • Phase   I: Is the new treatment safe?
  • Phase II: Does the new treatment work?
  • Phase III: Does the new treatment work better than the current one?

Is a clinical trial right for me?

There are risks and benefits. A good place to start making an assessment is with your physician. Often, we’ll hear about a clinical trial from our doctor. However, you don’t have to have your doc’s OK to enroll in a trial, and it’s key to determine which trial is right for you.

While there is no one source to learn about all cancer clinical trials, you can break it down into clinical trial lists and matching services.

Lists:

The National Cancer Institute (NCI): 1-800-4-CANCER (422-6237 NCI sponsors most government-funded trials. You can search by the type and stage of cancer, by the type of study (treatment or prevention) or by zip code.

The National Institutes of Health (NIH):   NIH database is larger than NCI but not all trials are cancer studies

CenterWatchCenterWatch provides a list both of industry-sponsored and government-funded clinical trials for cancer and other diseases.

Private companies: Pharma or biotech companies may list studies they are sponsoring, either on their websites or through a toll-free number. You can search a company with the words ‘clinical trials’ in the search. If that company is conducting trials, it will appear in your search. For example:

pfizer.com/research/clinical_trials

amgentrials.com

abbviephase1.com

You get the idea.

As for those clinical trial matching services, each one works differently. Some may charge a fee to the trial sponsor. It could impact the way studies are ranked or presented to you. We suggest you start with the free sites. Sources include:

The American Cancer Society Clinical Trials Matching Service:    1-800-303-5691  ASC works with a company called Eviti  to connect patients with trials. It’s free. It’s confidential. It’s reliable. The lists are updated daily, and it allows patients to contact health care providers running the studies. The website also explains how to determine if you are eligible for a trial, if a trial is right for you.

EmergingMed:  1-877—601-8601  Also free, confidential and reliable for cancer patients seeking a trial.

Various organizations have partnered with EmergingMed and offer widgets that link to the EmergingMed trial finder. For instance, both the sites below link the viewer to the EmergingMed clinical trial finder:

www.oncolink.org/treatment/trials.cfm

www.lungcanceralliance.org

There is a wealth of information here. But you don’t have to become a Medical Doctor to digest and evaluate it. Start with your physician. If he or she doesn’t have enough information, choose a website or two on this list to navigate for information about trials. That’s what I’ll be doing should the day come that I need additional treatment. We are our best advocates about what’s right for us and when.

(We want to help you if you are considering a clinical trial. Please look at our FAQ and Clinical Trial Toolkit pages and browse our Patients Helping Patients blog for articles on clinical trials)

Clinical Trials

 

Clinical Trials 2.0: Reinventing Research For The Social Age

Clinical research is changing. No longer the sole preserve of clinicians and researchers, the Internet and new digital technologies are reinventing the way in which patients take part in the clinical trials process.

In the past decade there has been a revolution in how patients access health information. The Internet is increasingly the first port of call on our health-seeking journey. According to Pew Research Center’s Internet and American Life data, one in three U.S. adults have gone online to figure out a medical condition; 34% of Internet users have read someone else’s commentary or experience about health or medical issues on an online news group, website, or blog; and 18% of Internet users have gone online to find others who might have health concerns similar to theirs.

“Clinical research” is among the most-searched terms on the Internet; yet every year hundreds of trials are delayed or abandoned because they can’t recruit enough patients. Poor rates of trial recruitment are a major obstacle to the successful and efficient completion of clinical trials. Insufficient recruitment of study participants may result in losing the statistical power of a predictive conclusion, as well as prolonging the time it takes to get the trial drug to market. Oncology trials in particular are failing to meet enrollment goals, with most delays in conducting trials stemming from recruitment. 85 percent of cancer patients don’t know trials are an option. 55 percent of clinical oncology sites fail to get a single patient because they simply can’t find them and one third of trials fail to recruit a single patient1.

Given that enrollment into a clinical trial is frequently the best treatment option for patients with cancer, how might we make more patients aware of the benefits of clinical trials? Combining the power of new technologies with social networking and patient activation is our best chance at galvanizing the process of patient recruitment, and perhaps even an opportunity for us to completely reinvent the process of clinical research itself.

