How to Prepare for a Second Opinion Doctor Appointment

Expert physicians and cancer patients agree that getting a second opinion is crucial, even if you are very pleased with your primary medical team. It is your health and your life; take care of yourself!

A second opinion will help you learn more about your illness and treatment options. What you learn also will help you communicate intelligently with your medical team to get the best, most personalized care.

But doctor appointments can be scary, overwhelming and intimidating. There is the possibility of bad news and the apprehension of receiving confusing an difficult-to-understand information. Here are some tips to help you make the most of your second opinion appointment.

Prepare in advance

Plan to take a trusted friend or family member with you

This is critical. Memory retention is only 10% and less when you are stressed. You will not remember everything that is said during the appointment. You need to have someone there with you to be ‘another set of eyes and ears’. Then you can discuss key points with this other person to make sure you both heard the same information, go over options, and, if appropriate, ask for their input and opinion,

Record the conversation

Ask the doctor if you can record the conversation. Pull out your smartphone and record it! Then you can play it back at your leisure and discuss it with your family and the person who accompanied you to the appointment. You can then go over key issues, play back critical discussions and not miss anything!

By the way, many expert physicians have endorsed the idea of recording the discussion at a doctor appointment so don’t be afraid to ask!

Think of questions to ask and write them down ahead of time

No one thinks and speaks at the same time and does it effectively. And stress adds to the mix. So plan ahead and write your questions down to prepare yourself for the appointment. For example:

  • Confirmation of diagnosis
  • What are the next steps?
  • Am I eligible for a clinical trial?
  • What are my treatment options and does the second opinion doctor agree with the original treatment options?
  • What are the side effects of the treatment options?

If a clinical trial is advisable, you can ask these questions:

  • What is the purpose of the study?
  • Who is sponsoring the study, and who has reviewed and approved it?
  • What kinds of tests, medicines, surgery, or devices are involved? Are any procedures painful?
  • What are the possible risks, side effects, and benefits of taking part in the study?
  • How might this trial affect my daily life? Will I have to be in the hospital?
  • How long will the trial last?
  • Who will pay for the tests and treatments I receive?
  • Will I be reimbursed for other expenses (for example, travel and child care)?
  • Who will be in charge of my care?
  • What will happen after the trial?

Bottom line: You do not need to become a medical expert in your disease. By following the guidelines above, you can become more knowledgeable to make informed decisions about your path to improved health and quality of life.

 

 

Be Your Own Best Advocate

(Editor’s Note: Gina Goldfarb is a cancer patient and founder of New Beginnings Coaching Services, LLC, which helps women with breast cancer cope with the emotional and physical challenges of a cancer diagnosis.)

Gina Goldfarb

Gina Goldfarb

I have walked in your shoes. I have been in the shoes of a caregiver and I am a breast cancer survivor and I am a certified professional coach with a niche in survivorship.

I have seen firsthand how being your own best advocate throughout the cancer experience can give you your power back and get that feeling that you really are in control at this time.

It all comes down to choices. As a coach, the value that I deliver to my clients is around educating them on how we show up daily in our experiences, providing awareness to them, showing them that we do have options and choices, despite the fact that we are experiencing very heavy emotions and may feel like we are at the effect of what is happening to us. We can often feel like we are “victim” to our experience, our doctors and our caregivers, but that is just chatter that our mind creates. It is also completely valid and normal for what we are going through, but we can shift our energy to a more empowering place where we start to be the cause of our lives, meaning we jump into the driver’s seat and take back control by becoming an active participant.

Patients need to educate themselves about their disease so that they can have intelligent conversations with their doctors. In this age of technology, we have so many resources at our disposal online. There are so many websites, support groups and organizations that offer information about a particular condition. We can look into conventional medical treatments and alternative treatments that compliment each other. It crucial that patients avail themselves of these resources to better understand their condition and treatment options.

