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

NCT ID: NCT01419210

Last Updated: 2015-09-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-01-31
• Study Completion Date: 2015-09-30

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.

Conditions

Ovarian Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Pre-study Questionnaire

Intervention Type: OTHER

Assess the interest level for various CAM topics through feedback received from the study participants

Educational Presentations

Intervention Type: OTHER

Attend a two-hour presentation each week for four weeks

CAM Therapies

Intervention Type: OTHER

Integrate the CAM topics of highest interest into participant's regular care

Post-study Questionnaire

Intervention Type: OTHER

Examine the data to see if it supports recommending a larger, multi-site, integrative CAM program for other women with ovarian cancer

Interventions

Pre-study Questionnaire

Assess the interest level for various CAM topics through feedback received from the study participants

Intervention Type: OTHER

Educational Presentations

Attend a two-hour presentation each week for four weeks

Intervention Type: OTHER

CAM Therapies

Integrate the CAM topics of highest interest into participant's regular care

Intervention Type: 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

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of South Florida

OTHER

Sponsor Role: collaborator

H. Lee Moffitt Cancer Center and Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robert Wenham, M.D.

Role: PRINCIPAL_INVESTIGATOR

H. Lee Moffitt Cancer Center and Research Institute

Locations

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, United States

Countries

United States

Other Identifiers

MCC-15221

Identifier Type: -

Identifier Source: org_study_id