The world-wide web has opened a window to the world of clinical research. With the click of a mouse, we can now access information on the latest trials, download medical information to our portable devices, connect with researchers in real-time, and find other patients with the same condition. Dedicated websites such as the U.S government’s ClinicalTrials.gov site, and the World Health Organization’s International Clinical Trials Registry Platform (ICTRP), help patients easily find information on clinical trials. The launch of these sites represented a paradigm shift in clinical research; information that had once been closely guarded is now available to all. Some other note-worthy websites include The Center for Information and Study on Clinical Research Participation (CISCRP), a nonprofit organization dedicated to educating and informing the public about clinical research; and clinical trial recruitment sites, such as ClinicalConnection, TrialReach, EmergingMed and CureLauncher which exist to match eligible patients to appropriate trials. A new digital platform Cure Forward uses a patient’s uploaded genetic sequencing to connect cancer patients to clinical trials. The site, which is currently in beta, also offers cancer patients more information on the mutations and treatments available in “gene stories” specific to their genome.

Mobile applications can be downloaded from the Apple and Google Play Stores to give patients real-time access to current information about cancer clinical trials. This is opening up opportunities for better medical treatment and care, and allows those in regional and remote areas equal access to clinical trial information.  Some sites, such as the Novartis Clinical Trials website provide users with an interactive tool for finding relevant trials taking place near their location. A GPS search function allows users to see all the trials taking place in their country by location. For those looking further afield, the Novartis site features a global search function that displays clinical trials taking place in any country.

Popular social networking sites such as Twitter, Facebook, and YouTube are being used, alongside dedicated social media patient communities, to raise awareness and encourage wider participation in clinical research. The TrialX site encourages patients to send a tweet to @trialX, preceeded by “CT” describing the type of clinical trials they are seeking. Dr. Susan Love Research Foundation’s Army of Women Program (AOW) taps into the power of its social networks to mobilize research into the causes of breast cancer.

 

“The word Army, which means a large group of people united for a specific purpose, quickly and clearly describes who we are. The image of us all joining in a virtual Army to get this done is a powerful one” – Dr. Susan Love Research Foundation.

 

 

The traditional methods of advertising clinical trials through print media, brochures or poster displays, meant geographic limitations narrowed the pool of potential recruits. Using popular social networking sites, researchers can now accelerate the recruitment process by extending their social reach to take in a global pool of potential recruits. According to US hospital group, Mayo Clinic, social media is especially effective at recruiting patients for its studies into rare diseases. Social media and online networks could help researchers assemble large and demographically diverse patient groups more quickly and inexpensively than traditional outreach methods. “Patients with rare diseases tend to find one another and connect because they are searching for information and support,” says Mayo Clinic’s Marysia Tweet, M.D. “Studies of rare diseases often are underfunded, and people with these conditions are quite motivated.”

One such motivated patient is Katherine Leon, an SCAD (spontaneous coronary artery dissection) survivor, who was determined to find the cause of her disease, and prevent it from happening to others. At the time of her diagnosis, SCAD, a traumatic cardiac event that affects fewer than 200,000 Americans, was a poorly understood and under-researched condition. Physicians had no clinical studies on which to base treatment plans. Leon connected with fellow SCAD survivors through social media and used their collective voice to launch research at the Mayo Clinic. The study recruited 18 participants in less than a week, six more than could participate in the initial study of 12 patients. This rapid enrollment of participants through social networking served as proof of concept for future research studies to harness the power of highly-motivated patient communities. Leon credits social media as a key research accelerant. “Social media absolutely gets the credit for making scientific study of SCAD possible” she says. “In 2003, my cardiologist told me I would never meet another SCAD patient. It was just too rare. Today, I “know” more than 1,000 fellow survivors thanks to Inspire, Facebook ‎and Google. These patients are connected to the clinical trials immediately — at hello!”

