Sexual Health and Rehabilitation Online (SHAREonline)

Dana-Farber Cancer Institute

Status: Enrolling

Conditions: Cancer Survivorship; Sexual Function Disturbances

Treatments: Behavioral: Coaching Call; Behavioral: Group Session; Behavioral: Educational Materials

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06458049

R21CA279278 (U.S. NIH Grant/Contract)

21-697

Details and patient eligibility

About

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.

Full 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.

Enrollment: 84 estimated patients

Sex: Female

Ages: 19 to 49 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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84 participants in 2 patient groups

SHAREonline

Experimental group

Description:

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

Treatment:

Behavioral: Group Session

Behavioral: Coaching Call

Individual Self Management

Active Comparator group

Description:

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

Treatment:

Behavioral: Educational Materials