When I was initially diagnosed and went through the series of testing that brought me to a place where my doctor told me I needed a mastectomy, I had already known what I was going to do, but I pursued the following dialogue with my breast surgeon: The conversation went like this: “I understand what you are telling me medically, but I want to ask you this a question…as a woman, what would you do if you were in my shoes?” Her answer was quite poignant and exactly the choice I had made before I even posed the question to her. Her response was: “I would probably have a double mastectomy.” I told her that is what my choice in my gut was and where I wanted to go with this. Thank God I went with my gut, because after surgery they found more tumors in one breast and pre-cancer in the other breast! Based on my experience and my own research, I knew this was the right choice for me. I was my own best advocate!

I just had an experience with a client where she felt like her doctors were ignoring her concerns and putting off her surgery for more than a month because of their scheduling. She told me she felt victim to and at the control of her doctors. Having a relationship with your doctor is like having a relationship with any other individual in your life, it has to be reciprocal and it has to feel right. She called me to check in a few days later and told me that based on our last coaching session, she had seen other doctors and was now looking at different options and resources. She took additional action to reach out to other doctors who understood the urgency of her disease and she was now having surgery in just a few days instead of waiting and delaying the disease growing in her body for an additional 30 days as her original doctors had advised her. She took a proactive role in her health based on her own research and knowing that she had other options!

Our medical doctors are experts who are focused on medicine and getting us healthy. They treat us depending on what we tell them and if we don’t take the time to dig deep, do our own research, ask questions and tell them all of our concerns (even if we feel like we are taking their time up or being “annoying”) it is something we have to do! If we don’t ask questions our doctors are only going to act based on what we are telling them. If we don’t have the right relationship with our doctors it may affect our energy level and how we move forward in our action.

The bottom line here is that no matter what your diagnosis or prognosis is, we have choices! We have options, resources, the right to second opinions, we have the right to ask questions and a choice on what energy level we are going to live in each day living our lives each day moving forward.

 

 

 

 

 

“Well, You Don’t Look Sick”

A Phrase Commonly Heard by MPN Patients

 

"You look fine to me!"

“You look fine to me!”

(Editor’s Note: This post was written by PV patient, PEN Advisory Board member, and PV Reporter founder, David Wallace. The post was originally published in the PV Reporter.)

Isn’t it amazing how well we look?  In a group gathering of MPN patients you will see very few wheelchairs, walkers, canes, portable oxygen tanks or other medical devices required for daily living.  Behind the facade of  “well-appearing” individuals, we silently suffer from a long list of symptoms including:

  • Fatigue, the #1 complaint and it can be debilitating at times
  • Pain (which can manifest itself in bones, joints, abdomen, back, arms, legs….and the list goes on)
  • Itching (more formally called pruritus in the medical world)
  • Headaches
  • Gout
  • Neuropathy
  • Dyspnea (a fancy medical term for shortness of breath)
  • Constitutional symptoms
  • Night sweats
  • And the list goes on – more symptoms here

I doubt there are many among us who have not heard family or friends utter the familiar phrase“you don’t look sick.”  Not really something we want to hear as it diminishes the “quality of life” struggles we go through living with MPNs.

Living in the “World of the Well” and the “World of the Sick”

MPN puzzle

Human Jigsaw Puzzle

Although we walk proudly in the “world of the well”, many of us live in the“world of the sick” or perhaps bouncing between the two worlds depending on our blood counts, spleen size, level of fibrosis or other intangibles.  Almost like a “dual citizenship”, we stand among the chronically ill.  Recent estimates put Chronic Illness at about 50% in the United States.  Many myeloproliferative neoplasm patients suffer from multiple symptoms turning us into “human jigsaw puzzles” waiting to be put together by doctors who frequently disagree on a standard course of treatment.

The Spoon Theory

Why all the ramblings about symptoms and issues we all know?  The above is a preamble to a post I read recently called the Spoon Theory by Christine Miserandino.  She suffers from Lupus and provides an outstanding narrative on living with a chronic illness – using spoons as an analogy for how much energy she can expend in a given day.

While Lupus in not an MPN, the article stands as a common thread for all of us who live with “invisible chronic illness.”

The upside: live every day to the fullest!

