Sexual Health and Rehabilitation After Ovarian Suppression Treatment

Not Applicable

Completed

• Conditions: Ovarian Suppression Treatment; Breast Cancer Survivors; Sexual Function Disturbances
• Interventions: Behavioral: Group Session; Behavioral: Telephone Booster

• Registration Number: NCT03571841
• Lead Sponsor: Dana-Farber Cancer Institute

Brief Summary

This research study is evaluating an educational intervention for breast cancer survivors who have experienced changes in sexual function after ovarian suppression treatment to reduce the risk of breast cancer recurrence.

Detailed Description

The purpose of this research is to study the effectiveness of an educational intervention for breast cancer survivors who have experienced changes in sexual function after ovarian suppression treatment to reduce the risk of cancer recurrence. 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 coaching session.

* The group educational session will last about 4 hours, and will include information on resources, self-help strategies, and relaxation techniques.

* The telephone coaching session will take place four weeks after the group session, and will last about 15 minutes

Study Timeline

• Study First Submitted: 2018-06-18
• Study First Submitted QC: 2018-06-27
• Study First Posted: 2018-06-28
• Study Start: 2018-12-01
• Primary Completion: 2019-12-01
• Study Completion: 2019-12-01
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-11
• Last Update Posted: 2021-11-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 20

Inclusion Criteria

• Women with a history of breast cancer who are currently on chemical ovarian suppression
• Current age ≤ 50
• No active cancer therapy in the past 6 months and no future therapy planned
• Endorsement of at least one sexual symptom (see Appendix A for eligibility screening)
• English-speaking

Exclusion Criteria

• History of pelvic radiation
• Prior participation in one of Dr. Bober's sexual health workshops

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Educational Intervention	Group Session	For breast cancer survivors currently on chemical ovarian suppression who are experiencing sexual dysfunction. * Group Session * Telephone Booster Session
Educational Intervention	Telephone Booster	For breast cancer survivors currently on chemical ovarian suppression who are experiencing sexual dysfunction. * Group Session * Telephone Booster Session

Primary Outcome Measures

Name	Time	Method
Change in Sexual Function (FSFI)	Paired t-test (Wilcoxon signed-rank test) Baseline to 2 Month Follow-up	Baseline to 2 Month Follow-up Paired t-test (Wilcoxon signed-rank test)

Secondary Outcome Measures

Name	Time	Method
Change in participants psychological distress on Brief Symptom Inventory	Baseline to 2 Months	Paired t-test (Wilcoxon signed-rank test)

Trial Locations

Locations (1)

Dana Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States