A Pilot Program to Personalize Care by Integrating Traditional and Complementary Medicine for Women With Ovarian Cancer
The study will be offered to women with ovarian cancer who are receiving care at the
Gynecologic Oncology Clinic at H. Lee Moffitt Cancer Center. Prospective candidates,
identified via chart review, will receive a mailing that describes and invites them to be
screened for eligibility. Potential participants seen in the clinic will also be approached
and invited to participate.
The informed consent process and pretesting will take place in the clinic, with exceptions
made as needed for women who prefer to complete documents at home.
The intervention, which will consist of four educational CAM sessions, will be held on site
in a private room at Moffitt Cancer Center. Immediately before and after each session, we
will administer a brief on-site pre- and post-test. Upon completion of the intervention,
participants will be asked to complete a post-test on site or at home, depending on their
preference. Follow-up telephone calls will be made to the participants 4 weeks and again at
8 weeks after the last session.
Pre- and post-test measures will focus on quality of life, prior use of CAM therapies, topic
preferences, knowledge gained from the presentations, changed intentions and behaviors
associated with CAM, and satisfaction with the program.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Number of Participants Interested in Complementary and Alternative Medicines (CAM)
Aim 1, proportions of participants who attend the education sessions (with 95% confidence intervals) will be calculated for each of the 5 CAM therapies. Mean (along with SD) score will be calculated for each therapy.
Average of 18 Weeks
Robert Wenham, M.D.
H. Lee Moffitt Cancer Center and Research Institute
United States: Institutional Review Board
|H. Lee Moffitt Cancer Center and Research Institute||Tampa, Florida 33612|