Trial record 1 of 405 for:    (complementary OR alternative) medicine AND (woman OR women OR female)
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Pilot Program to Personalize Care & Improve Quality of Life for Women With Ovarian Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
University of South Florida
Information provided by (Responsible Party):
H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier:
NCT01419210
First received: August 16, 2011
Last updated: June 13, 2014
Last verified: June 2014
  Purpose

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 Intervention
Ovarian Cancer
Other: Pre-study Questionnaire
Other: Educational Presentations
Other: CAM Therapies
Other: Post-study Questionnaire

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by H. Lee Moffitt Cancer Center and Research Institute:

Primary Outcome Measures:
  • Number of Participants Interested in Complementary and Alternative Medicines (CAM) [ Time Frame: Average of 18 Weeks ] [ Designated as safety issue: No ]
    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:
  • Contingency Table [ Time Frame: Average of 18 Weeks ] [ Designated as safety issue: No ]
    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.

  • Number of Participants Reporting They Were Influenced by the Education Sessions [ Time Frame: Average of 18 Weeks ] [ Designated as safety issue: No ]
    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.


Enrollment: 28
Study Start Date: January 2010
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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 4 weeks and again 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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 two follow-up telephone interviews at 4 and 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01419210

Locations
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
Investigators
Principal Investigator: Robert Wenham, M.D. H. Lee Moffitt Cancer Center and Research Institute
  More Information

Additional Information:
No publications provided

Responsible Party: H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier: NCT01419210     History of Changes
Other Study ID Numbers: MCC-15221
Study First Received: August 16, 2011
Last Updated: June 13, 2014
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on September 18, 2014