Topic: Please, I need your input

I am preparing for a presentation on clinical trial recruitment, the Cholangiocarcinoma Foundation and other issues at the annual Drug and Information Association conference. 

As you know the NCI, FDA, NIH and others are engaging us advocates in identifying issues regarding the low participation in clinical trials. At present, many if not most of these studies already are being conducted outside the US, but it is crucial for these studies to increase in this country.

The UK for example is not experiencing any difficulties with enrollment.  In comparison to the US it is a small country with great infrastructure, allowing for easy access to institutions and physician's office. 

But, there are many other reasons as to why the US patient population is shying away from entering clinical trials. 

Would you please be so kind and share with me your thoughts?  Have you contemplated a clinical trial?  Would you consider entering a study? 


Thanks for any input you may be able to give to me and ultimately everyone else on this site and beyond.

Hugs
Marion

THIS INFORMATION IS NOT INTENDED NOR IMPLIED TO BE A SUBSTITUTE FOR PROFESSIONAL MEDICAL ADVICE. YOU SHOULD ALWAYS SEEK THE ADVICE OF YOUR PHYSICIAN OR OTHER QUALIFIED HEALTH CARE PROVIDER

Re: Please, I need your input

We actively pursued clinical trials when my wife was first diagnosed several weeks ago. In fact, we were excited to find one which my wife could participate that was also close to home (Sloan). However, it turned out the trial was put on hold because of problems getting the drug which served as a basis for this trial.

There was only one other trial in the US where my wife was a potential candidate. Not many options available (diagnosed with ICC).

Re: Please, I need your input

I can tell you why my husband didn't enter a clinical trial.  When he was first diagnosed, we were both so freaked out about the prognosis that we wanted to get started with chemo right away to start fighting the cancer. When that drug regimine stopped working, we found that he didn't qualify for some clinical trials having already had treatment of some sort.  I also found the process of looking for one very complicated, trying to judge whether he fit the inclusion criteria which was in some cases pretty extensive.  Bottom line, I think you need a doctor who encourages participation and would be willing to help you find one whose criteria you matched.  We didn't have that.

Re: Please, I need your input

From a new patient perspective (my wife was recently diagnosed with locally advanced Intrahepatic CC), I can see why clinical trials are not too popular.

Here is what I would say are barriers so far in my experience:

1. Trials are not a part of the diagnosis discussion.  Our oncologists simply have not mentioned clinical trials as something to consider.  I found out about them from my own research.  I would think this is a systemic reason across all cancers.

2. The need for a new patient to do something..ANYTHING..to start treating the cancer is very powerful.  We changed oncologists and Andrea moved her care to Stanford, and this delayed starting chemo by a week.  This felt like a huge delay that was terribly concerning.  However, once you start a therapy, that can severely limit your trial options.  Given the often bleak information you run across when you first start researching ICC, the need to begin may feel especially powerful for ICC patients.

3. I am not sure exactly why, but trials seem like they are portrayed as what you do after all standard options are exhausted.  Maybe this is a problem in the US?  So many cancer patients may feel like they have a pretty good shot with standard options that they have not yet reached the "hail Mary" stage of a clinical trial?  This is just a hunch on my part, as I don't have first hand experience.

Jason

Re: Please, I need your input

I can't add anything better than Jason.  Especially his point #3 above.  That is exactly how I felt about clinical trials - you go to them after all other traditional options were exhausted.  And again, as Jason mentioned, clinical trials were never mentioned to me.  I've brought them up recently but now that I've had chemo, traditional radiation and SBRT, I find I'm not eligible for a lot of clinical trials.

Mary

Re: Please, I need your input

Well, this is WAY after the fact, but at our first visit with our ONC after Teddy's Whipple he told us that he had no problem looking at trials. Since T had clear margins and everything looked good and we were so overwhelmed it all happened so fast. Trials was just something we put on the back shelf. It appears some ONCS mention it more don't.

Teddy ~In our hearts forever~ATTITUDE is EVERYTHING
Any suggestion I offer is intended as friendly advice based solely on my own experience. Please consult your doctor for professional guidance.

Re: Please, I need your input

For me, I looked for trials to see if I was a candidate, however, since standard treatment was suggested to me (whipple, chemo) I never really considered a clinical trial. 

I might have considered one if it had applied to me, however, no one even suggested it to me. 

It strikes me that it is often the patients job to search out clinical trials and I imagine most people just don't have the strength, time, or emotional reserves to do it.

Just some thoughts.
-Randi-

Survivor of cholangiocarcinoma (2009), thyroid cancer (1999), and breast cancer (1994).

