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

Ovarian Cancer Clinical Trial

Official title:

A Pilot Program to Personalize Care by Integrating Traditional and Complementary Medicine for Women With Ovarian Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01419210
• Other study ID #: MCC-15221
• Status: Completed
• Phase: N/A
• First received: August 16, 2011
• Last updated: September 23, 2015
• Start date: January 2010
• Est. completion date: September 2015

Study information

• Verified date: September 2015
• Source: H. Lee Moffitt Cancer Center and Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: September 2015
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Ovarian Cancer
• Ovarian Neoplasms

Intervention

Other:
• Pre-study Questionnaire
Assess the interest level for various CAM topics through feedback received from the study participants
• Educational Presentations
Attend a two-hour presentation each week for four weeks
• CAM Therapies
Integrate the CAM topics of highest interest into participant's regular care
• 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

Locations

Country	Name	City	State
United States	H. Lee Moffitt Cancer Center and Research Institute	Tampa	Florida

Sponsors (2)

Lead Sponsor	Collaborator
H. Lee Moffitt Cancer Center and Research Institute	University of South Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Interested in Complementary and Alternative Medicines (CAM)	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.	Average of 18 Weeks	No
Secondary	Contingency Table	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.	Average of 18 Weeks	No
Secondary	Number of Participants Reporting They Were Influenced by the Education Sessions	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.	Average of 18 Weeks	No

External Links

•   Moffitt Cancer Center Clinical Trials website