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Knocking Down Barriers to Accrual Using Social Media

Social Media uses powerful tools that can be used to dispel myths about clinical trials and to engage patients.

(Editor’s Note: Cindy Chmielewski, a myeloma patient, member of the PEN Advisory Board, and longtime patient advocate and teacher, presented a poster exhibit at the recent 2015 AACR conference on the use of social media for clinical trial accrual. Below is the poster description and an image of the poster)

Multiple Myeloma is an INCURABLE cancer of plasma cells. Many researchers feel that a cure can be found in the near future if clinical trials which test their hypotheses are properly designed, fully enrolled and completed in a timely fashion. As a myeloma patient it is frustrating to hear that less than 5 % percent of adult cancer patients participate in clinical trials and that 24.4% of cancer clinical trials close early because they fail to complete enrollment. As an independent patient advocate I have made it my mission to use Social Media to knock down barriers to trial accrual.  Social Media provides powerful tools such as online patient communities, Twitter, podcasts, Facebook, patient blogs, and YouTube that can be used to dispel myths about clinical trials, excite the population about the successes of recent research and educate potential participants and physicians about clinical trial options.  According to the Center for Information and Study on Clinical Research Participation (CISCRP) an overwhelming majority of people (77%), say that they would consider getting involved in an appropriate clinical research study if asked. Since many doctors aren’t asking patients to participate in clinical trials patients need to be educated and empowered to question their doctors about ALL their treatment options, including trial participation. Social Media has helped me evolve from a passive by-stander in my medical care to an engaged partner and it is my mission to use it to help fellow patients.

Social Media and Clinical Trial Accrual

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.

Spotlight on PCORI: Progress in Patient-Centered Outcomes Research

Spotlight

I had the chance to listen to a live webcast of the PCORI Annual Meeting recently and was impressed about what they are doing and their thoughts about where they want to focus their energy in the future.

The Patient Centered Outcomes Research Institute (PCORI) is a non-profit organization that funds comparative clinical effectiveness research focusing on patient-centered outcomes. Their mission statement is:

PCORI helps people make informed healthcare decisions, and improves healthcare delivery and outcomes, by producing and promoting high-integrity, evidence-based information that comes from research guided by patients, caregivers, and the broader healthcare community.

The Annual Meeting took place over several days and included a number of excellent speakers. You can read

Panel Discussion at the PCORI Annual Meeting

Panel Discussion at the PCORI Annual Meeting

more about the meeting here and listen to the archived websites here.

There were over 200 patients and representatives from patient organizations present at the meeting, and many participated in panel discussions or breakout sessions.

Some takeaways from the webcast were:

  • Patients need to be included in every phase of research, from concept (topic selection) to proposal to design, dissemination and evaluation of results
  • While typical research answers whether A is better than B and is done with the smallest possible trial based on sample size estimation, patient-centered outcomes research needs big trials that address differences that matter to patients, differences in context (socio-economic, for instance) and trials that are multi-centered and international.
  • To get to big trials, researchers need to collaborate instead of compete. PCORI made engagement fundamental; it needs to now make collaboration necessary and essential.
  • Patients are not waiting quietly any more. They are seeking answers. To illustrate this, a speaker quoted one of her patients as saying, “You say there is a 3% chance of this happening, but if it happens to me, it’s 100%”
  • If a patient’s treatment is not aligned with their personal life, then it is not meaningful.
  • Dissemination is so very critical to this research. The results need to be disseminated to the right people quickly.
  • After dissemination of results, guidelines and regulatory change is needed to effect clinical change.
  • Changing practice takes time. Patients have to be disruptive to get change initiated. Tara Montgomery, Senior Director of Health Impact at Consumer Reports put up an excellent slide showing 5 questions that patients should ask their doctor about screenings or treatments:
  1. Do I really need this test?
  2. What are the risks involved?
  3. Are there simpler, safer options?
  4. What happens if I don’t do anything?
  5. How much will this cost and will my insurance pay?

Sharon Levine, MD, Pediatrician at Permanente Medical Group of Northern California and member of the PCORI Board of Governors, spoke of 3 gaps that need to be closed in integrating decision support into the workplace:

  1. Knowledge gap
  2. Knowing gap – dissemination of knowledge
  3. Knowing/doing gap – need to understand how we structure incentive programs and need to measure what people are doing and use these measures for performance improvement

Dr. Levine also stated that there is a definite need to better explain probability and uncertainty to patients.

The thread running through this meeting was that change is difficult, and in order to effect change in clinical practice, there is a great need for patients to be involved in every stage of research and for the research to be disseminated effectively so that it can be acted upon in a timely manner.

 

 

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.

A Patient’s Perspective on Clinical Trials

(Editor’s Note: This article is in two parts. This is Part 2 (go here to read Part 1) and consists of an interview of Celine Delaloye, a professional working at a pharmaceutical company and an HER2 breast cancer-positive patient. The interview is 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 patient. You will be surprised to see that the issues, thoughts, concerns of patients and doctors are the same. These issues are worldwide!)