Current and Future Treatment Options for Polycythemia Vera

In this video clip from The Conversation: Polycythemia Vera, the participants discuss current and future treatment options. Dr. Verstovsek, Dr. Heaney, and Bob Rosen all agree that the future holds promise for PV. Research is increasing and new treatment options are on the horizon.

Current and Future Treatment Options for PV from Patient Empowerment Network on Vimeo.

This site provides general information. Please talk to your own doctor to make healthcare decisions that are right for you.

What is Polycythemia Vera?

Join us in “The Conversation: Polycythemia Vera (PV)” as Dr. Mark Heaney, Dr. Srdan Verstovsek and PV patient, Bob Rosen, discuss the symptoms and treatment options for Polycythemia Vera.

In this first video, participants discuss the biology of PV and the symptoms. Please see other videos from this program here.

What is Polycythemia Vera? from Patient Empowerment Network on Vimeo.

Clinical Trial Design: How Can Patients Help?

During the sixth session of the Patient Cafe™, participants were asked, “How could patients help in clinical trial design?” The discussion centered around making the clinical trial enrollment process and participation more transparent and easy-to-understand. Some takeaways from this great discussion:

  • The informed consent documents need to be shortened and clarified, with language that the average patient can understand.
  • Clinical trial sponsors need to be more understanding of patients’ schedules and commitments  when asking for tests and appointments. Patients should be made aware of what tests are required before the trial begins.
  • Logistics should be considered and discussed at the outset of the trial.
  • Tests and drugs should be paid for by clinical trial sponsors. When patients are told that a test is needed for the trial, but the cost is the patient’s responsibility, they feel that they are just being “used” for the trial.

How Could Patients Help Design Clinical Trials? from Patient Empowerment Network on Vimeo.

Six Lessons Learned From Breast Cancer

BCAM

“The period of greatest gain in knowledge and experience is the most difficult period in one’s life.”  — Dalai Lama

Writing in Oncology Times, radiation oncologist, Matthew Katz MD, described cancer as an illness of transformation. “Biologically” he wrote, “it represents a change in growth and homeostasis. Metaphorically, a cancer diagnosis can transform how you see yourself and the way you experience life afterward.” When the dust settles after the cancer storm has passed, it is not uncommon for patients to reappraise their lives. Cancer forces us to slow down and look at what really matters. Caught up in the routines of daily living, it is easy to avoid doing this; but cancer stops us in our tracks and pushes us to the edge of what is familiar. With cancer there is no hiding place; its sharp glare strips away pretence and artifice, revealing the true nature of our lives and relationships.

Cancer is an invitation to take stock and re-examine your life, to discover ways of leading a more meaningful and fulfilling life. Richard G. Tedeschi, PhD, professor of psychology at the University of North Carolina Charlotte, reports five common growth outcomes from interviews he conducted with trauma survivors.

  • A deepened appreciation of life.
  • Enhanced relationships with others.
  • An appreciation for personal strength and endurance.
  • Setting out on new pathways or pursuing new interests and opportunities.
  • Spiritual growth and development.

As part of breast cancer awareness month, I extended an invitation to six women to share what they have learned from their personal experience of breast cancer. Their answers to the question, “what did cancer teach you?” reflect the themes identified by Dr Tedeschi. The women’s experiences span a trajectory of breast cancer from recent diagnosis and active treatment, to several years’ post-treatment.

Elizabeth McKenzie, a licensed psychologist who lives in Seattle, WA, was diagnosed with breast cancer in 2012. She learned to appreciate the value of stillness and find healing in solitary pursuits.

“When I was diagnosed with cancer in 2012, I knew that I had just been enrolled in a crash course with countless learning objectives. Some of the lessons, however, have been unexpected.

I learned to appreciate stillness, the silence in life. I am an extroverted person. I work as a child/adolescent psychologist. I am married. I am a mother. I am a daughter and a sister. I have many friends. Before cancer, I thought that the foundation of my life was largely my connection with others. The time I was forced to be alone to heal from many surgeries for my own health, led to my pursuing other solitary pursuits, mindfulness meditation, nature photography, personal writing, and exercise.

