Sexual Health and Rehabilitation Online (SHAREonline)
- Conditions
- Cancer SurvivorshipSexual Function Disturbances
- Interventions
- Behavioral: Educational MaterialsBehavioral: Group SessionBehavioral: Coaching Call
- Registration Number
- NCT06458049
- Lead Sponsor
- Dana-Farber Cancer Institute
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 84
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description SHAREonline Coaching Call 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 Individual Self Management Educational Materials 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 SHAREonline Group Session 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
- Primary Outcome Measures
Name Time Method Change in Sexual Function 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 Outcome Measures
Name Time Method Study Engagement Rate Baseline to 1 month Measured through study engagement with a benchmark of study engagement greater than or equal to 70% of eligible candidates
Intervention Completion Rate Baseline to 4 months Measured through intervention completion with a benchmark of intervention completion greater than or equal to 60% of eligible candidates
Enrollment Rate Baseline to 1 month Measured through study accrual with a benchmark of enrollment greater than or equal to 40% of eligible candidates
Change in Emotional Distress Baseline to 4 months BSI-18 (Brief Symptom Inventory) The BSI-18 is a well-validated screening measure of psychological distress with subscales measuring anxiety, depression and somatization that is frequently used with oncology populations.
Change in Sexual Function Baseline to 4 months The Female Sexual Function Index (FSFI Full Scale Score), is 19-item instrument which measures sexual function, including desire, orgasm, pain and satisfaction.
Intervention Acceptability Rate Up to 1 month-post intervention Intervention Satisfaction Questionnaire will be assessed using a benchmark mean score of 4
Distress about Sexual Function Baseline to 4 months Sexual Distress Scale-short form (SDS-SF) is a 5-item measure which assesses distress about sexual function.
Sexual Function, Satisfaction and Sexual Inactivity Baseline to 2 months PROMIS Sexual Function and Satisfaction (PROMIS SexFS) is a short screening
Trial Locations
- Locations (1)
Dana Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States