Clinical trial · Observational
Female Sexual Dysfunction Intervention
TENDRILS: A Multimedia Intervention for Women's Sexual Dysfunction After Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Sexual Dysfunction | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Focus Group | Behavioral | — | UNRESOLVED |
| Questionnaires | Behavioral | — | UNRESOLVED |
| Sexual Counseling Sessions | Behavioral | — | UNRESOLVED |
| TENDRILS | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- label
- Phase I - Focus Groups
- interventionNames
- Behavioral: Focus Group
- Behavioral: TENDRILS
- Behavioral: Questionnaires
- label
- Phase II TENDRILS
- description
- Phase II - TENDRILS Program only.
- interventionNames
- Behavioral: TENDRILS
- Behavioral: Questionnaires
- label
- Phase II TENDRILS + Counseling
- description
- Phase II - TENDRILS + Sexual Counseling Sessions.
- interventionNames
- Behavioral: TENDRILS
- Behavioral: Questionnaires
- Behavioral: Sexual Counseling Sessions
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available