MDACC Study Summary 2006-0340

Study Summary
No. 2006-0340:.......Breast; Gynecology......Leslie R. Schover......Behavioral Science

Study Summary Title



Study Summary Number:	2006-0340

Study Title:	TENDRILS: A MULTIMEDIA INTERVENTION FOR WOMEN'S SEXUAL DYSFUNCTION AFTER CANCER

Physician

New Patient Referral



Name:	Leslie R. Schover	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Behavioral Science	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-745-2681 Contact us about clinical trials

General Information



Disease Group:	Breast Gynecology	Supported By:	N/A

Phase of Study:	N/A	Return Visit:	In Phase I, two visits: to view the intervention and attend a focus group. In Phase II, half will have 3 counseling visits and half will have none. However, some women may come to MDACC once to borrow a laptop and get trained in its use.

Treatment Agents:	Behavioral Intervention	Home Care:	Women will view the intervention over the internet at home.

Treatment Loc:	Only at MDACC

Estimated Length of Stay in Houston:	Not applicable


Description/ Intervention:	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.

Study Objectives / Outcomes

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.

Study Status Information



Study Activation / Registration Date:	10/30/2007

IRB Review and Approval Date:	06/12/2006

Study Type:	Behavioral

Recruitment Status:	Closed

Projected Accrual:	N/A

Enrollment Eligibility

If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

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 7 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 totel 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.

Links

Registration Number: NCT00614276
Study Information on Clinical Trials Registry (clinicaltrials.gov)