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Sexual Health and Rehabilitation After Ovarian Suppression Treatment

NCT ID: NCT03571841

Last Updated: 2021-11-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-01

Study Completion Date

2019-12-01

Brief Summary

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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

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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

Conditions

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Breast Cancer Survivors Sexual Function Disturbances Ovarian Suppression Treatment

Keywords

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Breast Cancer Survivors Sexual Function Disturbances Ovarian Suppression Treatment

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Educational Intervention

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

* Group Session
* Telephone Booster Session

Group Type EXPERIMENTAL

Group Session

Intervention Type BEHAVIORAL

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

Telephone Booster

Intervention Type 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.

Interventions

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Group Session

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

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Howard Cox Fund for Women Assistant Professors

UNKNOWN

Sponsor Role collaborator

Dana-Farber Cancer Institute

OTHER

Sponsor Role lead

Responsible Party

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Sharon Bober, Ph.D

Prinicipal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sharon Bober, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Dana-Farber Cancer Institute

Locations

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Dana Farber Cancer Institute

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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18-140

Identifier Type: -

Identifier Source: org_study_id