rejected from weight loss study because of breast cancer history

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Jyber
Jyber Member Posts: 38

I need to vent.

 I am over a year past treatment (mastectomy and chemo) and now just on femara for four more years. I am feeling very grateful and ready to take on my "second gift of life" full force.

One remaining issue that I have struggled with for a long time is weight. I heard on NPR about a clinical study being done by a major research university in my region. They were soliciting volunteer subjects for this study, which would compare two diets. You needed to be overweight and diagnosed with Type 2 diabetes. (Hey, I met the criteria!)

I contacted the coordinator by e-mail, provided my height and weight, and mentioned that I had been successfully treated for breast cancer in 2007, and had had chemo treatments. She wrote back that I seemed to fit the criteria for the study, explained more about it and asked me to call her if I were interested.

I made the call, and again mentioned that I had been treated for breast cancer and did NOT want to waste any time if that would be an issue. She said she would double-check with the nurse practitioner, who needed to review my medications, but it should not be an issue. I asked her to let me know immediately if she got a "NO" from the nurse practitioner -- that I would not want to waste time pursing this if I would not be in the study, Again, this coordinator told me she saw no problem and to assume I would be in the study.

She sent me paperwork for my primary doc to complete. Because she wanted it returned promptly, I ran it over to my doc's office with a cover letter and request that she turn it around quickly. I also offered to pay any fee in connection with the paperwork, as it was many pages of responses from my doc. I picked up the paperwork a few days later and paid a $25 paperwork fee (fine by me, as I appreciate that doctors do need to be compensated for things like this). Primary doc completed all the papers and said "no contraindications to participating in the study."

Meanwhile, I got myself very pscyhed about being in this study, which would combine behavior management sessions with one of two diets being tested. The study would run for two years (one with lots of sessions and the second year mainly a follow-up). I knew it would be a major commitment but felt that I would take the commitment to the trial seriously and thus be highly likely to stick with the program/study, as opposed to doing it on my own or with Weight Watchers.

I also had mounds of paperwork to complete myself -- data on weight of family members, detailed medical and lifetime weght data, an essay on my motivation, LOTS of personal info, a depression questionnaire, MANY detailed questions on lifestyle, eating and exercise habits, psychological questions, etc. This took me many hours to complete.

I was asked to come to the medical center (in a city in my region) for a 1 1/2 hour initial appointment which also involved a 45-minute drive one-way) and search for and cost of parking. The study does not reimburse for expenses. I set aside a day for doing this.

With all my and my doctor's sompleted paperwork, I met with the study coordinator who took my papers to review and left me to read the official authorization paperwork. She first weighed and measured me.

Within a minute or two she returned and told me that while she knew I had told her I had had breast cancer, she had just learned from the nurse practitioner that that disqualified me from the study. I broke into tears of frustration. I had raised this issue several times during the initial screening purely to avoid it coming to this point!

The coordinator told me that the nurse practitioner had been on vacation when we had first spoken and written weeks ago, and only now had this been discussed.

IMO this should have been discussed well before I took this trip into the city. If the NP was on vacation when I asked the question, the coordinator either should have gone higher up to the study managers/directors to get a response, OR should have run this past the NP once she was back from vacation -- not waited until I was sitting in the office with all paperwork done and paid for and my car in a paid spot with gas used for the trip. NOT to mention my time on a beautiful day, and my psychological investment and consequent letdown - the biggest issue for me.

The coordinator made a point of telling me that she took "full responsibility" for the mistake, (reminds me of John Edwards LOL) and also that this was "not a case of cancer discrimination."

I am frustrated and disappointed at how this was handled.

Reactions??

Suggestions??

THANKS!

Comments

  • winner
    winner Member Posts: 50
    edited August 2008

    Jyber,

    Personally, I wouldn't be part of a weight loss study with my health history.  I see it as too risky.  Maybe there is a reason why things turned out this way. 

    Just a thought.

  • roseg
    roseg Member Posts: 3,133
    edited August 2008

    I think that's pretty stupid. You don't have cancer now, what difference does it make if you were treated for it once.

    Since you got all psyched up for the study/program, why not use that positive energy and sign on with another? Try weight watchers or something.

