Female Sexual Dysfunction Intervention
TENDRILS: A Multimedia Intervention for Women's Sexual Dysfunction After Cancer
1 other identifier
observational
91
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Oct 2007
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2007
CompletedFirst Submitted
Initial submission to the registry
January 30, 2008
CompletedFirst Posted
Study publicly available on registry
February 13, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2013
CompletedJanuary 9, 2015
October 1, 2013
5.8 years
January 30, 2008
January 7, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Total score on Female Sexual Function Index (FSFI)
Baseline, after the 12-week treatment period, and at 3- and 6-month follow-ups.
Study Arms (3)
Phase I - Focus Groups
Phase II TENDRILS
Phase II - TENDRILS Program only.
Phase II TENDRILS + Counseling
Phase II - TENDRILS + Sexual Counseling Sessions.
Interventions
To evaluate a multimedia intervention program for women with cancer-related sexual dysfunction.
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.
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.
Attend 3 sexual counseling sessions at M. D. Anderson.
Eligibility Criteria
Women, over 18 years old, with cancer-related sexual dysfunction.
You may qualify if:
- Phase I: Woman cancer survivor
- Phase I: Speaks and reads English well enough to evaluate the website and participate in a focus group
- Phase II: Had breast cancer or a gynecological cancer diagnosed 1 to 5 years previously
- Phase II: Has a sexual partner in relationship of at least 6 months' duration.
- 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).
- Phase II: Lives in commuting distance of MDACC so that can attend 3 counseling sessions if randomized to professional treatment group.
- Phase II: Currently no evidence of active cancer.
- Phase II: Not receiving any cancer treatment other than hormonal therapy.
You may not qualify if:
- Phase I: Under age 18
- Phase II: Under age 18
- Phase II: Currently in mental health care for a sexual problem.
- 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.
- Phase II: Cannot arrange for participant to have privacy when accessing internet at home, even if we offer loaner laptop and subsidized internet service.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- M.D. Anderson Cancer Centerlead
- National Cancer Institute (NCI)collaborator
Study Sites (1)
UT MD Anderson Cancer Center
Houston, Texas, 77030, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Leslie R Schover, PhD
M.D. Anderson Cancer Center
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 30, 2008
First Posted
February 13, 2008
Study Start
October 1, 2007
Primary Completion
August 1, 2013
Study Completion
August 1, 2013
Last Updated
January 9, 2015
Record last verified: 2013-10