As a professional working in a pharma company, Céline Delaloye (28) is no stranger to clinical trials. Here, she discusses her personal experience as an HER2 breast cancer-positive patient.

Interview With Celine Delaloye

Christine Bienvenu (CB): How did you learn about the clinical trial you are part of, and what convinced you to enroll in it?

Céline Delaloye (CD): It was thanks to working for a pharmaceutical company that I first heard about the clinical trial, and given my job, I’m well aware of how difficult it is to enroll in trials – let alone get accepted. As a professional, I’ve drafted many a quality of life questionnaire for clinical trials, and my professional insights really helped me when I, all of a sudden, was a patient myself.

My oncologist explained to me what a Phase II randomized study was, with the “random” part meaning that I couldn’t choose which group I’d be part of. Again, thanks to my professional background, I already knew a lot and didn’t need further convincing. But for my husband, it was really important to get a second opinion. Luckily, the oncologist we met with spoke very highly of the clinical trial, boosting our confidence about it being the best possible treatment available.

 

CB: Because of your job, you’ve seen how difficult it can be for patients to meet Phase II clinical trial eligibility criteria. Does that make you feel fortunate about access to the clinical trials, or frustrated that more patients can’t benefit – or did you even think about that at all?

CD: Like you said, I knew from my professional background what I was up against. My husband, though, was afraid I’d be used as a “guinea pig”. And it’s when I heard those words – “guinea pig” – that it struck me how the words “clinical trial” can really scare people. They’re in the dark about the details; to them, it’s like some kind of experimentation.

I honestly feel very fortunate that I was accepted into the clinical trial because I had the “luck” – if you want to call it that – of meeting all the criteria. I’m proud and happy to be part of a clinical trial. But I’m fully aware of the fact that not everyone has the same opportunity.

 

CB: How did you feel when you were accepted: Happy or apprehensive? What were your hopes and fears when you enrolled in the clinical trial?

CD: Initially, I was really happy in the sense that there was no doubt at all about my meeting all the acceptance criteria for the trial. I was excited. Scared. A bit of everything. My professional experience pushed me to learn as much as I could about the clinical trial.

To be honest, though, as a patient, I just needed to understand every aspect of it. But when I started reading all the documentation related to the study, its possible side effects and outcomes, I became more apprehensive: Which ones would I have? When I started the first cycle, though, I realized that we’re all unique in how we react. Just because potential side effects were listed didn’t mean that I’d have them. Two treatments in, I saw that I wasn’t experiencing every side effect, and felt more reassured about continuing the treatment with confidence.

And oh my goodness, the paperwork! I found it completely overwhelming, to be honest. But I just took it one step at a time. That’s the only thing you can do, really.

 

CB: Be honest, how hectic were the logistics of being part of a clinical trial?

CD: As a professional, I hadn’t had to deal with the emotional component of being part of a clinical trial. As patient, I did. As a patient, at intellectual level, I needed to understand all of the protocol tests associated with clinical trials to feel reassured and feel confident about continuing.

To be honest, I was never discouraged by the number of appointments related to the clinical trial. Sure, logistically, I needed to make sure my baby and husband were okay, but I have an amazing network of family and friends who have supported me throughout. At no time have I wanted to stop treatments: I’m more of the mindset of, “The faster we start, the faster the results”, right?!

 

CB: How supportive was your medical team in helping you deal with logistics?

CD: They were amazing, across the board – seriously. All the oncologists and nurses were so accommodative of and flexible with my schedule, needs and requests. They really made my life so much easier. Keeping up the busy pace of appointments was never an issue.

 

CB: Based on your experience, what would you tell anyone considering enrolling in a clinical trial?

CD: As both a professional and a patient, I’d encourage others to look into clinical trials, gather extensive information, ask their oncologist questions, and go for it. In my mind, it’s the best thing that can happen, treatment-wise. But I know how difficult it can be for so many, given just how stringent the acceptance criteria are. And for me, that’s a problem. Get out there, don’t sit back. Be proactive! Learn everything you can… Talk to your doctor: in my view, as patients, we’re a crucial part of the team!

 

CB: As a patient, do you feel information about clinical trials could be more available or easily accessible?

CD: Personally, I think every patient should be informed of any study, regardless of eligibility or where they are being treated. It is both the patient’s and the doctor’s responsibility to learn about clinical trials. When you are first diagnosed, your world crumbles. But information is knowledge and power… It’s so important. In my view, all hospitals – university and private – should be part of raising awareness in patient circles about clinical trials by hosting regular information sessions. If patients had easier access to information on clinical trials, I think they’d be naturally more inclined to look into their eligibility.

Another aspect that I think is often overlooked – but very important – is this: If a patient isn’t accepted into a clinical trial, what support networks are available for them? They have just as many hopes as the rest of us and shouldn’t be left behind. I was just lucky enough that I qualified fully for the clinical trial, so this deep disappointment wasn’t ever anything I had to deal with. I feel very lucky in that respect. But I do wonder about the support network for those patients who don’t qualify.

