Clinical trial NCT06458049: Sexual Health and Rehabilitation Online (SHAREonline)
Official title: Sexual Health and Rehabilitation Online (SHAREonline): An Educational Intervention for Young Adult Women After Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cancer Survivorship
Sexual Function Disturbances
Keywords: Cancer Survivorship
Sexual Function Disturbances
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2024-06-13
Enrollment: 84
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility 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 ≤26.
* 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

Primary outcomes:
measure: Change in Sexual Function
timeFrame: Baseline to 2 months
Secondary outcomes:
measure: Change in Emotional Distress
timeFrame: Baseline to 2 month
measure: Change in Sexual Function
timeFrame: Baseline to 4 months
measure: Change in Emotional Distress
timeFrame: Baseline to 4 months
measure: Enrollment Rate
timeFrame: Baseline to 1 month
measure: Intervention Acceptability Rate
timeFrame: Up to 1 month-post intervention
measure: Study Engagement Rate
timeFrame: Baseline to 1 month
measure: Intervention Completion Rate
timeFrame: Baseline to 4 months
measure: Distress about Sexual Function
timeFrame: Baseline to 2 months
measure: Distress about Sexual Function
timeFrame: Baseline to 4 months
measure: Sexual Function, Satisfaction and Sexual Inactivity
timeFrame: Baseline to 2 months
Other outcomes:
measure: Sexual Self-efficacy
timeFrame: Baseline to 2 months
measure: Sexual Self-efficacy
timeFrame: Baseline to 4 months
measure: Coaching Satisfaction Summary
timeFrame: Up to 1 month post-coaching session
Locations:
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Sharon Bober, PhD
role: PRINCIPAL_INVESTIGATOR
References: