Sexual Therapy and Rehabilitation After Treatment for Ovarian Cancer (START-OC): A Pilot Intervention

Not Applicable

Completed

• Conditions: Ovarian Cancer
• Interventions: Behavioral: Group Session; Behavioral: Telephone Coaching Session; Behavioral: Webinar

• Registration Number: NCT02287519
• Lead Sponsor: Dana-Farber Cancer Institute

Brief Summary

This research study is evaluating an educational intervention for women who have experienced changes in sexual function after treatment for ovarian cancer.

Detailed Description

The purpose of this research is to study the effectiveness of an educational intervention for women who have experienced changes in sexual function after treatment for ovarian cancer. 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 counseling session.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2014-11
• Study First Submitted: 2014-11-04
• Study First Submitted QC: 2014-11-07
• Study First Posted: 2014-11-10
• Primary Completion: 2018-02
• Study Completion: 2019-12
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-27
• Last Update Posted: 2020-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 53

Inclusion Criteria

• Women diagnosed with Stage1-IV ovarian cancer
• Prognosis of at least one year to live (as assessed by provider)
• Endorsement of at least one sexual symptom (see Appendix A for eligibility screening)
• English speaking
• Signed informed consent

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Exclusion Criteria

• History of pelvic radiation
• Cognitive impairment which would interfere with the ability to participate in the study (as assessed by provider)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Support Group	Webinar	* One group educational session will include information on resources, self-help strategies, and relaxation techniques. * One telephone coaching session after the group session Or * Pilot webinar format of the educational session
Support Group	Group Session	* One group educational session will include information on resources, self-help strategies, and relaxation techniques. * One telephone coaching session after the group session Or * Pilot webinar format of the educational session
Support Group	Telephone Coaching Session	* One group educational session will include information on resources, self-help strategies, and relaxation techniques. * One telephone coaching session after the group session Or * Pilot webinar format of the educational session

Primary Outcome Measures

Name	Time	Method
Change in sexual dysfunction will be assessed by change on the Female Sexual Function Index (FSFI).	Baseline, 2 month Post Intervention, 6 Month Post Intervention

Secondary Outcome Measures

Name	Time	Method
Change in sexual self-efficacy will be assessed by change on the Sexual Self-Efficacy Scale	Baseline, 2 Month Post Intervention, 6 Month Post Intervention
Feasibility of conducting a group sexual health intervention via webinar format will be assessed with descriptive data and qualitative feedback from participants	Baseline, 2 Month Post Intervention, 6 Month Post Intervention	To explore and describe women's experience of webinar platform.
Improvement in sexual knowledge will be assessed by change on the Sexual Knowledge after Ovarian Cancer questionnaire	Baseline, 2 Month Post Intervention, 6 Month Post Intervention
Change in psychological distress will be assessed by change on the BSI-18 (Brief Symptom Inventory)	Baseline, 2 Month Post Intervention, 6 Month Post Intervention

Trial Locations

Locations (2)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

Dana Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States