    No need to let all that momentum go to waste just because they're a bunch of idiots. 

  • Jyber
    Jyber Member Posts: 38
    edited August 2008

    Both my oncologist and my primary doc have stressed with me how important it is for me to now focus on losing weight. This study did not involve any medications -- just one of two healthy diets and behaviour management with a focus on controlling eating and doing exercise.

    I really feel it would have been "the answer" for me at this point. It is a NIH federally funded study through a top medical center.

    I have tried Weight Watchers in the past and it has worked for me when I stuck with it. But with WW I am only responsible to myself. With a study I knew I would feel a commitment to the reserachers and giving good data to medical science to benefit others. The two-year commitment would, I felt, keep me "on the wagon."

    I may try WW again but it feels same old, same old to me and this study opportunity had me psyched.

    Thanks for the responses. I needed to vent. I wonder if they thought I was a "bad risk" because I might recur. I can understand that but feel the process was mishandled.

  • lvtwoqlt
    lvtwoqlt Member Posts: 6,162
    edited August 2008

    Jyber, These studies have such specific protocol listed in the requirements for the study that the coordinator should have known that a dx of cancer would have excluded you from it. She should have also checked with the nurse before sending you all the paperwork to do, even if it meant you starting the study late.

    Sheila

  • AnnNYC
    AnnNYC Member Posts: 4,484
    edited August 2008

    Oh Jyber, I would be upset, too!

    I don't understand why the study coordinator does not have a complete list of inclusion and exclusion criteria in front of her to consult at any phone call about the study??!!!

    I'm a little wary of other people calling me "negative" for sharing in your frustration, but...

    Let me say that I am NOT a nurse practitioner, but have more than 10 years of experience with a few clinical trials at a major academic medical center -- including writing the grant applications, the protocols for review by the Institutional Review Board and for use by the investigators, the patient informed consent forms, the progress reports AND handling phone calls from people who want to participate in the study -- and it's a hallmark of well-designed studies that the inclusion and exclusion criteria be clearly stated.  "History of cancer" or "previous neoplasm" is a frequent exclusion criterion.  If it really was the reason to exclude you from the study, it should have been on the list, and I can't imagine why a study coordinator couldn't understand and convey that information herself!  And if she couldn't, then you're right, she should have relayed the question to someone higher up in the study.  And -- in my experience -- studies are so eager for enrollment that a Principal Investigator (and by extension, the NP who wants to stay in the PI's good graces) would gladly take a phone call on vacation if it meant upping study enrollment! 

    I think you could basically send in the story you have written here, and send it to the Principal Investigator.  You could say that you would appreciate an apology, and assurance that this is atypical and won't happen to someone else. 

  • Jyber
    Jyber Member Posts: 38
    edited August 2008

    Thanks, Ann, your comments are very helpful. Sending a strong letter is what I am considering doing. I wanted other reactions/feedback before doing so. This study is through the University of Pennsylvania.

  • AnnNYC
    AnnNYC Member Posts: 4,484
    edited August 2008

    Hi Joan -- well, now I have the answer to the PM I just sent you!

  • Jyber
    Jyber Member Posts: 38
    edited August 2008

    Ann, I just responded to your PM.

    ALL, I do feel a bit guilty venting about this when I realize how fortunate I am to have this be an issue. If my primary doc had not found my lump back in 1/07, I would likely be dealing with much more stressful issues than rejection from a weight loss trial. To some extent, I feel like a spoiled brat to be whining about this considering other issues I might have had -- or might have in the future.

    In general, I am full of gratitude for my second gift of life. But now I want to focus on making the most of it, and losing weight is part of that agenda for me -- so I can make the most of my saved life!

    Thanks, ALL, for reading and for letting me vent, and for the feedback. I am feeling better already. Laughing

  • Anonymous
    Anonymous Member Posts: 1,376
    edited August 2008

    Jyber, the same thing happened to me with an African-Americans and Asthma study. After all the intake and stuff, I got a call the day before I was to come in to do an initial pulmunary function test and told I wasn't elligible because I haven't been NED for 5 years (it will only be four in November). I specifically asked about it at the initial meeting, too! Grrr!!