My comments, suggestions, and opinions are based only on my personal experience as a cancer survivor. Please consult a physician for professional guidance.

Re: Please, I need your input

My oncologist at MDA did mention clinical trials at my first appointment, but it was presented as something we might try if standard treatment did not work.   I would consider a clinical trial.

Suzy

Re: Please, I need your input

I did a trial in Nashville at Sarah Cannon Research Center. I actually did that first. I was originally diagnosed as unknown primary with metastasized cancer. That was with 3 different biopsies. I asked my doc where he would go for a second opinion if it was him and he suggested them. Nashville had the results of my biopsies and they had a study that matched up to my tumor markers. At that point not having any idea..this was at least something that matched me. So I did that Phase 1 study that was nearing the end. All of the dosages had pretty much been figured out. It did cause my tumors to shrink for a period of time but gradually lost effectiveness and I quit study and went back to original oncologist. But I had also gotten the results of a genetic study on my biopsy and there was a 67% chance of CC. So I went on standard treatment Gem/Cis which also shrunk my tumors.
Like was mentioned before I think many people see studies as last ditch efforts. Also studies have rules and if you don't live near study site it's tough. So with CC which is rare where do people have to get to , to be in the study?

My personal viewpoint is so far they have not found a cure for this so current options at best prolong life for a short period of time (which is good!) but it's the studies I will need to look to for long term survival.
Cathy

Re: Please, I need your input

my husband looked into several clinical trials.

because of the "usual" late stage (3 or 4) diagnosis with this cancer--
he was not eligible to participate in the one that interested him most.

as someone else mentioned, if trials are not in your area (state/town/
close proximity) the cost of travel and staying in another part of the
country for an extended period of time can be make participation
very inhibitive   (cost wise).

there was one in Mass. that was ALMOST a fit for him--but he was too
far advanced (stage 4) and he also would have had to stay in Mass for
about 6 weeks (at his expense).

Re: Please, I need your input

Thanks so much for your comments.  I will present these comments at the upcoming ASCO closed door session and of course present at DIA in June.  Please, be so kind and follow with your comments, because all are important to pass on to the NCI, FDA, NIH, etc. 
Thanks for all your help.
Hugs,
Marion

THIS INFORMATION IS NOT INTENDED NOR IMPLIED TO BE A SUBSTITUTE FOR PROFESSIONAL MEDICAL ADVICE. YOU SHOULD ALWAYS SEEK THE ADVICE OF YOUR PHYSICIAN OR OTHER QUALIFIED HEALTH CARE PROVIDER

Re: Please, I need your input

I just had one of my craziest thoughts ever. Please feel free to disagree, this one is way out of the box! It is cwazy! What if! What if someone fit a trial but the cost is enormous because of a place needed to stay for like 4 - 6 weeks! I know I would have no problem to offer to stay with me? What about you?

Teddy ~In our hearts forever~ATTITUDE is EVERYTHING
Any suggestion I offer is intended as friendly advice based solely on my own experience. Please consult your doctor for professional guidance.

Re: Please, I need your input

Our house is alway is always open.....we would love to help someone.
Lisa

This Information Is Not Intended Nor Implied To Be A Substitute For Professional Medical Advice. You Should Always Seek The Advice Of Your Physician Or Other Qualified Health Care Provider

Re: Please, I need your input

Lisa, I just knew that!

Teddy ~In our hearts forever~ATTITUDE is EVERYTHING
Any suggestion I offer is intended as friendly advice based solely on my own experience. Please consult your doctor for professional guidance.

Re: Please, I need your input

When I was in Nashville I applied to stay at the Hope Lodge through the American Cancer Society. It is free and offers rooms with 2 beds and a huge kitchen with locked cabinets and refrigerators to store food to let you cook all your own meals. Plus many organizations would cook for the lodge. It was awesome and I met some really great people.

Cathy

Re: Please, I need your input

Hi Marion, This is a great question. I agree with everything posted above. Additionally:
* because there are so few options with CC, and it's so aggressive, we didn't want to gamble on something that hadn't been proven to have some success.
* searching the clinical trials database is exhausting. The descriptions/search terms don't seem to have a lot of consistency. You could search on cholangiocarcinoma and get one set of trials, and search on bile duct cancer and get another completely different set. Sometimes it's better to search for solid tumor and then narrow it down.
* it would be helpful to have a patient advocate who can search for trials for us.
* quality of life is a huge limiting factor. My husband doesn't want to be far away from us for months at a time. The kids need to stay in school, and I need to keep my job, so we wouldn't be able to travel with him.

