rejected from weight-loss study due to previous breast cancer

Jyber · 08-20-2008, 01:35 PM

I need to vent.
I am roughly 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!

Gerri · 08-20-2008, 02:14 PM

Jyber,

Wow! I got frustrated just reading about your experience.

Yes, the coordinator should have checked with someone higher up to make sure she was answering your question correctly. It is so frustrating when you try so hard to make something happen only to be turned away due to the incompetence of others.

Do you have access to the trial criteria? If so, does it state that having been treated for cancer excludes you from the study? If there is nothing in the criteria stating this and you are interested in pursuing it, you may be able to contact the Principal Investigator in the study and ask for confirmation that you do not qualify.

If this doesn't work out don't let it undermine your determination to lose weight. I too am on Femara and need to drop the pre-cancer and post chemo weight that I have put on and just signed up for Weight Watchers at work. I am really hoping it works for me but am concerned that Femara (causes weight gain) and another non-cancer related drug I am on (also causes weight gain) will make it hard for me to lose. I am really determined to do this so hopefully I will be successful.

Good luck getting some answers. If ultimately you can't get in the study, maybe a try at Weight Watchers or something similar is your next best bet.

All my best,

SoCalGal · 08-20-2008, 04:28 PM

Hi -
I have been on a gluten and dairy free diet for a year and a half. My sister went on it with me to show support (I went on to boost my immune system for anti-cancer reasons but not for weight and was actually worried that I'd loose weight).

Anyhow - my sister has lost about 30 pounds - in the first 6 months or so - and has easily kept off the weight. For the first time in her life her weight is a non-issue. She is at a normal and healthy weight and happily eats well. Her hair shines and she feels good. By changing her cooking habits her husband lost about 10 pounds without doing a thing different except eating differently for dinner. (guys are lucky like that

. I also feel good on this diet and did not really feel bad before but wanted to follow a UCLA doctor's advice for diet and supplements. My boyfriend (what a stupid term) also follows this diet and he is a single dad of two young ones so it's not too hard to follow if he can do it anyone can.

Whatever you decide to do - please don't let the idiots get you down or take away your own plan to become more healthy!

Flori

BonnieR · 08-20-2008, 04:57 PM

How is it not cancer discrimination if cancer is what disqualified you? I think Gerri made some good suggestions in that regard.
Maybe this all was a blessing in disguise if it is any indication of how the program will be run. It also sounded like it would have been quite a commitment of time and travel.
But it seems they could reimburse your expenses since you did all of that in good faith.
I know my regional medical center has a medically supervised weight loss program. Maybe you have something like that close to you? And I did really well on good old Weight Watchers a few years ago. Lost 30 lbs and kept them off so far. I have also just joined a "Fit After Fifty" exercise program that the medical center offers
Glad you were able to share your frustration with us...keep us posted.

suzan w · 08-20-2008, 05:21 PM

I agree with Bonnie, if that is not breast cancer discrimination, then what is it??? Speaking of type 2 diabetes...my last blood work came back with 'high' (for me) fasting blood sugar of 112. My PCP wants me to ...lose weight (huh? I weigh 120...) watch carbs (does this include ice cream?) and get more exercise...just got a puppy so that is a no-brainer. Really...could any of the breast cancer treatments cause my blood sugar rise??

Jyber · 08-20-2008, 05:56 PM

Thanks for the responses. I am going to write a strong letter to the study director. Perhaps the nurse practitioner was incorrect that the breast cancer disqualifies me - it is NOT among the list of disqualifiers in the material I have.

Suzan, re post above, I was first diagnosed with diabetes while undergoing chemo. Apparently the steroids can wreak havoc with the blood sugar levels and mine really jumped. They are better now but still low diabetic level. My dad had type 2 diabetes and with that history and my weight issue it is a foregone conclusion unless I take action. Thus my motivation.

If this does not work out, I will return to Weight Watchers. But I do think I would bring more long-term commitment to a clinical trial.

Thanks so much for the feedback, all. I do feel better having shared my frustration.

And I DO realize how blessed I am to be dealing with this as my major issue, considering what else I could be dealing with.

Thanks and best wishes to all,
Jyber/Joan

Jyber · 09-04-2008, 10:17 AM

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! :-)

juanita · 09-04-2008, 02:34 PM

I think their reason is pretty silly. Anybody has the potential to develop cancer and have to leave the program. I'm glad they did make some changes.

CLTann · 09-04-2008, 04:01 PM

I fully agree that the late rejection is discrimination. Instead of accepting an e mail apology, send them a bill, including your out of pocket expenses as well as your time wasted on the project at a minimum of $50 per hour.

Gerri · 09-07-2008, 03:39 PM

Jyber,

Sorry that you didn't make it into the trial but happy to hear that you decided to go with Plan B. I just completed my first week of Weight Watchers and lost 6.8 pounds! I have been a member in the past and decided to try the "Core" plan this time around since I was pretty lousy at counting points and writing things down. It was so easy! "Core" is very similar to the way I was already eating - minus the "bad" stuff. I made a few adjustments and got off to a good start. I was worried that my medication would hinder my weight loss but I feel encouraged. I hope you find success with the plan you choose to follow.

Best of luck to you.

Jyber · 09-08-2008, 05:11 AM

Wow, hearty congrats, Gerri! That is very encouraging to hear.

I am planning to start the WW core plan in two weeks (waiting until after a special house guest will have left).

Thanks, all, for the responses.

Jyber/Joan