Pilot Program to Personalize Care & Improve Quality of Life for Women With Ovarian Cancer
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|ClinicalTrials.gov Identifier: NCT01419210|
Recruitment Status : Completed
First Posted : August 18, 2011
Last Update Posted : September 24, 2015
|Condition or disease||Intervention/treatment||Phase|
|Ovarian Cancer||Other: Pre-study Questionnaire Other: Educational Presentations Other: CAM Therapies Other: Post-study Questionnaire||Not Applicable|
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 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||28 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||A Pilot Program to Personalize Care by Integrating Traditional and Complementary Medicine for Women With Ovarian Cancer|
|Study Start Date :||January 2010|
|Actual Primary Completion Date :||April 2014|
|Actual Study Completion Date :||September 2015|
Experimental: Complementary and Alternative Medicine (CAM) therapies
This pilot program attends to the need for appropriate patient-centered interventions that integrate CAM with traditional care to maximize both quantity and QOL for women with ovarian cancer.
Other: Pre-study Questionnaire
Assess the interest level for various CAM topics through feedback received from the study participants
Other: Educational Presentations
Attend a two-hour presentation each week for four weeks
Other: CAM Therapies
Integrate the CAM topics of highest interest into participant's regular care
Other: Post-study Questionnaire
Examine the data to see if it supports recommending a larger, multi-site, integrative CAM program for other women with ovarian cancer
- Number of Participants Interested in Complementary and Alternative Medicines (CAM) [ Time Frame: Average of 18 Weeks ]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.
- Contingency Table [ Time Frame: Average of 18 Weeks ]Aim 2, contingency table will be provided to associate pretest factors (e.g., demographics, clinical history, disease status, and psychological status) with the dichotomous outcome of CAM choice.
- Number of Participants Reporting They Were Influenced by the Education Sessions [ Time Frame: Average of 18 Weeks ]Aim 3, symptom experience, quality of life, and knowledge of CAM therapies will be measured pre- and post- CAM education programs. Pre-test means, post-test means, and pre-post difference score means, along with standard deviations, will be calculated. No formal power analysis is planned because this is a pilot study to collect preliminary information for future larger studies.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01419210
|United States, Florida|
|H. Lee Moffitt Cancer Center and Research Institute|
|Tampa, Florida, United States, 33612|
|Principal Investigator:||Robert Wenham, M.D.||H. Lee Moffitt Cancer Center and Research Institute|