Sexual Health and Rehabilitation After Ovarian Suppression Treatment

November 11, 2021 updated by: Sharon Bober, Ph.D, Dana-Farber Cancer Institute

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Dana Farber Cancer Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Educational Intervention

For breast cancer survivors currently on chemical ovarian suppression who are experiencing sexual dysfunction.

  • Group Session
  • Telephone Booster Session
Behavioral: Group Session
The 4-hour group session will be structured around three 60-minute modules and creation of a personal action plan
Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Sexual Function (FSFI)
Time Frame: 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)
Paired t-test (Wilcoxon signed-rank test) Baseline to 2 Month Follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in participants psychological distress on Brief Symptom Inventory
Time Frame: Baseline to 2 Months
Paired t-test (Wilcoxon signed-rank test)
Baseline to 2 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dana-Farber Cancer Institute

Collaborators

Howard Cox Fund for Women Assistant Professors

Investigators

  • Principal Investigator: Sharon Bober, Ph.D, Dana-Farber Cancer Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2018

Primary Completion (Actual)

December 1, 2019

Study Completion (Actual)

December 1, 2019

Study Registration Dates

First Submitted

June 18, 2018

First Submitted That Met QC Criteria

June 27, 2018

First Posted (Actual)

June 28, 2018

Study Record Updates

Last Update Posted (Actual)

November 12, 2021

Last Update Submitted That Met QC Criteria

November 11, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18-140

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Sexual Function Disturbances

Clinical Trials on Group Session

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Suriname

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe