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

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

Detailed Description
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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.

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

Conditions
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Ovarian Cancer

Intervention / Treatment
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* Behavioral: Group Session
* Behavioral: Telephone Coaching Session
* Behavioral: Webinar


Participation Criteria
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Eligibility Criteria
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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 Exclusion Criteria: History of pelvic radiation Cognitive impairment which would interfere with the ability to participate in the study (as assessed by provider)

Ages Eligible for Study
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Minimum Age: 18 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: Support Group<br>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 | Behavioral: Group Session<br> <br> Behavioral: Telephone Coaching Session<br> <br> Behavioral: Webinar<br> <br> |

What is the study measuring?
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Primary Outcome Measures

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| Feasibility of conducting a group sexual health intervention via webinar format will be assessed with descriptive data and qualitative feedback from participants | To explore and describe women's experience of webinar platform. | Baseline, 2 Month Post Intervention, 6 Month Post Intervention |