 

CB: Any parting thoughts?

CD: As a patient, it’s important to remember that when you accept to be part of a clinical trial, you also have every right to back out – at any time. It’s also important to know that if the disease progresses, a patient runs the risk of being removed from the study. I also firmly believe in the patient being proactive and informed every step of the way.

 

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

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

Getting a Second Opinion

“Get a second opinion!”

This is important! Who doesn’t get a second opinion when having work done on their car or house? Isn’t your body and health more important!

Go to a specialist and get a second opinion. Travel the distance if need be. Your health is so important. You don’t have to be followed up on every visit by a specialist if you live far away, but you owe it to yourself and your loved ones to have a specialist on hand as the “architect” of your healthcare treatment plan. Cancer is a serious disease and the specialists see only cancer patients day-in and day-out – they are the ones who keep up with the latest news and treatment options. They are the ones who have access to clinical trials and can let you know all the options there.

Watch the following video from our recent town meeting for lung cancer patients and listen to the panel discuss the importance of getting a second opinion:

Getting a Second Opinion from Patient Empowerment Network on Vimeo.

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.

The Bureaucracy of Clinical Trials

At a press interview with Dr. David Stewart, Head, Division of Medical Oncology, University of Ottawa, Dr Stewart laments the extreme inefficiency of the clinical trial process. Patients are dying while government is regulating. The clinical trial process is too long, too costly and too inefficient. Watch this video from The World Conference on Lung Cancer that recently took place in Denver, Colorado:

The Bureaucracy of Lung Cancer Clinical Trials from Patient Empowerment Network on Vimeo.

When a Melanoma Diagnosis Brings Clinical Trial Options

36 year old Female diagnosed with Stage III Melanoma on May 19, 2014

Diary Entry

I’m fairly new to this fight and not exactly sure what to even expect. Since my diagnosis, I had one surgery to cut off the melanoma (it was on my toe) along with a 3 week recovery while unable to work. It took three weeks for the biopsy to come back. I guess hearing the doctor say that the pathologist said that they had never seen anything like it, isn’t a good thing. Next, was an amputation of that toe, along with Lymph Nodes from my groin area. Those results did not bode well either. Out of the 3 that he removed had a tumor in it. So, my journey next took me to Baltimore, Maryland where I met with an oncologist surgeon. I had a complete dissection on my left groin area. During my follow up visit I found out that the doctor removed 11 lymph nodes and two more came back with cancer cells. I was readmitted to the hospital thinking that my incision was infected. It wasn’t, but the drains weren’t working all that well either. The doctor opened my incision and my wonderful husband has become my nurse and packs the incision twice daily. I couldn’t be luckier than having such a wonderful husband. During all this, I learned that I am extremely claustrophobic. That puts a slight crinkle in trying to have all these tests that I need to have. I try to stay optimistic and keep my sense of humor.

Clinical Trial Options

So now I am exploring clinical trial options.  I have asked for more information on Yervoy, with everyone’s advice. In my area, to receive Yervoy for stage 3 melanoma, you have to be part of a clinical study or whatever. My doctor promised I wouldn’t be given a placebo. But, I would have to travel quite a distance. I know that there are quite a few of you on here that have traveled for treatment. But, for me, right now, it’s just not an option. I have teenage children that need me to be home. I could never do this alone. My husband would be with me, which would leave no one at home…. I am starting on Paxil this week and should (depending on my insurance) start treatment next week. I have had two people on Treatment Diaries tell me about Yervoy and I don’t want you to think that I am not listening to your advice. But I have had 5 doctors tell me that interferon is probably in my best interest. I don’t know how this is going to go. I’m hopeful, and again, I won’t be alone. My husband has and will be with me for the duration of all of this.  I am hopeful!

Real patient experiences shared privately at www.TreatmentDiaries.com.  Read more, share if you like or join in the conversation.  Making sure you feel less alone navigating a cancer diagnosis is important.  Connecting you to those who can relate and provide support is what we do.

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 Clinical Trials Work?

Patient Empowerment Network, in association with Patient Power, hosted a town meeting for advanced prostate cancer patients at MD Anderson Cancer Center. This event was attended by over 100 patients, caregivers and family members and live-streamed to an online audience.

During the Q&A period of this meeting, one participant asked the expert panel about clinical trials and how they work. The panel responded by discussing trial availability and eligibility criteria. The town meeting host, Jeff Folloder, a cancer patient, relayed to the panel his experience with clinical trial participation at MD Anderson.

Jeff explained that his medical team at MD Anderson really researched all clinical trials available and picked the best one for him according to his particular situation. Zita Dubauskas, the Physician Assistant on the panel, further explained that during a trial, the patient is very carefully monitored and scrutinized for side effects by numerous other medical personnel and really gets an extra level of medical care.

Watch the video and learn more!

How Do Clinical Trials Work? from Patient Empowerment Network on Vimeo.