Sexual Therapy and Rehabilitation After Treatment for Ovarian Cancer (START-OC): A Pilot Intervention

Ovarian Cancer Clinical Trial

— START-OC  

Official title:

Sexual Therapy and Rehabilitation After Treatment for Ovarian Cancer (START-OC): A Pilot Intervention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02287519
• Other study ID #: 14-368
• Status: Completed
• Phase: N/A
• Start date: November 2014
• Est. completion date: December 2019

Study information

• Verified date: February 2020
• Source: Dana-Farber Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This research study is evaluating an educational intervention for women who have experienced changes in sexual function after treatment for ovarian cancer.

Description:

The purpose of this research is to study the effectiveness of an educational intervention for women who have experienced changes in sexual function after treatment for ovarian cancer. The aim is to develop an effective intervention to help women manage these changes and restore sexual health and functioning. This study consists of attending a group educational session followed by a one-on-one telephone counseling session.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: December 2019
• Est. primary completion date: February 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Women diagnosed with Stage1-IV ovarian cancer

• Prognosis of at least one year to live (as assessed by provider)

• Endorsement of at least one sexual symptom (see Appendix A for eligibility screening)

• English speaking

• Signed informed consent

Exclusion Criteria:

• History of pelvic radiation

• Cognitive impairment which would interfere with the ability to participate in the study (as assessed by provider)

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Ovarian Cancer
• Ovarian Neoplasms

Intervention

Behavioral:
• Group Session

• Telephone Coaching Session

• Webinar

Locations

Country	Name	City	State
United States	Dana Farber Cancer Institute	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Dana-Farber Cancer Institute	Patty Brisben Foundation For Women's Sexual Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in sexual dysfunction will be assessed by change on the Female Sexual Function Index (FSFI).		Baseline, 2 month Post Intervention, 6 Month Post Intervention
Secondary	Change in sexual self-efficacy will be assessed by change on the Sexual Self-Efficacy Scale		Baseline, 2 Month Post Intervention, 6 Month Post Intervention
Secondary	Improvement in sexual knowledge will be assessed by change on the Sexual Knowledge after Ovarian Cancer questionnaire		Baseline, 2 Month Post Intervention, 6 Month Post Intervention
Secondary	Change in psychological distress will be assessed by change on the BSI-18 (Brief Symptom Inventory)		Baseline, 2 Month Post Intervention, 6 Month Post Intervention
Secondary	Feasibility of conducting a group sexual health intervention via webinar format will be assessed with descriptive data and qualitative feedback from participants	To explore and describe women's experience of webinar platform.	Baseline, 2 Month Post Intervention, 6 Month Post Intervention