A Patient Advocate Speaks Out About Clinical Trials

Obstacles and Progress in Clinical Trials

Laura Cleveland

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

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

Obstacles to Clinical Trial Enrollment

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

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

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

“Pay for it”

Progress Being Made in the Clinical Trial Process

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

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

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

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

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

Does Patient Empowerment Lead to Better Cancer Treatment Outcomes?

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

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

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

 Helping patients self-advocate

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

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

Programs and resources designed to empower patients

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

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

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

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

Answering your questions about clinical trials

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

Patients helping patients

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

Patient Power Infographic

Sources:

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

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

Success is Being a Survivor

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

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

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

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

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

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

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

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

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

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

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

Advanced Care Planning – What to Do Now!

This is important! And often overlooked, neglected, procrastinated, or ignored…for many reasons. If you are an adult, you need to think about your future and your wishes and desires in terms of your health care. And you need to discuss these wishes and desires with those close to you. It is only by doing this that you can ensure that your choices will be heard.

It is sometimes a difficult conversation to start, but those around you and close to you need to hear you. Start by thinking about quality of life, choices, and what is important to YOU. Think about who you can trust to listen to you and carry out your wishes if you are no longer capable of doing so.

If you are a cancer patient, think about what treatment options are available to you, what makes sense to you and what doesn’t. Do your research, talk to your provider or medical team and talk to those close to you. Then think about those discussions and what is important to you.

This is ultimately an individual and very personal decision. However, family members need to hear and respect your viewpoint, so include them in the conversation early on.

So many times, it happens that when a patient is unconscious or incapacitated in some way, family members get together and try to make decisions. Often, the family members cannot agree on what the patient would have wanted and their opinions and emotions cause conflict, anger and heartbreak. And then, since the patient never made her wishes clear, they are not carried out.

You can avoid this.

Take action now and start the conversation.

Once you have discussed your wishes with family members and loved ones, it is important to fill out the correct paperwork. Medical directives are legal documents that will state your wishes and help to see that they are followed. But do not rely on medical directives alone. Be sure to talk to family members or others close to you.

According to a recent article in the New York Times, large national studies showed that although more patients are completing medical directives, these directives are not always available to hospital staff when they need to be. Patients often keep them filed at home and they do not find their way into patient medical records or into the hands of those caring for the patient in an emergency situation. Be sure and make your wishes know to those closest to you and give them a copy of your directives.

Advance Care Planning is also a process. You can change your mind and may do that as time progresses. Be sure and update family members as your wishes change.

You do not have to do this alone. There are numerous avenues of help.

Resources

There are many resources that help with Advanced Care Planning. One good website is The Conversation Project.

Here, you can find information, a “starter kit” to help you get your thoughts together and start the conversation with your loved ones. This kit is available in Spanish, French and Mandarin as well as English.

There is also a PDF on how to have the conversation with your doctor, in Spanish and French as well as English. The website has a blog with patient stories and stories from staff members and advisors.

MD Anderson has an entire web page dedicated to Advance Care Planning . Specifically for cancer patients, this page was developed by an interdisciplinary team of doctors, patients, social workers, health educators and other health care professionals.

On this page, you will find step by step guidelines on how to start discussions with family members, talk with your provider, assign a family member to be your spokesperson and how to complete the legal paperwork necessary. PDFs are available in English and Spanish.

There is also a 5 part video series explaining the process of Advance Care Planning in depth with patient viewpoints and advice on how to make the decisions and discussions go as easily as possible.

The MD Anderson web page also includes information on Advance Medical Directive documents such as Living Wills, Power of Attorney and Out of Hospital DNRs (Do Not Resuscitate) with links to the legal documents and instructions and advice on filling them out.

This page is an excellent resource and also includes a number to call for further questions.

Don’t hesitate. Start the conversation now.

8 Beliefs That Can Hold Caregivers Back (from reaching out for help)

Family caregivers too often suffer from two very common things: overwhelm and isolation. Or, to it put another way, exhaustion and loneliness. So often, the nature of illness and trauma not only disrupts our normal ways of living, but also disrupts our connections with people who care about us. Caregivers who reach out for support gain the benefits of lessening their burdens and of feeling the warmth provided by people who care.

Too often, caregivers hold back from reaching out because of beliefs they have about doing so:

  •  Nobody else can do what I do for my loved one.
  •  My loved one won’t accept help from anyone but me.
  •  I’m too busy to even begin to think about doing anything more – even reaching out.
  •  The moment I start reaching out, our family will lose our privacy.
  •  I’m afraid of imposing on people.
  •  Reaching out shows weakness; doing it yourself shows strength.
  •  I’m afraid that nobody will come forward to help me.
  •  Since I’m able to handle things now, I’ll be able to continue to do so.

These, beliefs, while completely understandable and very common, are neither healthy for you as a caregiver or for your loved one. They get in the way of your resilience and your capacity to sustain yourself for however long your caregiving is required. Each week, I will be focusing in on one of these self-limiting beliefs and invite you to come along with me in exploring those that you are now willing to let go of and change into ones that help you not only survive, but thrive.

So let’s get started:

Nobody else can do what I do for my loved one

Think of the whole range of “things” you are currently doing. First think of the practical ones: dressing, managing and administering the meds, shopping, preparing, serving and cleaning up after meals, assisting with bathing and toileting, and so on. Now focus on the emotional and spiritual ones – showing love, being a trusted confidant, giving emotional support and comfort, etc.

