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Old 08-20-2008, 01:35 PM   #1
Jyber
Senior Member
 
Join Date: Oct 2007
Location: PA
Posts: 27
rejected from weight-loss study due to previous breast cancer

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!
__________________
diagnosed 1/07;
ER+, PR+, HER-2 +;
4.2 cm. invasive ductal carcinoma;
mastectomy 2/07;
SNB negative :-) ;
chemo (AC, followed by Taxol); herceptin scheduled until 6/08 but stopped 11/07 due to LVEF drop)
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