Over time, I have learned that my individual experience was also part of that foundation; to have time alone to live in mindful stillness is a basic need for my mental and physical health, one that I had long neglected. In working on this solitary foundation, I have also strengthened my connection with others. I am now giving serious consideration to attending a residential mindfulness retreat, one that would require that I be silent, except for counseling with teachers, for 3-7 days. That is something that in the past, I would have considered myself neither able to do nor willing to give myself that kind of time. Today, I feel emotionally and physically ready for the experience of being by myself, with myself, surrounded by nature, for days on end. This gives me sense of peaceful willingness, a gentle hopefulness, in a life full of uncertainty.”

Becky Hogue, a PhD Candidate (Education) at the University of Ottawa, was diagnosed with breast cancer in 2014. Becky wanted to share a cautionary tale so others could learn from her hard-earned experience.

“When I think back about one thing that I’ve learned, it is that treatments change over time but advice is full of ‘old wives tales’ which are often based upon older treatments. This was never more poignant than during my last round of AC chemotherapy. Throughout AC chemo, I had been suffering from nausea. I knew from support group that people who tolerated it well only had nausea for three to five days. I had nausea for at least eight days. Given I was on a 13-day cycle, this meant more days with nausea then without. Now, my nausea was never really bad. When I complained to my oncologist, he asked me “when was the last time you threw up?” Never. My nausea was never that bad, it just lingered.

The folks at support group (especially those a year or so ahead of me) would talk about different nausea meds. The meds I was on were not the meds that everyone was talking about. I found myself wondering if I should be on different meds? In my mind, a change of meds would mean less nausea. I would tolerate the chemotherapy side effects so much better.

What I didn’t realize was that these different nausea meds were the old school meds. The meds my oncologist had me on were the new ones. People in support groups, and some of the older chemo nurses, were not familiar with the new meds. The recommendations I was getting about ‘what works’ were ‘old wives tales’, and I bought into them instead of trusting my oncologist.

For my last bout of AC chemo, I tried a different combination of anti-nausea meds. My oncologist was away, so his nurse practitioner changed my meds (in part because I asked for it). I’m sure that if my oncologist was there, he would have explained that I was on the new meds, but also that they were doing their job. I didn’t know the other option was the older option. I didn’t realize that the folk lore about the effectiveness was in part just because it was the older meds. The new meds had not been around long enough to be part of the lore. With the change my nausea was no better, but the side effects of the meds were much worse. I ended up with terrible mouth sores (so bad I needed liquid morphine to manage the pain). One of my biggest regrets regarding my treatment was that I changed anti-nausea meds for the last cycle of AC chemo.  I had forgotten my own advice. I had forgotten who I had decided to trust (my oncologist), and let the ‘lore’ effect my treatment.

This tale is meant to be a cautionary one. Not so much about seeking advice, but about remembering that people who have followed this path before you did so at a different time. The treatment options (and side effect management options) available to you today may not be the same ones that were available for someone else a year ago. Although older treatments may work, chances are the newer ones are better. Before changing treatment plans based upon what you are hearing on the net or in support groups, ask yourself ‘is this an old tale’? And finally, decide who you are going to trust, and trust them.”

Audrey Birt, a two-time breast cancer survivor, focussed on lessons of courage, connection and resilience.

“Cancer taught me I’m more resilient than I would have believed, it helped make me braver. It also taught me that life cannot be controlled. This made me more able to live in the moment and for the moment and that’s probably not so good for my bank balance but it’s great for my life balance in a way. It taught me to reengage with writing through my blog and in a funny way it changed my life and connection to others. But it also taught me my fragility and that’s a lesson I’m still learning, one day at a time!”

Author of From Zero to Mastectomy, Jackie Fox, has written of how breast cancer “gave me part of myself back”.

“One of the obvious benefits of cancer is reconnecting with friends and family, but old loves like art and music may reappear in your life as well. In my case, I started writing poetry again. I hadn’t written or published anything for nearly 20 years and I really thought that part of my life was over. I’m so grateful to have it back and I hope I never lose it again.”

