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

September 23, 2015 updated by: H. Lee Moffitt Cancer Center and Research Institute

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Tampa, Florida, United States, 33612
        • H. Lee Moffitt Cancer Center and Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Interested in Complementary and Alternative Medicines (CAM)
Time Frame: 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.
Average of 18 Weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Contingency Table
Time Frame: 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.
Average of 18 Weeks
Number of Participants Reporting They Were Influenced by the Education Sessions
Time Frame: 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.
Average of 18 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

H. Lee Moffitt Cancer Center and Research Institute

Collaborators

University of South Florida

Investigators

  • Principal Investigator: Robert Wenham, M.D., H. Lee Moffitt Cancer Center and Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Actual)

April 1, 2014

Study Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

August 16, 2011

First Submitted That Met QC Criteria

August 17, 2011

First Posted (Estimate)

August 18, 2011

Study Record Updates

Last Update Posted (Estimate)

September 24, 2015

Last Update Submitted That Met QC Criteria

September 23, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MCC-15221

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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