Female Sexual Dysfunction Intervention - Full Text View

Purpose

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

MedlinePlus related topics:

Cancer

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case-Only, Prospective

Official Title:	TENDRILS: A Multimedia Intervention for Women's Sexual Dysfunction After Cancer

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

Primary Outcome Measures:

The goal of this psychosocial research study is to see whether a website program called "Tendrils: Sexual Renewal for Women after Cancer" may help female cancer survivors to improve their sex lives. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To learn whether "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. [ Time Frame: 2 Years ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	264
Study Start Date:	October 2007
Estimated Primary Completion Date:	October 2009 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
Ph I 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.
Ph 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.
Ph 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 with cancer-related sexual dysfunction.

Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00614276

Contacts


Contact: Leslie R Schover, PhD	713-745-2681

Locations


United States, Texas
	U.T. M.D. Anderson Cancer Center	Recruiting
	Houston, Texas, United States, 77030
	Principal Investigator: Leslie R Schover, PhD

Sponsors and Collaborators

M.D. Anderson Cancer Center

National Cancer Institute (NCI)

Investigators


Principal Investigator:	Leslie R Schover, PhD	U.T. M.D. Anderson Cancer Center

More Information

Related Info This link exits the ClinicalTrials.gov site

Responsible Party:	U.T. M.D. Anderson Cancer Center ( Leslie Schover, PhD/Professor )
Study ID Numbers:	2006-0340
First Received:	January 30, 2008
Last Updated:	September 19, 2008
ClinicalTrials.gov Identifier:	NCT00614276
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

ClinicalTrials.gov processed this record on October 10, 2008

Sponsors and Collaborators:	M.D. Anderson Cancer Center National Cancer Institute (NCI)
Information provided by:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00614276