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Sponsors and Collaborators: |
M.D. Anderson Cancer Center National Cancer Institute (NCI) |
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Information provided by: | M.D. Anderson Cancer Center |
ClinicalTrials.gov Identifier: | NCT00614276 |
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:
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 |
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Sexual Dysfunction |
Behavioral: Focus Group Behavioral: TENDRILS Behavioral: Questionnaires Behavioral: Sexual Counseling Sessions |
Study Type: | Observational |
Study Design: | Case-Only, Prospective |
Official Title: | TENDRILS: A Multimedia Intervention for Women's Sexual Dysfunction After Cancer |
Estimated Enrollment: | 264 |
Study Start Date: | October 2007 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Groups/Cohorts | Assigned Interventions |
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Ph I
Phase I - Focus Groups
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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.
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Ph II TENDRILS
Phase II - TENDRILS Program only.
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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.
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Ph II TENDRILS + Counseling
Phase II - TENDRILS + Sexual Counseling Sessions.
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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.
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
Women, over 18 years old, with cancer-related sexual dysfunction.
Inclusion Criteria:
Exclusion Criteria:
Contact: Leslie R Schover, PhD | 713-745-2681 |
United States, Texas | |
U.T. M.D. Anderson Cancer Center | Recruiting |
Houston, Texas, United States, 77030 | |
Principal Investigator: Leslie R Schover, PhD |
Principal Investigator: | Leslie R Schover, PhD | U.T. M.D. Anderson Cancer Center |
Responsible Party: | U.T. M.D. Anderson Cancer Center ( Leslie Schover, PhD/Professor ) |
Study ID Numbers: | 2006-0340 |
Study First Received: | January 30, 2008 |
Last Updated: | February 19, 2009 |
ClinicalTrials.gov Identifier: | NCT00614276 History of Changes |
Health Authority: | United States: Institutional Review Board |
Sexual Dysfunction Cancer-related Sexual Dysfunction Female Cancer Survivors Tendrils |
Website program Self-help tool Sexual counseling Questionnaires |