Harnessing this dynamic combination of new digital and mobile platforms, social media, and activated patients offers an unprecedented opportunity for patients and researchers to find each other with greater speed and precision, which in turn can speed up the process of recruitment to clinical trials.

Peer-To-Peer Education

The ability to engage interactively through social media further enhances the benefits to patients. Reading information in a brochure doesn’t compare to the ability to interact and ask questions in a social networking site. What is it really like to take part in a clinical trial? Would you need to travel? Will it incur any personal expenses? What kind of side-effects might you have? Trial sponsors can respond in real-time to these questions, thus speeding up the recruitment process. In addition, patients already enrolled on the trial, can provide personal insight into what is involved. One patient, who has participated in two Phase 1 clinical trials, said that he was motivated to sign up for them, by reading others’ stories online. Hearing about the experiences of others who had participated and “come out the other side” encouraged him to take part.

Sometimes there can be an open sense of distrust about the nature of clinical trials – a fear on the part of some that they will be treated as a “guinea pig”. For patients who may be wary of research agendas (particularly when pharma-led) peer-to-peer education is a vital ingredient in building trust and confidence in clinical trials. Patient advocate, Stacey Tinianov believes “there is great value in patients and caregivers leveraging the connected platforms to educate themselves on the benefits and realities of clinical trials. Learning patient to patient is often more accessible for a variety of reasons, not the least of which is a certain trust”.

Moreover, social networking has the potential to empower patients and care-givers with a greater sense of control. All too often, patients who face serious illness can feel isolated and powerless; joining an online community can help enormously. By exchanging coping tips, offering encouragement and support, and sharing information on the latest clinical research, patients feel a greater sense of agency. Breast cancer survivor Diane Glassmeyer, took part in a Sierra-Stanford study of the effectiveness of support groups conducted via online video. The randomized clinical trial was designed to help researchers determine whether this type of video-mediated support group improves the well-being and quality of life of breast cancer patients who live in rural areas. Glassmeyer described the Skype Support Group as “an amazing experience to be able to see and talk to everyone in the group each week from all over the state”.

The role of the care-giver must not be overlooked in peer-to-peer support. Half of health information searches within the U.S. are on behalf of someone else. In the case of late stage oncology, or a paediatric trial, the caregiver’s involvement is imperative. We need to focus more on establishing communication and maintaining an on-going relationship, not just with the study participant, but with all involved in care-giving for the patient. Patient advocate, Andrea Borondy Kitts, a care-giver for her husband with lung cancer, says: “For the patient (my husband did not go on-line but I did) it was great to have technical help and sharing of latest research. I found out about Lucanix on the Inspire website and pursued it. When I needed to help my oncologist with the process of getting FDA approval for individual patient compassionate use, one of the Inspire members had the whole process documented and shared it with me”.

When Borondy Kitts’ husband was considering a clinical trial, she was able to get information from people with lung cancer about their experience, including side effects, with an experimental drug.  “When my husband had horrible side effects to his supposedly gentle chemo in Phase 3 clinical trial,  (Alimta /Pemetrexed), I found out from social media that many others had similar experiences and I also got tips on how to manage the side effects. My oncologist did not have enough patients in the trial to have observed these effects”.

 ePatient Reported Outcomes

Capturing Patient Reported Outcomes electronically (ePRO) through the web or mobile devices, offers a way to interact with trial participants, while also capturing critical data. Although patients for the most part face little or no restrictions on reporting their outcomes via social networking sites, there are some concerns about how this might affect the trial’s validity. Patients self-reporting on their trial treatment online and comparing notes with others may potentially jeopardize the trial. The exchange of personal experiences whilst enrollled in clinical trials can lead to patients (or any researchers on the same social network) to inadvertently “unblind”* themselves, leading to knowledge of treatment allocation. Concealment is crucial for unbiased reporting of results, and disclosures by one patient might unintentionally distort another patient’s awareness of their own symptoms, potentially skewing data reporting and potentially invalidating study results. The intersection of free speech, social media, and clinical research is still unchartered waters. Borondy Kitts, believes that while guidelines can be implemented to safeguard data integrity in a blinded trial, “for unblinded trials there should be very few limits on what can be shared.”