Liz O’Riordan was diagnosed with breast cancer in July 2015. From her unique perspective as a consultant breast surgeon, she is learning what it’s like to be a patient from the other side.

“Being a patient in my own speciality has opened my eyes to a lot of little things that could be changed to improve patient care. I learned that the language of cancer is completely different for a patient compared to a doctor. I have been made acutely aware that some of the phrases I’ve used in clinic when breaking bad news, that I’ve heard others say, or come up with myself, now make me cringe. A lot of women get recalled from screening with tiny low grade cancers (<1cm), and I’ve said “If you’re going to get breast cancer, this is a good one to have”, or “You’re lucky that we caught it early”. All of these phrases were said with good intentions, to try and reassure the women that they were unlikely to die of their cancer, and would not need chemo. And most women are still in shock, so I never see them truly react to what I have just said. But no cancer is a good one to have, and no-one is lucky to get cancer. I will pay close attention to what I say to patients in the future.”

The final lesson is one of authenticity and integrity, something Eileen Rosenbloom who was diagnosed with breast cancer in June 2010, believes cancer cannot take away.

“Although I often felt like cancer was a thief that had taken everything from me, being so ill also created an opportunity to see what it could never take — the very essence that is me. Sometimes I’d look at my eyes in the mirror and think: There I am, right there. I’m still me. It felt empowering to realize no matter how dark things got, I still had control over some part of myself. My very essence remained intact, even if stripped down to a raw version without any frills.”

Whatever place you are at with a diagnosis of breast cancer, there are lessons to be learned. These will be unique to you; but you can also learn from those who have walked this path before you. Reach out to them, and lean on their experience to help make the way a little smoother for your own journey.

The Need for Doctor/Patient Communication

The Need for Doctor/Patient Communication from Patient Empowerment Network on Vimeo.

Dr. Verstovsek and Dr. Heaney explain that patient education and doctor/patient communication is crucial for good patient outcomes.

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.

What It Feels Like to Have Breast Cancer: Diary Entry

Diagnosed With Breast Cancer May 14th, 2015

Caught incredibly early, I am very lucky! I had a lumpectomy on May 22nd. It did not spread to my lymph nodes. I start chemotherapy on July 17th. It will only be 4 treatments 3 weeks a part. Then radiation followed by hormone therapy. The worst part of all of this so far is watching my loved ones reactions to what’s going on with me. I’m hoping this forum is a place where I can vent my frustrations and not see how it effects the people that care for me. Sometimes I just need someone to listen and not say or do anything. I’m hoping I have found the place I can do that!

One Month LaterBreast_Cancer_Entry2

Augh!! – That’s all I can say right now. That’s not true it’s just how I feel. I shaved my head last Friday before work because I couldn’t stand the hair coming out in chunks. GROSS!! It was so GROSS! And then I felt FREE totally free from that anxiety. Relieved and Happy. I almost love my bald head. Almost!! But that didn’t last long. Now I hate it that everyone knows. I no longer have control of who I tell, if I want to tell. Cancer again has taken something away from me and I HATE IT!!!! I HATE IT!!!!! And don’t get me started on the pity looks. Please stop looking at me with pity. My life is great. I am loved more than I deserve. My support group is unbelievable. Everyone should have the good that I have in their life. Why isn’t it enough? Why do the pity looks upset me so? I wish I could get a temporary tattoo on my head so people would think I’m a bad ass instead of a sick person. Is it wrong to feel this way? Then the guilt sets in. I feel guilty because this is only an inconvenience. I will recover and be able to do the things I love. It’s just a sucky roller coaster ride that I am not enjoying….. Did I mention I love roller coaster rides? Trying like hell to make the best of things and feeling like I’m failing miserably……..

Three months after diagnosis…

I have made it! 10 days after my last chemo treatment, 30 lbs. heavier, with neuropathy in my hands and feet I was up on one ski. No one was going to judge me. I had done it!!! So as I let go of the handle and slowly sank into the brisk fall water I let go! I let the sobs come and released all that cancer and its treatment held over me. It was one of the most monumental moments of my life. At that moment I knew I was not only a fighter, but a survivor as well.

 

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.

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.