Nobody else can do these things exactly how you’re doing them or would your loved one experience them in the same way if they were done by people other than you. No one else is so attuned to your loved one’s needs and preferences and, most likely, your loved one is most receptive to your way of doing these things. And, no one else would be as committed to your loved one’s comfort and be as vigilant as you are. This much is true.

But, the trap here is believing that, since no one else can do things the way you do, that no one else can do them or do them satisfactorily for you and your loved one.

Let’s take a look at some of those practical things that I listed above. Take one area for starters, e.g. grocery shopping. These days, it’s not like the days when our mothers used to look the butcher in the eye and tell him she wants a better cut of meat than the way he did it last week. Shopping simply means meal planning, list making and going out and getting the groceries – all very delegatable tasks. When you think about, I think you’ll agree that many if not most of the practical things can be done by others. Not necessarily with your intimate knowledge and way of doing things, but in their own ways. And, similarly, other people will bring their own and distinctly different ways of providing emotional and spiritual support as well.

Bottom line: Is this a belief you’ve been holding? If so, how does it serve you? How does it hinder you? How might you re-write that belief so that it serves you better? For example, “There are some things that other people can help with. I’m going to try this out with some simple things.” What practical step can you take to try out that new belief this very week? Let us know – by commenting on this blog. You’ll help yourself and other caregivers by doing so.

 

 

 

 

 

Twitter Tips and Resources for Cancer Patients

The “Twitterverse” is pretty mainstream now and not just for the younger generations any more. Of the many, many uses for twitter, cancer information, education and support are gaining ground. Twitter is fast, easy, mobile and instantly gratifying.  Information literally at your fingertips.

Several articles have been published on the increased use of twitter by cancer patients, from cancer patients tweeting through chemo, “power” cancer patient tweeters in Japan, and a controversial article in ASCO about a breast cancer patient tweeting about her disease.

Tweeting is easy. Set up an account and go! If you are interested in getting some good information back from Twitter though, you should choose carefully whom to follow.

All news sources are on Twitter, so it’s easy to find them and follow them.  All top cancer medical centers are on Twitter and they are a great source of information on cancer research, news, clinical studies and basic medical information. Here a just a few to start with:

@MDAndersonNews

@DanaFarber

@SeattleCCA

@MayoClinic

@MoffittNews

@LurieCancer

Patient support groups for cancer patients are numerous and you can usually find one that is specific to your illness. Again, here are some to start with:

@StupidCancer – mainly for young cancer patients

@ImermanAngels

@MyelomaCrowd

@MyelomaTeacher

@MyBCTeam – for breast cancer survivors

@CancerSupportCM

@PCFNews – Prostate Care Foundation

@PanCan – Pancreatic Cancer Action Network

There are many, many more – this is just a small sampling. To find specific groups or people to follow, you should use the search engine on Twitter or do a hashtag search and see what comes up. For instance, if you are interested in following groups or people that tweet about stomach cancer, do a search and research their profiles. For instance, I just searched “stomach cancer” and this is what came up:

You can now go to these twitter profiles and see if these are some people that you would be interested in following.

So you can go to these twitter profiles and see if any of them appeal to you.

It’s quite simple and you can follow some groups and people for a while and then “unfollow” them if their tweets are not what you were looking for. Once you follow people or groups that you know have the same interests as you, you can use them as your “news stream” and tailor your stream to the kind of information that is most suited to you.

Twitter is easy, quick and gets to the point right away (it has to – with only 240 characters allowed by tweet!) It’s a great way to keep informed and have custom-made information at your fingertips.

Can(cer) Do! – Why We Should Talk About Cancer

I saw two productions about cancer in a 48-hour period this weekend…and went home smiling.

The first, produced at Washington, DC’s Theatre J, was called The Prostate Dialogues. It was written and acted by a very fine local raconteur, Jon Spellman. In 75 minutes – with no break – John unfurled his prostate cancer story from diagnosis to his treatment decision (surgical extraction at Johns Hopkins). Along the way, Jon peppered his experience with humor and a graphic depiction, through a normal and happy cell called “Glen,” of the development of those nasty mutated cancer cells. A five-minute description of a 20-year process. Brilliant!

Two days later, my husband and I saw a newly released movie in the U.S., “The Fault in Our Stars,” based on the best-selling, young adult book by John Green. The movie had received excellent reviews, so despite the subject matter, we went to see it. It’s about two teenagers, each with terminal cancer, who fall in love. Hazel and Augustus are doomed. We know it from the start of the movie. And yet, the film was done with grace and understatement and humor. There was no hyperbole. The acting was honest including the antics of Augustus’ now-blind-from-cancer buddy Isaac. Was it heart-breaking? Yes. Was it sometimes funny and often uplifting? Also yes.

As a nearly eight-year survivor, I expected to shed many tears at this movie. It was my non-cancer husband who welled up and forced himself not to cry in public.

Here’s the takeaway: In the U.S., we are talking about cancer! We are talking and laughing about it a lot and in the open, often with people who don’t have cancer. Cancer no longer is quietly discussed in the back room, in hush-hush tones with family and our doctors. Cancer has seeped, no, it is flowing into the mainstream consciousness. The more we learn, the less we fear. The less we fear, the more we live our lives through family, travel and work.

The mantra of my doc at MD Anderson in Houston is to “live large.” In other words, say ‘yes’ to as many opportunities and invitations as possible. If you live in the DC area, go see The Prostate Dialogues. In the U.S., cry and laugh with Hazel and Augustus at “The Fault in Our Stars.” And remember, cancer is not a dirty word. It’s a condition that we face, like Hazel and Augustus, with grace and humor, and now more than ever, in the open.