Clinical Trials: Good, Bad & Ugly

Clinical trials for cancer patients can be a life-saving opportunity. But most clinical trials do not even finish due to lack of patient participation. Why is this?

One big issue is that many cancer patients do not hear about relevant clinical trials. Physicians often do not mention them because either they don’t know about them or because of time constraints. It takes a good deal to time to explain about a clinical trial to a patient and then to help walk them through the approval process and answer their questions. Many physicians do not have the time or the staff to do this. And often, cancer patients are too overwhelmed to inquire.

I asked Andrew Schorr, two-time cancer patient and founder of PatientPower.info, why he thought that more patients don’t know about clinical trials when they are first diagnosed with cancer. Schorr answers,

“When patients are just told they have cancer, they feel afraid and alone. They rely on their doctor for guidance and don’t think of looking elsewhere for information. It does not occur to them to think of participating in a clinical trial for treatment.”

I asked Jim Omel, a 13+ year myeloma survivor and retired family physician who has participated in NCI (National Cancer Institute) peer reviewed research and who is a patient advocate working withThe Alliance for Clinical Trials in Oncology,  about his thoughts on why more patients aren’t aware of clinical trials. Dr. Omel explains,

“We definitely need to elevate the consciousness of the public about clinical trials; there’s no doubt about that. We need to educate the public about the providing of tissue, sharing clinical data. So many people have this misconception that they are “guinea pigs” which is a term we all abhor.” But it’s a term that people relate to clinical trials; they see themselves as test subjects rather than receiving the best of care, the most up to date care that you get with a clinical trial. A lot of it is public perception. We have to change this. As cancer research advocates, we are trying our best to get the word out.”

The internet and social media have done a good job in trying to get the word out about clinical trials. The government website, ClinicalTrials.gov lists all trials by illness and location and includes some brief help topics and a glossary of terms. And Cancer.gov  lists clinical trials specifically for types of cancers.

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Some patient support groups like PatientsLikeMe have their own clinical trial search tool. I took a look at the PatientsLikeMe tool and it did seem quite a bit more user friendly than the government site. It also mentions how many members of PatientsLikeMe may be eligible for the trial, links to a glossary and to the government site for more detailed information. I asked Paul Wicks, Vice President of Innovation at PatientsLikeMe about the tool and he explained,

“PatientsLikeMe’s global clinical trials tool draws on open data to match patients from around the world with a wide range of clinical trials based on their condition, location, age, or any other criteria. Patients can search for and identify a range of trials using a simple interface, and create a profile so they can be automatically alerted to trials that match their criteria.”

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When asked about the efforts of individual foundations and organizations in informing their members about clinical trials, Dr Omel explains,

“In the case of myeloma which I am most familiar with, the Multiple Myeloma Research Foundationand the International Myeloma Foundation have done a pretty good job of educating myeloma patients about new drugs and research going on. If you think about it, we have had six new drugs for treatment of myeloma in the last decade and that is unbelievable progress in oncology. The myeloma community really does work together and patients realize that we have these new drugs because patients before us signed up for those clinical trials.”

Another big issue with recruiting patients for clinical trials is the complexity of enrolling in the trial itself. The informed consent process is difficult to understand and many patients are daunted by the process.

Physicians can help explain the process, but again, often do not have the staff or the time. Families often cannot help unless they are familiar with the process. Patient Advocates certainly can and do help if they are available.

There are many issues to be covered during the enrollment process. What is the criteria for enrollment? How far does the patient have to travel? Will the patient have insurance coverage for standard care during a clinical trial? Will the patient get the new fancy drug or will they get a placebo or other type of treatment? Will the trial accept patients that have other health issues like a heart or kidney condition?

Informed consent should be written for the patient, but it is not. Providers and drug manufacturers want to be protected and often the complex medical and legal terminology included in the document is discouraging to a patient.

Efforts have been made to simplify the informed consent process. Fact sheets have been developed and videos have been made that try and explain the process easily so patients can understand.

PatientsLikeMe offers their clinical trial tool that helps simplify the process for their members, and other patient support sites may help walk their members through the process or have tools to help simplify things.

