Sexual Health and Rehabilitation Online (SHAREonline): An Educational Intervention for Young Adult Women After Cancer
Overview
- Phase
- Not Applicable
- Intervention
- Group Session
- Conditions
- Cancer Survivorship
- Sponsor
- Dana-Farber Cancer Institute
- Enrollment
- 84
- Locations
- 1
- Primary Endpoint
- Change in Sexual Function
- Status
- Active, not recruiting
- Last Updated
- 2 months ago
Overview
Brief Summary
SHAREonline is a study for young female cancer survivors that are experiencing changes in sexual health and function.
The purpose of this research is to compare two brief interventions delivered by videoconference to learn if they help women effectively manage these changes and restore sexual health and functioning.
Detailed Description
The purpose of this research is to compare two brief interventions delivered by videoconference to learn if they help women effectively manage these changes and restore sexual health and functioning. Participants in this study would first complete health questionnaires and then be randomized to take part in one of two types of education sessions delivered by an instructor over videoconference: 1) Group education session or 2) Individual self-management session. About 56 women will receive the group education session and about 28 will receive the individual self-management session. It is expected that about 84 women will take part in this study.
Investigators
Sharon Bober, Ph.D
Principal Investigator
Dana-Farber Cancer Institute
Eligibility Criteria
Inclusion Criteria
- •Female cancer survivors age 19-49
- •Cancer diagnosis (except non-melanoma skin cancer) ≥ 1 year prior
- •Diagnosed with first cancer ≥ age 18
- •No active cancer therapy (excluding chemoprevention) in the past four months, and no further therapy planned
- •Ability to read and write in English
- •Bothered by significant sexual dysfunction as evidenced by a Female Sexual Functioning Index (FSFI) score of ≤
- •Regular access to the internet
Exclusion Criteria
- •Has never been sexually active
- •Any impairment (e.g., hearing, visual, cognitive) that interferes with the ability to complete all study procedures independently
Arms & Interventions
SHAREonline
Participants will receive: * One online group session structured around three 60-minute modules and creation of a personal action plan * Single Coaching phone call at one month * Questionnaires to complete at baseline, 2 and 4 Months
Intervention: Group Session
SHAREonline
Participants will receive: * One online group session structured around three 60-minute modules and creation of a personal action plan * Single Coaching phone call at one month * Questionnaires to complete at baseline, 2 and 4 Months
Intervention: Coaching Call
Individual Self Management
Brief individualized session with online and written materials and guidance. All Participants will complete study questionnaires at baseline, 2 months and 4 months post intervention
Intervention: Educational Materials
Outcomes
Primary Outcomes
Change in Sexual Function
Time Frame: Baseline to 2 months
The Female Sexual Function Index (FSFI Full Scale Score), is 19-item instrument which measures sexual function, including desire, orgasm, pain and satisfaction.
Secondary Outcomes
- Study Engagement Rate(Baseline to 1 month)
- Intervention Completion Rate(Baseline to 4 months)
- Enrollment Rate(Baseline to 1 month)
- Change in Emotional Distress(Baseline to 4 months)
- Change in Sexual Function(Baseline to 4 months)
- Intervention Acceptability Rate(Up to 1 month-post intervention)
- Distress about Sexual Function(Baseline to 4 months)
- Sexual Function, Satisfaction and Sexual Inactivity(Baseline to 2 months)
- Distress about Sexual Function(Baseline to 2 months)
- Change in Emotional Distress(Baseline to 2 month)