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Sexual Health and Rehabilitation After Ovarian Suppression Treatment

Primary Purpose

Breast Cancer Survivors, Sexual Function Disturbances, Ovarian Suppression Treatment

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Group Session

Telephone Booster

About this trial

This is an interventional supportive care trial for Breast Cancer Survivors focused on measuring Breast Cancer Survivors, Sexual Function Disturbances, Ovarian Suppression Treatment

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Dana Farber Cancer Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Educational Intervention

Arm Description

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

Outcomes

Primary Outcome Measures

Change in Sexual Function (FSFI)

Baseline to 2 Month Follow-up Paired t-test (Wilcoxon signed-rank test)

Secondary Outcome Measures

Change in participants psychological distress on Brief Symptom Inventory

Paired t-test (Wilcoxon signed-rank test)

Full Information

NCT ID

NCT03571841

First Posted

June 18, 2018

Last Updated

November 11, 2021

Sponsor

Dana-Farber Cancer Institute

Collaborators

Howard Cox Fund for Women Assistant Professors

1. Study Identification

Unique Protocol Identification Number

NCT03571841

Brief Title

Sexual Health and Rehabilitation After Ovarian Suppression Treatment

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2021

Overall Recruitment Status

Completed

Study Start Date

December 1, 2018 (Actual)

Primary Completion Date

December 1, 2019 (Actual)

Study Completion Date

December 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Dana-Farber Cancer Institute

Collaborators

Howard Cox Fund for Women Assistant Professors

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer Survivors, Sexual Function Disturbances, Ovarian Suppression Treatment

Keywords

Breast Cancer Survivors, Sexual Function Disturbances, Ovarian Suppression Treatment

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Educational Intervention

Arm Type

Experimental

Arm Description

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

Intervention Type

Behavioral

Intervention Name(s)

Group Session

Intervention Description

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

Intervention Type

Behavioral

Intervention Name(s)

Telephone Booster

Intervention Description

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.

Primary Outcome Measure Information:

Title

Change in Sexual Function (FSFI)

Description

Baseline to 2 Month Follow-up Paired t-test (Wilcoxon signed-rank test)

Time Frame

Paired t-test (Wilcoxon signed-rank test) Baseline to 2 Month Follow-up

Secondary Outcome Measure Information:

Title

Change in participants psychological distress on Brief Symptom Inventory

Description

Paired t-test (Wilcoxon signed-rank test)

Time Frame

Baseline to 2 Months

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sharon Bober, Ph.D

Organizational Affiliation

Dana-Farber Cancer Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

Dana Farber Cancer Institute

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02215

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Sexual Health and Rehabilitation After Ovarian Suppression Treatment

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