During my research on this subject, I came across an interesting product and website. Mytrus Enroll is a software product that simplifies  the informed consent process. The Mytrus website states:

“Enroll is a gateway technology that allows critical disclosure information to be condensed into an easy-to-understand, digitized format using animation, interaction, and visual imagery. Patients can interact with the app, marking terms and concepts that they want to discuss, completing easy to use knowledge assessments, and providing regulatorily ccompliant signatures to indicate their consent.”Image

I spoke with Michael Tucker at Mytrus and he explained that Mytrus is making great headway in the clinical trial tool arena. The company started by developing technology as a response to patients who wanted to participate in clinical trials but lived far away from a trial site. Mytrus wanted these patients to be able to enroll and participate in a trial mostly from their own home, reducing the amount of times they would have to go to the trial site for visits. With the technology they developed, patients can enroll remotely and go through the screening process using the Enroll software.

Mytrus tries to give patients a better understanding of the informed consent process and the clinical trial screening criteria by video (see here for a sample video). All Mytrus and Enroll videos and information are IRB approved.

Tucker went on to say that several studies have been done to determine the effectiveness of the video approach to the informed consent process. One such study done at the University of California at San Francisco showed that the comprehension and recall rate was superior in the video approach (75%) as opposed to the paper approach (58%).  Better comprehension is better for the patient and better for the study overall. Tucker further explains,

“The conclusion from this that is usually drawn is that if you have a higher comprehension rate, you will get better qualified patients. More patients will participate if they understand what is going on.”

While efforts are being made to better inform patients and the public in general about clinical studies, and the internet and technology seem to be helping the informed consent process, there is still a long ways to go as far as streamlining or adapting the clinical study process to make it more patient-friendly.

A big deterrent to adequate patient accrual for clinical trial is the way that the studies are designed. Often, the screening is very restrictive. Patients with any other conditions or illnesses besides the condition being tested are not permitted to take part in the study, greatly reducing the pool of potential participants.  Furthermore, often the patients are randomized in the study and many may never receive the new important drug being tested. Understandably, many patients react negatively to this and will refuse to participate in such a study. These obstacles will be difficult to overcome. Statisticians that build these studies want the restrictions and the randomization. Until there is a resolution to this problem, patient accrual will always be an issue. In an article he wrote for theMyeloma Beacon, Dr. Omel comments,

“What good is a statistically perfect, well-designed trial if nobody shows up?  Our current system is broken and needs new approaches to randomize patients based on their informed right to choose their own treatment.  This profound decision affects their life and their cancer.  Treatment should be their choice…

To all who denounce such an unscientific approach, please outline an improved system based on a patient’s absolute right to choose his treatment.  We can ‘think outside the box’ and use a different approach, or we can keep the same system and get the same results—3 percent participation with many drop-outs.  Without a change, we will continue to observe that only a tiny minority of clinical trials open, accrue, close, and are reported in a timely manner with useful information for clinicians and cancer patients.”

Resources:

http://www.pmlive.com/blogs/digital_intelligence/archive/2013/december/digital_recruitment_for_clinical_trial

http://www.mytrus.com/

http://www.ihealthbeat.org/insight/2012/social-media-offers-new-recruitment-strategy-for-clinical-trials

http://www.sireninteractive.com/sirensong/dr-katz-from-fda-talks-social-media-and-clinical-trials/

http://www.eyeonfda.com/eye_on_fda/2011/12/clinical-trials-and-social-media-part-1-in-an-intermittent-series.html

http://online.wsj.com/article/PR-CO-20130705-906183.html

http://www.patientslikeme.com/clinical_trials

 

This post was originally published on HealthWorks Collective

How Chronic Cancer Patients Use Social Media to Stay Informed

New research and treatment has made many cancers that were previously terminal now chronic. Patients live with the condition and daily go about their lives. But often, they do have to manage their cancer and often they worry about reoccurrence, side effects from medication and progression of the disease.

The chronic patient is often “forgotten”.  They are under treatment, doing (fairly) well, and doctors and the media are focusing on the more urgent issue of treating the acute or advanced cancer patient.

