Sexual Health and Rehabilitation Online (SHAREonline)
NCT Number: NCT06458049
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Cancer Survivorship|Sexual Function Disturbances
Interventions: BEHAVIORAL: Group Session|BEHAVIORAL: Coaching Call|BEHAVIORAL: Educational Materials
Sponsor: Dana-Farber Cancer Institute
Collaborators: National Cancer Institute (NCI)
Sex: FEMALE
Age: ADULT
Enrollment: 84
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-09
Completion Date: 2027-05-31
Locations: Dana Farber Cancer Institute, Boston, Massachusetts, 02215, United States

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.

Primary Outcome Measures: Change in Sexual Function, The Female Sexual Function Index (FSFI Full Scale Score), is 19-item instrument which measures sexual function, including desire, orgasm, pain and satisfaction., Baseline to 2 months
Secondary Outcome Measures: Change in Emotional Distress, 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., Baseline to 2 month|Change in Sexual Function, The Female Sexual Function Index (FSFI Full Scale Score), is 19-item instrument which measures sexual function, including desire, orgasm, pain and satisfaction., Baseline to 4 months|Change in Emotional Distress, 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., Baseline to 4 months|Enrollment Rate, Measured through study accrual with a benchmark of enrollment greater than or equal to 40% of eligible candidates, Baseline to 1 month|Intervention Acceptability Rate, Intervention Satisfaction Questionnaire will be assessed using a benchmark mean score of 4, Up to 1 month-post intervention|Study Engagement Rate, Measured through study engagement with a benchmark of study engagement greater than or equal to 70% of eligible candidates, Baseline to 1 month|Intervention Completion Rate, Measured through intervention completion with a benchmark of intervention completion greater than or equal to 60% of eligible candidates, Baseline to 4 months|Distress about Sexual Function, Sexual Distress Scale-short form (SDS-SF) is a 5-item measure which assesses distress about sexual function., Baseline to 2 months|Distress about Sexual Function, Sexual Distress Scale-short form (SDS-SF) is a 5-item measure which assesses distress about sexual function., Baseline to 4 months|Sexual Function, Satisfaction and Sexual Inactivity, PROMIS Sexual Function and Satisfaction (PROMIS SexFS) is a short screening, Baseline to 2 months
Other Outcome Measures: Sexual Self-efficacy, Sexual Self-Efficacy Scale is a 5-item scale developed to measure perceived sexual self-efficacy to address sexual health after cancer., Baseline to 2 months|Sexual Self-efficacy, Sexual Self-Efficacy Scale is a 5-item scale developed to measure perceived sexual self-efficacy to address sexual health after cancer., Baseline to 4 months|Coaching Satisfaction Summary, Brief participant questionnaire to provide feedback about coaching session., Up to 1 month post-coaching session