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Female Sexual Dysfunction Intervention

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00614276
First received: January 30, 2008
Last updated: October 9, 2013
Last verified: October 2013
  Purpose

The goal of this psychosocial research study is to learn whether a website program called "Tendrils: Sexual Renewal for Women after Cancer " may help female cancer survivors improve their sex lives when used either as a self-help tool or in combination with brief sexual counseling by a health care professional.

Objectives:

Sexual dysfunction is the most common long-term consequence of cancer treatment, affecting half of survivors of breast and gynecological cancer and many women treated for other cancers. Yet, few women get the help they need for sexual problems. Our primary objective is to develop and evaluate a multimedia intervention program for women with cancer-related sexual dysfunction. Tendrils: A Sexual Renewal Program for Women Surviving Cancer will: 1) explain the causes of cancer-related sexual dysfunction; 2) offer self-help strategies to prevent or overcome problems; 3) advise women on seeking appropriate medical help; and 4) possibly serve as the core of a counseling program, along with a therapist manual. Tendrils is aimed at a wide audience, from newly diagnosed to long-term survivors, across cancer sites. Material will be presented with sensitivity to religious and cultural attitudes about sexuality. Animations will illustrate anatomy and physiology. The software will let women use Tendrils in a variety of formats: over the internet, on a CD-Rom, printed out, or as downloaded digital video or audio on a handheld computer or media player. Video vignettes will illustrate problems and strategies. Five female cancer survivors will host the program, sharing their experiences.


Condition Intervention
Sexual Dysfunction
Behavioral: Focus Group
Behavioral: TENDRILS
Behavioral: Questionnaires
Behavioral: Sexual Counseling Sessions

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: TENDRILS: A Multimedia Intervention for Women's Sexual Dysfunction After Cancer

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Total score on Female Sexual Function Index (FSFI) [ Time Frame: Baseline, after the 12-week treatment period, and at 3- and 6-month follow-ups. ] [ Designated as safety issue: No ]

Enrollment: 91
Study Start Date: October 2007
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Phase I - Focus Groups Behavioral: Focus Group
To evaluate a multimedia intervention program for women with cancer-related sexual dysfunction.
Behavioral: TENDRILS
Tendrils: A Sexual Renewal Program for Women Surviving Cancer - a website designed to give women information about sexual problems related to cancer and its treatment, and the website suggests ways to overcome those problems.
Behavioral: Questionnaires
The questionnaires ask about your background (such as age, education, relationships), your cancer diagnosis and treatment, and the quality of your life in terms of your health, your general emotions, and your sexual function. The questionnaires take about 30-45 minutes to complete.
Phase II TENDRILS
Phase II - TENDRILS Program only.
Behavioral: TENDRILS
Tendrils: A Sexual Renewal Program for Women Surviving Cancer - a website designed to give women information about sexual problems related to cancer and its treatment, and the website suggests ways to overcome those problems.
Behavioral: Questionnaires
The questionnaires ask about your background (such as age, education, relationships), your cancer diagnosis and treatment, and the quality of your life in terms of your health, your general emotions, and your sexual function. The questionnaires take about 30-45 minutes to complete.
Phase II TENDRILS + Counseling
Phase II - TENDRILS + Sexual Counseling Sessions.
Behavioral: TENDRILS
Tendrils: A Sexual Renewal Program for Women Surviving Cancer - a website designed to give women information about sexual problems related to cancer and its treatment, and the website suggests ways to overcome those problems.
Behavioral: Questionnaires
The questionnaires ask about your background (such as age, education, relationships), your cancer diagnosis and treatment, and the quality of your life in terms of your health, your general emotions, and your sexual function. The questionnaires take about 30-45 minutes to complete.
Behavioral: Sexual Counseling Sessions
Attend 3 sexual counseling sessions at M. D. Anderson.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Women, over 18 years old, with cancer-related sexual dysfunction.

Criteria

Inclusion Criteria:

  1. Phase I: Woman cancer survivor
  2. Phase I: Speaks and reads English well enough to evaluate the website and participate in a focus group
  3. Phase II: Had breast cancer or a gynecological cancer diagnosed 1 to 5 years previously
  4. Phase II: Has a sexual partner in relationship of at least 6 months' duration.
  5. Phase II: Has a score on the Female Sexual Function Inventory below the cut-off criterion indicating sexual dysfunction (i.e. less than 26.55 total score).
  6. Phase II: Lives in commuting distance of MDACC so that can attend 3 counseling sessions if randomized to professional treatment group.
  7. Phase II: Currently no evidence of active cancer.
  8. Phase II: Not receiving any cancer treatment other than hormonal therapy.

Exclusion Criteria:

  1. Phase I: Under age 18
  2. Phase II: Under age 18
  3. Phase II: Currently in mental health care for a sexual problem.
  4. Phase II: BSI-18 at study entry indicates high distress and a visit with project staff confirms that the participant is too distressed to benefit safely from the intervention.
  5. Phase II: Cannot arrange for participant to have privacy when accessing internet at home, even if we offer loaner laptop and subsidized internet service.
  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: NCT00614276

Locations
United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Leslie R Schover, PhD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00614276     History of Changes
Other Study ID Numbers: 2006-0340
Study First Received: January 30, 2008
Last Updated: October 9, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Sexual Dysfunction
Cancer-related Sexual Dysfunction
Female Cancer Survivors
Tendrils
Website program
Self-help tool
Sexual counseling
Questionnaires

ClinicalTrials.gov processed this record on November 27, 2014