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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01419210
Recruitment Status : Completed
First Posted : August 18, 2011
Last Update Posted : September 24, 2015
University of South Florida
Information provided by (Responsible Party):
H. Lee Moffitt Cancer Center and Research Institute

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.

Condition or disease Intervention/treatment Phase
Ovarian Cancer Other: Pre-study Questionnaire Other: Educational Presentations Other: CAM Therapies Other: Post-study Questionnaire Not Applicable

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  (Clinical Trial)
Actual Enrollment : 28 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : January 2010
Actual Primary Completion Date : April 2014
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer

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

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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.

  2. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01419210

United States, Florida
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States, 33612
Sponsors and Collaborators
H. Lee Moffitt Cancer Center and Research Institute
University of South Florida
Principal Investigator: Robert Wenham, M.D. H. Lee Moffitt Cancer Center and Research Institute

Additional Information:
Responsible Party: H. Lee Moffitt Cancer Center and Research Institute Identifier: NCT01419210     History of Changes
Other Study ID Numbers: MCC-15221
First Posted: August 18, 2011    Key Record Dates
Last Update Posted: September 24, 2015
Last Verified: September 2015

Keywords provided by H. Lee Moffitt Cancer Center and Research Institute:
Complementary Medicine
Traditional Medicine

Additional relevant MeSH terms:
Ovarian Neoplasms
Neoplasms, Glandular and Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Neoplasms by Histologic Type