Patients Are Doing It For Themselves

The communication process which traditionally flowed from pharmaceutical companies to physicians to patients has been transformed by social media. Patients, who have traditionally relied on their doctors for information about the latest clinical research, are now realizing that information may be more readily found in their online patient communities. After she progressed following chemotherapy and radiation, Janet Freeman-Daily, a lung cancer survivor, took it upon herself to do her own research.

*A blinded study is a study done in such a way that the patients or subjects do not know (is blinded as to) what treatment they are receiving to ensure that the results are not affected by a placebo effect (the power of suggestion).

She found a molecular testing trial listed on ClinicalTrials.gov, and contacted trial sites until she found one accepting patients. The University of Colorado Cancer Center (UCCC) agreed to test her existing biopsy samples. Unfortunately, all her tests were negative.  However, she learned about more options online.  “Another patient told me I fit the profile of patients who had the ROS1 translocation,” said Freeman-Daily. “I was relatively young, had adenocarcinoma, was never a smoker, and tested negative for the three most common mutations.  He told me about the ROS1 trial, which he was in, and sent me the journal article with initial results as soon as it was published. However, my home hospital had not heard of ROS1, and did not know how to test for it.”  After she progressed following more chemo and radiation, Freeman-Daily contacted UCCC again and learned they had recently developed a test for ROS1.  This time her tissue tested positive, and she entered the ROS1 clinical trial in Denver.

Kathi Kolb describes the process of searching for a clinical trial after her diagnosis of cancer: “I searched the database of the National Cancer Institute and found a Phase 2 clinical trial to test a new medication to treat cancer-related fatigue in people with breast or prostate cancer. I had been doing a lot of research on the subject because I was suffering from horrible fatigue myself. Once I found a trial that fit and was close enough for me to get to, I followed the links provided and researched the cancer treatment center where it was taking place, as well as the clinicians in charge of the study. I was able to make initial contact with them by email. It was a really good experience overall.”

Janet Freeman-Daily, Kathi Kolb, Andrea Borondy Kitts, and Katherine Leon are part of a growing number of ePatients, empowered by the Internet and emerging new technologies, who are leveraging their online communities to drive and support the research agenda. From providing input into study design protocol, to raising awareness of the value of clinical trials and recruiting trial volunteers, patient influencers play a key role in accelerating the new research paradigm. AnneMarie Ciccarella, a patient advocate who serves on the Love Foundation Army of Women (AOW) Scientific Advisory Committee, believes patients have a valuable role to play in trial design. “The thing that interests me the most is trial design and having patients part of that process” she said. “Some grants require a patient advocate on the proposal. In some cases they are actively involved in the study design; in others, the researchers scramble to find an advocate before the submission deadline. I’ve participated as an advocate on a funded grant, possibly at the top of the list of things that mean the most to me. It’s about bringing patients and PIs [Principle Investigators] to the table when the questions are being formulated – a step ahead of actual trial design”.

The Future Is Social

 Ciccarella also serves on the advisory board of CureClick, an online platform which uses the power of crowdsourcing to share clinical trial information. As part of a group of key patient leaders, she helps recruit trial participant across all diseases. This new model of leveraging trusted patient leaders to educate their online communities about the benefits of clinical trials can do much to improve trial recruitment goals. CureClick ambassador Debbie Woodbury, explaining why she joined its advisory board, said: “I started working with CureClick early this year and serve on its advisory board because I feel that too often cancer patients find themselves in the curious situation of having too much, and too little, information. Many patients I’ve spoken to are overwhelmed with treatment decisions, and yet receive little to no information concerning clinical trials. The beauty of CureClick is the ease with which plain language information is shared peer to peer on social media, resulting in greater participation. It’s a win-win for everyone and I’m proud to be a part of it”.

