Ovarian Cancer
Conditions
Keywords
Complementary Medicine, Traditional Medicine
Brief summary
The purpose of this study is to find out if complementary and alternative medicines (CAM) should be included with traditional therapy for women with ovarian cancer. Some of the alternative medicines include non-traditional drug and herbal therapies along with dietary and nutritional strategies. Only a few of these alternative medicines have been tested with women with ovarian cancer.
Detailed description
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.
Interventions
OTHERPre-study Questionnaire
Assess the interest level for various CAM topics through feedback received from the study participants
OTHEREducational Presentations
Attend a two-hour presentation each week for four weeks
OTHERCAM Therapies
Integrate the CAM topics of highest interest into participant's regular care
OTHERPost-study Questionnaire
Examine the data to see if it supports recommending a larger, multi-site, integrative CAM program for other women with ovarian cancer
Sponsors
University of South Florida
H. Lee Moffitt Cancer Center and Research Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* A diagnosis of ovarian cancer * An Eastern Cooperative Oncology Group (ECOG) score of 2 or less with a life expectancy of at least 12 months * A patient being treated by a gynecologic oncologist in the Center for Women's Oncology * Ability to read, understand, and sign the informed consent form * Ability to read, write and understand English, which will be the language used in the materials and oral presentations * Willingness to complete pre-test and post-test questionnaires * Willingness to complete brief questionnaires at each session * Willingness to participate in one follow-up telephone interview at 8 weeks after the final session * Willingness to participate in four sessions that take place at Moffitt Cancer Center * Access to transportation, with the ability to travel to and from Moffitt to participate in the sessions
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Interested in Complementary and Alternative Medicines (CAM) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Contingency Table | 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 | 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. |
Countries
United States
Outcome results
None listed