Pilot Program to Personalize Care & Improve Quality of Life for Women With Ovarian Cancer

H. Lee Moffitt Cancer Center and Research Institute

Status: Completed

Conditions: Ovarian Cancer

Treatments: Other: Post-study Questionnaire; Other: Educational Presentations; Other: CAM Therapies; Other: Pre-study Questionnaire

Study type: Interventional

Funder types: Other

Identifiers

NCT01419210

MCC-15221

Details and patient eligibility

About

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.

Full 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.

Enrollment: 28 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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28 participants in 1 patient group

Complementary and Alternative Medicine (CAM) therapies

Experimental group

Description:

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.

Treatment:

Other: Educational Presentations

Other: CAM Therapies

Other: Post-study Questionnaire

Other: Pre-study Questionnaire