The need for a faster and more globally scalable approach to trial recruitment, planning and design, is clear. To address challenges such as public awareness and understanding of clinical trials, increased competition for patients and decreased effectiveness of traditional advertising, requires new solutions. Social media are a key part of the solution. Social media offers patients greater accessibility and convenience of communication and information. For researchers, social media offers a unique opportunity for innovative trial recruitment modalities, increased efficiency and accelerated research outcomes. People are social creatures by nature; harnessing our innate desire for connection, to new information, social and technology platforms is the best chance we have to drive the next generation of research forward.

Refs

Malorye A. Can web 2.0 reboot clinical trials? Nature Biotechnology 27, 895 – 902 (2009).

 

 

 

A Patient Advocate Speaks Out About Clinical Trials

Obstacles and Progress in Clinical Trials

Laura Cleveland

Laura Cleveland is a 18 yr CLL patient, an impassioned patient advocate and a peer reviewer of late phase cancer clinical trials for the NCI Institutional Review Board (IRB), with focus on trial design, accrual issues, regulatory mandates and informed consent.

Cleveland has 12 years experience in designing, evaluating, and reviewing clinical trials, and I was interested to get her thoughts on the clinical trial process, obstacles that patients face and any recent progress being made in the clinical trial arena.

Obstacles to Clinical Trial Enrollment

It is no secret that clinical trials face accrual problems. Half of all phase III clinical trials close because of insufficient accrual with only 2% of cancer patients participating. In Cleveland’s opinion, some of the biggest obstacles are:

  • The myth that clinical trials are purely experimental and that the subjects are treated as “guinea pigs”. Cleveland explained that, in trials, patients are followed much more closely than they would be in normal treatment situations and that all standards of care actually evolved from clinical trials.
  • Logistics – Enrollment is often delayed due to eligibility criteria or rules and regulations concerning testing and screening.
  • Randomization and the fear of receiving “placebos” instead of cancer medication. Cleveland explained that placebos are rarely given in cancer clinical trials. When drugs are compared, the experimental drug is compared to the Standard of Care, She went on to say that there is even a push to remove randomization from certain trials and that there are currently single arm clinical trials available.
  • Cost – If insurance does not cover the costs of extra tests and doctor visits, it can be costly for the patient. There are organizations that help with these costs, but often the patient must bear the burden of significant cost outlay.

I asked Cleveland what the one thing is that industry/government can do to make the clinical trial process easier for patients. She had a very simple 3 word answer:

“Pay for it”

Progress Being Made in the Clinical Trial Process

When asked what progress had been made recently in the clinical trial process, including enrollment, navigation and process in general, Cleveland had several comments:

  • The patient materials are becoming more understandable and easier to read. The documents are being “translated” into plain language, the informed consent form is getting shorter and less complicated. Cleveland has been working with the National Clinical Trials Network on this for the past several years.
  • Patient-friendly clinical trial results are being published so that patients can read about these trials and understand them. Cleveland has been working with the Alliance for Cancer Clinical Trials on this.
  • Cooperative Groups have been working on ways to change the consent process and clinical trial protocols. These groups get together and discuss strategy to improve the whole clinical trial process to make accrual more attractive and patient-friendly. This is a slow process but encouraging steps are being taken. Cleveland said that patients are given a clinical trial “packet” that often, they do not understand. She further explained, “There needs to be a patient-friendly summary that the patient can read and easily understand before they even attempt to read the Informed Consent form. This summary needs to be in plain language and outline the clinical trial that they are considering.” Apparently, this type of summary exists for a few clinical trials, but it needs to be the rule rather than the exception.
  • Clinical Research and Clinical Trials need to be in the vernacular. They need to become everyday words and concepts. Social media is helping in this effort. Tweets and Facebook posts help with awareness. But there needs to be more effort in this direction. Possibly, clinical research staff could visit Middle School or High School and talk to the science or health classes about trials. Children can be great advocates of causes and could bring the word home to siblings and parents. Breast Cancer groups have done a great job for breast cancer awareness; they could really help by spreading the word about breast cancer clinical trials and clinical trials in general. Much, much more needs to be done in this area. Cleveland summarized,

 “As far as getting the word out about clinical trials, it’s just not there.”

In closing, Cleveland had several words to say to patients about self-advocacy.

