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Completed

NCT Number: NCT01419210

Pilot Program to Personalize Care & Improve Quality of Life 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.

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Key information

Conditions

Ovarian Cancer Adnexal Diseases Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Neoplasms Neoplasms by Site Ovarian Diseases Ovarian Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pre-study Questionnaire

Other

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

Educational Presentations

Other

Attend a two-hour presentation each week for four weeks

CAM Therapies

Other

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

Post-study Questionnaire

Other

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

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

H. Lee Moffitt Cancer Center and Research Institute

Other

Collaborators

  • University of South Florida

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2014
Study completion
2015
First posted
Aug 18, 2011
Registry last updated
Sep 24, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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