Chronic cancer patients want to know and understand their disease.  They would like a cure and they seek out the newest and latest information online looking for answers on treatment options, and how to best live with their disease.

Where can chronic cancer patients go for help online?

There are numerous sites for help with living with chronic cancer.  Many are disease-specific, offering news about new treatments or research.  There are several good video channels that offer interviews with cancer specialists about treatments, clinical trials or other information on specific cancers.  There are patient support networks and numerous Facebook pages that offer patients the opportunity to connect with other patients and post discussions about all aspects of their disease.

There is an overwhelming amount of information online and often, it is difficult to sift through all of it.

I have listed a few of these sites below.  In no way is this a comprehensive list, but I have asked several cancer patients and opinion leaders for their input and have added their thoughts to the list.

Resources for Chronic Cancer Patients

Cancer.gov

CLL Global

Patient Power

CanCare

Oncology Tube

National CML Society

Leukemia Lymphoma Society

Patients Against Lymphoma

CLL Topics

Institute for Myeloma and Bone Cancer Research

The Myeloma Crowd

International Myeloma Foundation

 

Facebook groups

Essential Thrombocythemia

Myeloproliferative Neoplasms

Polycythemia Vera & Budd-chiari Syndrome Awareness

 MPN Forum

Myeloproliferative Neoplasms 

 

Patient Opinion Leaders and Advocates

Another great way to obtain information on chronic cancers is to follow patient opinion leaders (POLs) on social media channels.  These patients have been living with their specific cancer (or cancers) for some time and have spoken about their experience (often publically), written books and articles about it, formed groups or even organizations or companies around chronic cancer.  They have Facebook pages, tweetchats, blogs, video programs and websites.  They organize patient meetings, interviews with physician specialists and events around their illness.  They have the experience and know-how to conduct excellent informational programs for other patients; they are a wonderful source of information.

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Andrew Schorr, @Andrew Schorr, founder of PatientPower and author of the Web Savvy Patient has been in remission from Chronic Lymphocytic Leukemia since 2001.  In 2012, he was diagnosed with a second cancer, myelofibrosis.  Andrew now leads a normal life, thanks to a new targeted oral therapy.  He has been a leader in patient education since 1984 and is considered to be one of the most respected and reputable Patient Opinion Leaders.

When I asked Andrew why he did what he did, he responded,

“I feel a responsibility to try to help other patients do better because of something I’ve learned through my experience. While others might wish to protect their privacy I “go public” with the hope to ease the journey of other cancer patients like myself. It helps me feel I am doing something significant and helps all of us know we are not alone, but rather a real community.”

Patient Advocates also help other patients by coaching them through living well and coping with their disease.  They use social media to spread the word about their illness and educate patients around the world.

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I also spoke with Cindy Chmielewski, @MyelomaTeacher, a former elementary school teacher and a multiple myeloma patient that is now a patient advocate for the disease.  Cindy is on the Board of Directors of the Philadelphia Multiple Myeloma Support where she is in charge of the Patient Education Library and Patient Advocacy. – She speaks at support groups, tweets about myeloma, and participates in several online support communities.

When asked why she did what she did, Cindy answered,

“Everyone needs a purpose in life.  Being a teacher for 28 years before my medical retirement I knew my purpose in life was to be a facilitator of information. When I regained my strength after my Stem Cell Transplant opportunities began to fall into my lap. I had some very good mentors when I was newly diagnosed. I am very grateful that I able to pay it forward. Sharing what I learn gives my cancer experience a purpose. Using social media allows me to reach a larger audience.  I am still a teacher, but now I teach a new subject with different students. We are all in this together and we can gain strength from one another. My life once again has meaning”. 

The Power of Social Media

Social media has drastically changed the idea of patient empowerment. Patients all over the world can connect, educate themselves and their family members, network, and instruct and educate others. And they are doing just that. The day of the passive patient is over: Welcome, empowered patient!

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Patient Power!

This post was originally published on HealthWorks Collective

Spotlight On Imerman Angels: One-on-One Cancer Care

Screen shot 2014-04-12 at 5.44.36 AM“I’ve been there. I beat it. And so will you,” says Jonny Imerman, cancer survivor and founder of Imerman Angels, a cancer support group that matches cancer survivors to cancer patients on a one-to-one basis.