“Get a second opinion! Seek out a specialist in the specific disease area that you have. Find out who is doing research in that area and contact them. Use all resources available to you. You must be your own self-advocate.”

Clinical Trial Process: A Physician’s View

Interview With Dr. Jeff Sharman

Dr. Jeff Sharman is Medical Director of Hematology Research at The US Oncology Network, one of the largest networks of integrated, community-based oncology practices in the US. US Oncology includes over 1000 physicians practicing at more than 350 sites in 19 states, and treats more than 750,000 patients annually. Dr. Sharman is also on the Patient Empowerment Network Advisory Board.

The US Oncology Research Network has enrolled over 60,000 patients in about 1,400 clinical trials so far. The website offers a trial finder that will connect you with a US Oncology practice near you that has clinical trials available.

Dr. Sharman is convinced that although research adds to a physician’s workload, it enlivens a practice and adds to productivity. In a video on the US Oncology website, Sharman says US Oncology found that physicians that recruit one patient per month on average are 70% more productive than their counterparts.

I asked Dr. Sharman several questions about the clinical trial process and he was kind enough to answer.

1. From the physician perspective, what are the 3 biggest obstacles in the clinical trial process?

“Regulatory oversight has become too burdensome.  In major academic centers and cooperative groups, it can literally take YEARS to open some studies – let alone accrue the study and determine the results.  Often the key scientific questions have changed before the study is executed and the results are no longer relevant by the time they are answered.  It is a case of “death by good intentions” to see such caution in clinical trials, but unfortunately, patients are dying while studies are acquiring the requisite signatures to get started.  In community practice, we are able to cut start up time to a small fraction of our academic counterparts, but the oncology practice environment these days makes it hard to fully engage in both clinical medicine and research.  Eligible patients are often not enrolled in clinical trials that are available at their own site because physicians are not able to slow down enough to connect the dots.”

2. What is the one thing that industry/government can do to make the clinical trial process easier? Why don’t they do it?

“Reduce the barriers to enrolling patients on clinical trials at the Medicare level and possibly even provide greater incentive to sites for quality research participation.  Medicare Advantage plans until recently had regulations that actually INCREASED the cost to patients to enroll on clinical trials.  Patients had higher copay (went from 10% to 20%) AND they lost maximum cap guarantee.  It was a powerful DISINCENTIVE to clinical trial participation.  That has been improved however Medicare is currently adopting numerous quality measures in reimbursement models to practicing physicians.  Research engagement could easily be included in these quality measures and would powerfully encourage participation.  Policies that are adopted by Medicare are often followed by major insurance carriers so there could be a spill over effect.”

3. Who are the major influencers in this arena? (This includes patients, advocates, industry, government and HCPs)

“Right now, virtually all power resides with the pharmaceutical companies.  They are the only entities with the budgets to sponsor clinical trials.  Government funding and grant agencies probably account for less than 10% of current clinical research in oncology.  Government could create tax incentives for pharmaceutical companies to provide research opportunities to investigators for more investigator initiated studies.”

4. What are the major positive changes that have been made to the clinical trial  process in the past 2 years?

“The agents used currently in clinical trials are based upon a far more detailed understanding of cancer biology than the cancer drugs of only 10 years ago.  With greater precision, drugs are often more effective with fewer side effects.  Furthermore, we are far more capable of understanding the unique biology of an individual’s cancer.  In the past, we might just call a disease by a specific name, but now we can often find the unique molecular heterogeneity within a single patients cancer.  This allows us to explore investigational therapies that may be unique to an individual patient.”

5. What is US Oncology Network doing in the way of clinical trial awareness for doctors and patients?

“Our network will enroll over 4000 patients to clinical trials this year alone.    US Oncology is a management organization for many practices and through thoughtful leadership enhanced the role of research within many practices.  US Oncology research has dramatically improved relationships with sponsors and sites to bring the best clinical trials to patients.  I could talk for hours on this.”

Thank you, Dr. Jeff Sharman and US Oncology!

Please discuss your treatment options with your medical team.

