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Sexual Health and Rehabilitation After Ovarian Suppression Treatment

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03571841
Enrollment
20
Registered
2018-06-28
Start date
2018-12-01
Completion date
2019-12-01
Last updated
2021-11-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer Survivors, Ovarian Suppression Treatment, Sexual Function Disturbances

Keywords

Breast Cancer Survivors, Sexual Function Disturbances, Ovarian Suppression Treatment

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

Interventions

BEHAVIORALGroup Session

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

BEHAVIORALTelephone 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.

Sponsors

Howard Cox Fund for Women Assistant Professors
CollaboratorUNKNOWN
Dana-Farber Cancer Institute
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in Sexual Function (FSFI)Paired t-test (Wilcoxon signed-rank test) Baseline to 2 Month Follow-upBaseline to 2 Month Follow-up Paired t-test (Wilcoxon signed-rank test)

Secondary

MeasureTime frameDescription
Change in participants psychological distress on Brief Symptom InventoryBaseline to 2 MonthsPaired t-test (Wilcoxon signed-rank test)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026