Diagnosed with testicular cancer when he was 26 years old, Imerman quickly learned that newly diagnosed cancer patients feel alone and afraid, and that support is key to improving mental and physical health.

Started in 2006, Imerman Angels now has a roster of over 6,000 cancer survivor mentors and caregivers. Over 400 different types of cancer are represented. Many staff members are also cancer patients and the small group runs largely on donations. Every effort is made to connect people with the same type of cancer, of similar age from the same city or town.

Imerman Angels operates in over 60 countries and when patients are not close geographically, they rely on social media and Skype to connect. Imerman mentioned that often, patients from other countries wanted to be matched with a US treated patient survivor as they respected US medical care and wanted to ask specific questions about treatment.

Imerman Angels accepts people of any age. Although initially, most patients were young adults, the average age has gone up significantly and currently is around 50 years old.

Imerman explained that the organization’s mission was getting cancer patients together, one-on-one, to share experiences and make the journey easier.

“Our whole mission is so simple.  If somebody is diagnosed with cancer, any type of cancer, anywhere in the world, there’s a survivor out there living with the same cancer and going through the same thing, and that person can help. Putting these people together in the same room is our goal, to empower the newly diagnosed patient by having him meet someone who has already been there.”

I asked if his patient mentors went through any specific training and Imerman answered,

“Yes, we talk to all patients and mentors and assess both parties and then make the best match. We talk to the patients and get to know them and figure out what they need. We talk to the mentors and make sure they understand how best to help the patients and support them through their diagnosis, treatment and life with the disease.

We have a training manual and a medical advisory board of PhDs, MDs, psychologists, social workers, nurses that helps us with the training program. We want to make sure that mentors understand their role.

We make a match only after we have assessed both parties and the mentor has completed the training.”

I asked about follow-up after the initial matching process. Imerman answered,

“Oh yes, you have got to check in. You cannot assume that the match on paper is going to be the best match. After 3 weeks, an automatic email is generated and sent to both sides asking if they connected, if they are satisfied, if they have questions or want to change anything at all. If there is any hesitation, we will look into the situation and change it.”

I was curious about the reception that Imerman Angels gets in medical institutions from doctors, nurses and the rest of the medical staff. Imerman was very enthusiastic.

“Almost 100% if not 100% of the hospitals are extremely receptive to us, that’s not the problem. They are all saying – ‘Wait, this is free? And it helps my patients? You’re going to do this program for us; we don’t have to think about matching patients within our own clinic? This is great!’

Many of the local Chicago hospitals sponsor our events. We have spoken at Mayo, City of Hope, MD Anderson, USC, Dana Farber. They love what we do and they believe in it. The problem is always keeping us on their mind. They are doctors and medical staff and they are trying to cure patients; I get it! But we want to make sure they keep us in the forefront of their mind going forward and refer their patients to us.”

Imerman firmly believes in online support groups. He loves it when people use his one-on-one approach and also join online groups or participate in local group meetings.

“It’s so individual. I think that people that are interested should take advantage of all that is out there. Find a support group; find a mentor through us that you can talk with. Find out what suits you best.”

The biggest challenge for Imerman Angels is growth. Last year, they helped a total of 2300 people, and they did this with a staff of 9.

“Our biggest challenge is learning how to grow. One thing that our board has helped us do right is that we are very mission-focused. One-on-one peer support for cancer patients. That is our mission. We want to own that space and do the best we can do”

For the future, Imerman says that they just want to grow and expand the mission to include more patients.

“Our plan is to reach from thousands to tens of thousands to hundreds of thousands to millions of people. The more people we reach, the happier we are.”

Please visit the Imerman Angels website to learn more about this great organization.

Resources:

http://www.imermanangels.org/

http://www.cnn.com/2012/08/23/health/cnnheroes-imerman-cancer

https://www.facebook.com/ImermanAngels

http://www.huffingtonpost.com/jonny-imerman/cancer-support_b_2442697.html

 

This post was originally published on HealthWorks Collective