Does Patient Empowerment Lead to Better Cancer Treatment Outcomes?

According to a study presented at the World Congress of Psycho-Oncology (WCPO) in late July, 72.3% of patients diagnosed with cancer defer their treatment decisions to their doctor. While this number is not surprising, it is cause for concern.

With a diagnosis of cancer comes a barrage of possible options for treatment. Often, choosing between these options can be overwhelming and intimidating, especially as there is typically not a clear answer and many uncertainties in terms of potential outcome.

How can we help patients navigate these tough decisions, such as whether or not to get a second opinion or participate in a clinical trial? How can we help patients gain the confidence they need and help them feel empowered and in control as they discuss treatment options with their healthcare team?

 Helping patients self-advocate

A survey done last year by Patient Power of 1295 chronic cancer patients showed that 73% of those
surveyed said the health information they found online helped them feel more confident and more in control of their health (see infographic at the end of this post). Learning about your illness from experts and from other patients can be a rewarding and empowering experience.

Organizations such as the Cancer Support Community (CSC) and others, including us at the Patient Empowerment Network (PEN), offer programs to help patients stand up and advocate for themselves and become informed so that they, in partnership with their heath care team, can make the right decisions for them.

Programs and resources designed to empower patients

The study presented at WCPO found that educational workshops, such as the CSC’s Frankly Speaking About Cancer program, that aim to educate and empower those affected by cancer can have dramatic outcomes in terms of patient confidence in making treatment decisions. In fact, the study found that as a result of attending a Frankly Speaking About Cancer workshop, 85.5% of respondents reported having increased confidence in discussing treatment options and making treatment- related decisions with their health care team. (Harvey, et al 2015)

 

Live audience at a recent town meeting for patients

Live audience at a recent town meeting for patients

PEN’s Town Halls and Patient Café programs give patients and carers tools and resources to discuss treatment options, including clinical trial participation, with their doctor and their family and make informed and empowered decisions throughout their illness.

Participant surveys from these meetings are overwhelmingly positive. Over 80% typically rate the event as good to excellent, and many write in emails like the following:

 

 

“Thank-you for all you do and have done to help those of us with CLL better understand this journey we are traveling.   The information you give is such a great help when I talk with my doctors and just for peace of mind in better understanding what I am facing.  Mary”

Answering your questions about clinical trials

In addition to helping facilitate conversations about treatment decisions, PEN offers a comfortable and convenient place to find user-friendly information about clinical trials. One of our goals is to help you understand the process by introducing you to people just like you who have participated in, or are considering participating in, clinical trials. We also offer opportunities to hear from doctors, nurses, caregivers, caseworkers and others about their perspective on what it means to participate in a clinical trial.

Patients helping patients

"Powerful Patients" at a recent town meeting

“Powerful Patients” at a recent town meeting

There are many resources available to help patients navigate their journey and we encourage you to take full advantage of them. If you can’t find what you need, don’t hesitate to reach out to let us know how we can better help you. And, most importantly, please remember, you are not alone. We stand beside you as a community of patients helping patients.

 

 

 

 

Patient Power Infographic

Sources:

http://www.cancersupportcommunity.org/General-Documents-Category/Research-and-Training-Institute/Posters-and-Presentations/Factors-Influencing-Treatment-Decisions-Among-Cancer-Patients.pdf

http://www.patientpower.info/about/survey-results-2014

 

 

How a CLL Diagnosis Changes You

The fourth session of our virtual patient meet-up, Patient Cafe™ took place in June 2015. The topic of the discussion was “How did a CLL Diagnosis Change You?”

Carol Preston led the discussion as the participants discuss the impact of a CLL diagnosis. All participants had gone through some form of treatment although they may have started with Watch and Wait.

Participants talked about CLL changing their lifestyle. John spoke of the “sucker punch” upon receiving the diagnosis, his experience about getting a second opinion and subsequently getting treatment.

Sharon talks about receiving the diagnosis and being unsure of the meaning of it. She talks about her legs buckling when her first doctor suggested chemotherapy. She then decided to obtain a second opinion and went to a major cancer center. Sharon said she researched her illness because “that’s the kind of person she is”.

