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Completed

NCT Number: NCT03571841

Sexual Health and Rehabilitation After Ovarian Suppression Treatment

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.

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Key information

Conditions

Breast Cancer Survivors Mental Disorders Ovarian Suppression Treatment Sexual Dysfunctions, Psychological Sexual Function Disturbances

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Group Session

Behavioral

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

Telephone Booster

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.

Primary outcomes

  1. 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)

Secondary outcomes

  1. Change in participants psychological distress on Brief Symptom Inventory

    Time frame: Baseline to 2 Months

    Paired t-test (Wilcoxon signed-rank test)

Sponsors and collaborators

Lead sponsor

Dana-Farber Cancer Institute

Other

Collaborators

  • Howard Cox Fund for Women Assistant Professors

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jun 28, 2018
Registry last updated
Nov 12, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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