Re: Please, I need your input

quality of life is a huge limiting factor. My husband doesn't want to be far away from us for months at a time. The kids need to stay in school, and I need to keep my job, so we wouldn't be able to travel with him.


^^^^^ yes! sweet green! those are HUGE as well!

Re: Please, I need your input

For the first two years of my fight, everything needed to be decided ASAP! A couple of months ago, the cancer spread to a new node, but the onc didn't feel it was "life threatening". So I decided to do the trial. Being otherwise healthy, I am a good candidate because I don't NEED immediate response this time. I WANT immediate response, and sure hope this new drug works.
I have an urge to help people, especially since the diagnosis, and this is the best way I know to do it.
The biggest problem I encountered was with insurance, which is a major hurdle for most patients. I think more of us would contemplate trials if insurance companies would be cooperative.

KrisJ
"Don't just have minutes in the day; have moments in time."
Any opinions I give are based on personal experiences, and are not based on medical knowledge. I strongly suggest receiving medical care and opinions.

Re: Please, I need your input

Thanks everyone.  This is helpful.  Today I will finish the outlines of the presentation, but please don't hold back from sending info to me. 
Thanks all of you wonderful people.
Hugs,
Marion

THIS INFORMATION IS NOT INTENDED NOR IMPLIED TO BE A SUBSTITUTE FOR PROFESSIONAL MEDICAL ADVICE. YOU SHOULD ALWAYS SEEK THE ADVICE OF YOUR PHYSICIAN OR OTHER QUALIFIED HEALTH CARE PROVIDER

Re: Please, I need your input

I am late but I found only two trials I could participate it, the paperwork requirements are steep and nyp hospital is terrible about getting out your medical records (almost impossible) and third, my oncologists are against the trials. That's a lot to go up against.

Re: Please, I need your input

My husband's first oncologist (who also pronounced him non-resectable with "a belly and chest full of disease," which --thank goodness!--was not the case) told us that because clinical trials were not supported by the available literature, that he did not recommend them to his patients. Of course, building a basis for future data-driven recommendations for patients seems to be the point, but at the time of the diagnosis we were too shocked to argue with the guy. Incidentally, he did not remain our oncologist for long.

In any case, our experience has been that the need to move forward with treatment options trumps the patience and persistence it takes to find and determine one's eligibility for a study. Additionally, it takes a cancer research team to figure out where the trials are being held and how you might fit into their protocols. Since my husband has been through two different kinds of chemo and a resection in the four months since his diagnosis, we find that he's no longer eligible for a number of trials that we've researched. I do not think that we would have been willing to allow the cancer to progress while we waited around to determine whether or not we fit the parameters of a trial. The day that Dr. Selby--an amazing, brilliant surgeon who sees possibilities where other physicians see boundaries--pronounced my husband resectable, he was ready to climb onto the table with whatever butterknife and bandaids were available.  At that point, no trial was worth waiting for. We saw a path that gave us hope, and we jumped on it.

Re: Please, I need your input

Hi Marion,

Saw this piece on the news here in the UK today and thought that it might be of interest to you with regards to your clinical trial presentation.

Big rise in volunteers for medical trials -

http://www.bbc.co.uk/news/health-22594635

Video piece that was on tonights news -

http://www.bbc.co.uk/news/health-22655025

Hugs,

Gavin

Any advice or comments I give are based on personal experiences and knowledge and are my opinions only, they are not to be substituted for professional medical advice. Please seek professional advice from a qualified doctor or medical professional.

Re: Please, I need your input

My MIL looked into a clinical trial at Mayo.  A major reason for not entering it was because the costs, if there were complications were not covered.  One of her two insurances was not going to cover Mayo anyway, so it could have potentially cost her money to be a part of the trial.

Re: Please, I need your input

Thanks so much for your responses.  It pretty much sums it up:
1.  patients and physicians are not aware of the study
2.  physicians not pro-study
3.  patients have to find their own study, try to understand and see if it presents a reasonable choice.
4.  Inconvenience and cost involved prevents people from entering studies
5.  Other treatments are available

Thanks again, please don't hesitate from adding to the above.  I still have some time to make changes to my presentation
Hugs,
Marion

THIS INFORMATION IS NOT INTENDED NOR IMPLIED TO BE A SUBSTITUTE FOR PROFESSIONAL MEDICAL ADVICE. YOU SHOULD ALWAYS SEEK THE ADVICE OF YOUR PHYSICIAN OR OTHER QUALIFIED HEALTH CARE PROVIDER