Betty had already had ovarian cancer and gone through chemotherapy. At a follow-up appointment, she was diagnosed with CLL. She had never heard of CLL and asked her oncologist what it was. Her oncologist gave her a book and told her not to worry. She decided then and there to go to a major cancer center and join a support group. She researched her illness and went to a specialist. She is now taking oral medication and says she feels wonderful!

Watch the video and learn and gain confidence from these EMPOWERED PATIENTS! You too can become empowered and be your own best self-advocate!

How a CLL Diagnosis Has Changed Us from Patient Empowerment Network on Vimeo.

The fourth Patient Cafe™ for CLL patients starts out by introductions all around. Carol Preston leads the group discussion about the impact of CLL on relationships and lifestyle. All participants have undergone some form of treatment although they may have started with watch and wait.

Success is Being a Survivor

Author and 3X cancer patient, Jodie Guerrero

Author and 3X cancer patient, Jodie Guerrero

Success means so much – its definition is reflective of the heart & soul of the perceived successor. To me – Success is not just about chasing a dream and securing it – true success is a lot deeper than pushing through a physical barrier to win the prize on the other side.

I believe true success is flying in the face of danger, marching towards the fire and leaning towards the negative perception that your efforts will reap nothing or your existence is un-important.

Success is proving that your hunch was right, your dream was correct and your gamble paid off – NOT because you put in resources to get back (something for yourself). But, rather you gave your all for the good of others, for the delivery of kindness, for love in the form of understanding and ultimately sacrificial leadership for the fulfilment of a need in your community. Success can take many years and in most cases it does. It’s a gradual slope of hard work and its rewards are up there – on top of the mountain.

Why do I believe this? I am a survivor of cancer x 3, medical negligence, a disability as a result and currently 77 doses of cancer treatments to keep me alive and very soon a bone marrow transplant. I’ve seen people lose their fight, right in front of me. I’ve heard people tell me to be quiet and stop fighting for the suffering of others. Success is being a survivor and that’s what I am!!

What do we need to be a survivor? What do you need to be a survivor? A very important element for me has been faith and foundation. My faith is everything and the family who love me, combined with my faith are my foundation. Without a strong foundation – we may topple and fall, either mentally or emotionally. However, many people find other elements of underpinning to keep them strong, through the largest hurricanes of life.

Even with these ropes of strength in our greatest storms, we may still topple – however a secure footing will help us find it easier to rebuild again and seek help when we need it. This may include a shoulder to cry on, someone to take us to medical appointments/assist with medication or someone to call a Psychiatrist. There is nothing wrong with asking for help, I believe it proves our strength and resolve.

Being a survivor takes a strong desire to continue no matter what, a resolve to not listen to the masses or those who do not support you – this may include family and friends. Believe it or not, when we have a difficult health journey, people walk away – even folk who should not or those we thought we could rely on. Some of us often discern these individuals, as they run for the hills and never return, yes – even those who are related to us.

We may not understand this behaviour at the time, but often the ones that run cannot cope with our journey (even if it’s a long-term success) and in the end, we may find that these relationships weren’t contributing to our health anyway. For myself personally – of course, there are days when physically I find my daily duties difficult to fulfil – these days, I discipline myself to know & practice when I need a little extra medication/a little extra rest and a little extra prayer, these things are what survival currently look like for me.

After my Bone Marrow Transplant, I will have less cancer pain and more resolve to survive in a different manner – I will continue forward and enjoy each day blessed and given to me. I will enjoy every day granted to me with the family and friends who love me and the ones that have stuck around – they are the ones we are surviving for. They are the people who value our survival – we may not realise how many people around us cherish our life and the energy we put into surviving, however, I know most of us have a good handful and many more supporters after that.

Treasure the people who cling to you and love your survival – you are worth more than all the gold and jewels, on our beautiful planet – your life and the days you have are more significant than you could ever know – just ask the people who love you.

Thank you for reading, please feel free to contact Jodie at the following email address: Jodie@jodiesjourney.com