Sexual Health and Rehabilitation After Ovarian Suppression Treatment

Breast Cancer Survivors Clinical Trial

Official title:

Sexual Health and Rehabilitation After Ovarian Suppression Treatment (SHARE-OS): An Educational Intervention for Young Breast Cancer Survivors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03571841
• Other study ID #: 18-140
• Status: Completed
• Phase: N/A
• Start date: December 1, 2018
• Est. completion date: December 1, 2019

Study information

• Verified date: November 2021
• 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 breast cancer survivors who have experienced changes in sexual function after ovarian suppression treatment to reduce the risk of breast cancer recurrence.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 1, 2019
• Est. primary completion date: December 1, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer Survivors
• Breast Neoplasms
• Ovarian Suppression Treatment
• Sexual Function Disturbances
• Vision Disorders

Intervention

Behavioral:
• Group Session
The 4-hour group session will be structured around three 60-minute modules and creation of a personal action plan
• Telephone Booster
One month following the group session, women will receive a telephone booster session (<15 minutes). This brief telephone check-in is intended to help women review progress with their individualized action-plan, problem-solve around continuing problems, and plan for maintenance moving forward.

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Dana-Farber Cancer Institute	Howard Cox Fund for Women Assistant Professors

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Sexual Function (FSFI)	Baseline to 2 Month Follow-up Paired t-test (Wilcoxon signed-rank test)	Paired t-test (Wilcoxon signed-rank test) Baseline to 2 Month Follow-up
Secondary	Change in participants psychological distress on Brief Symptom Inventory	Paired t-test (Wilcoxon signed-rank test)	Baseline to 2 Months