Pilot Program to Personalize Care & Improve Quality of Life for Women With Ovarian Cancer
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Ovarian Cancer |
Other: Pre-study Questionnaire Other: Educational Presentations Other: CAM Therapies Other: Post-study Questionnaire |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: 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 |
- Number of Participants Interested in Complementary and Alternative Medicines (CAM) [ Time Frame: Average of 18 Weeks ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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.
| Estimated Enrollment: | 20 |
| Study Start Date: | January 2010 |
| Estimated Study Completion Date: | September 2013 |
| Estimated Primary Completion Date: | September 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
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 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts 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 two follow-up telephone interviews at 4 and 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
Contacts and Locations| 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 |
More Information
Additional Information:
No publications provided
| Responsible Party: | H. Lee Moffitt Cancer Center and Research Institute |
| ClinicalTrials.gov Identifier: | NCT01419210 History of Changes |
| Other Study ID Numbers: | MCC-15221 |
| Study First Received: | August 16, 2011 |
| Last Updated: | February 20, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by H. Lee Moffitt Cancer Center and Research Institute:
|
Complementary Medicine Traditional Medicine |
Additional relevant MeSH terms:
|
Ovarian Neoplasms Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Ovarian Diseases Adnexal Diseases |
Genital Diseases, Female Genital Neoplasms, Female Urogenital Neoplasms Endocrine System Diseases Gonadal Disorders |
ClinicalTrials.gov processed this record on May 21, 2013