Sexual Health and Rehabilitation After Ovarian Suppression Treatment

Study Overview
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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

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

Conditions
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Breast Cancer Survivors, Sexual Function Disturbances, Ovarian Suppression Treatment

Intervention / Treatment
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* Behavioral: Group Session
* Behavioral: Telephone Booster


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Educational Intervention<br>For breast cancer survivors currently on chemical ovarian suppression who are experiencing sexual dysfunction. Group Session Telephone Booster Session | Behavioral: Group Session<br>* The 4-hour group session will be structured around three 60-minute modules and creation of a personal action plan<br>Behavioral: Telephone Booster<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast Cancer Survivors, Sexual Function Disturbances, Ovarian Suppression Treatment