    I understand how you feel... 

  • ps123
    ps123 Member Posts: 221
    edited August 2008

    Here's a link to what sounds like the study you were interested in:

    http://clinicaltrials.gov/ct2/show/NCT00729196?rcv_s=08%2F04%2F2008&count=1000

    It lists the eligibility requirements and also the exclusion criteria.  I can't see any mention of having had cancer being an exclusion.  It does list treatment w/steriods as a reason for exclusion but I don't know if that would include and steroid you may have taken as a premed for chemo or not.

    Pat

  • mke
    mke Member Posts: 584
    edited August 2008

    If you want results, find out who is funding this study and write a detailed letter - more or less your vent, but include more details of dates and cost, and send it to everyone possible.  That means the CEOs of the funding organization and the hospital, the doctors associated with it, the quality assurance and/or patient relations manager at the hospital.  Heck do a cc to everyone possible.  Do not do an e-mail, make it a letter and add photocopies of any reciepts.

    It will cost you a bit in paper and postage, but I bet you will get your costs reimbursed.  And I bet they will clean up their act.  This might sound vindictive but it really is public service.  There was careless protocol for this study, for you it was an great inconvenience, in another case it might be a life risk.

    Few realize the power of a well written complaint, especially one that is widely distributed.

  • Mary-Lou
    Mary-Lou Member Posts: 2,230
    edited August 2008

    I still believe Weight Watchers is the very best way to go. It is a lifestyle.

    Check out my weight watchers friend. She is a firm instructor.

    http://www.freewebs.com/dimpledn/

  • Jyber
    Jyber Member Posts: 38
    edited August 2008
    Thanks, all, for the additional responses. I will work on my letter today. Once that is dealt with, I will do some thinking about how to handle the weight loss issue  -- want to do this slowly but surely!
  • Jyber
    Jyber Member Posts: 38
    edited September 2008

    Just wanted to let all those interested know that I got a thoughtful response from the pricipal investigator of the clinical trial.

    He sent me an e-mail of apology, and said he would look into the matter more and get back in touch.

    He called today. He said he fully agreed with me that this had been very inappropriately handled on his end. He has addressed this with the person who had coordinated the enrollment of subjects.

    Re participation in the study, he said the study was without a medical director originally and now has one. It was subsequently decided that a history of cancer within five years would disqualify a subject. The protocol will be revised to reflect this.

    The reason for the cancer exclusion is that 1) there is the risk of recurrance which might mean such a subject could not complete the trial and 2) clinically, a significant weight loss could be a symptom of recurrance and how would they differentiate between weight loss as a result of the trial and weight loss due to a recurrance? He advised me to work with my doctors on monitoring my weight loss just to be aware of this concern.

    Anyhow, he did offer me the opportunity to choose either wing of the program, and while I could not be part of the trial, he would assign a grad student to monitor me weekly through whichever wing of the trial I would choose. I thought that was a gracious offer and told him so, but I have decided to do Weight Watchers locally. I figure without being in the actual clinical trial I would not have any particular commitment to the program so might as well do something local.

    In any event, I do think changes were made as a response to my experience.

    Thanks for the interest and feedback.

  • iodine
    iodine Member Posts: 4,289
    edited September 2008

    You did a great job!  I am so proud of women who stand up for themselves and let "powers that be" know when things are off track and need to be reviewed.

  • Daffodil
    Daffodil Member Posts: 829
    edited October 2008

    Good work, Jyber!!! I so admire women who effect change!

    Hmmmm..............Wink

  • kerry_lamb
    kerry_lamb Member Posts: 778
    edited September 2008

    Well done, girl! But are you sure about non-participation? I reckon it's a great offer, especially the weekly consults..like having a personal trainer!

    The reason I am saying this is that it gives you an excellent forum to explore the connections between weight-loss and recurrence. All the current research talks about obesity as being the big thing to deal with as far as survivors go. You, a SURVIVOR who is taking your health 'bull' by the horns..I say you could be excellent in this trial! You are so committed to your 'second half-century'. Might be some photo opportunities too! Kiss Your experiences will inspire others anyway, whether it's the trial or WW. Good on you!  

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