Sexual Health and Rehabilitation After Ovarian Suppression Treatment

NCT03571841 | Completed

• 1 other identifier: 18-140
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer Survivors; Sexual Function Disturbances; Ovarian Suppression Treatment

Keywords

Breast Cancer Survivors; Sexual Function Disturbances; Ovarian Suppression Treatment

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change in participants psychological distress on Brief Symptom Inventory

  Baseline to 2 Months

Study Arms (1)

Educational Intervention

EXPERIMENTAL

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

Behavioral: Group Session; Behavioral: Telephone Booster

Interventions

Group Session BEHAVIORAL

The 4-hour group session will be structured around three 60-minute modules and creation of a personal action plan

Educational Intervention

Telephone Booster BEHAVIORAL

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.

Educational Intervention

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Dana-Farber Cancer Institute: lead
• Howard Cox Fund for Women Assistant Professors: collaborator

Study Sites (1)

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Sexual Dysfunctions, Psychological

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Sharon Bober, Ph.D

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prinicipal Investigator

Study Record Dates

• First Submitted: June 18, 2018
• First Posted: June 28, 2018
• Study Start: December 1, 2018
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: November 12, 2021

Record last verified: 2021-11

Locations

US (1)