Sexual Health and Rehabilitation Online (SHAREonline)

Sexual Health and Rehabilitation Online (SHAREonline): An Educational Intervention for Young Adult Women After Cancer

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Sexual Function Disturbances; Cancer Survivorship
• Intervention / Treatment: Behavioral: Group Session; Behavioral: Coaching Call; Behavioral: Educational Materials

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.

• Study Type: Interventional
• Enrollment (Actual): 84
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Dana Farber Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Behavioral: Group Session; On-line educational session-3 modules-1 hour each for a total of 3 hours; Behavioral: Coaching Call; Single Coaching phone call at one month
Active Comparator: 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	Behavioral: Educational Materials; Individual videoconference session in which participants will receive a pdf of the American Cancer Society booklet, 'Sex and the Adult Female with Cancer

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Outcome Measure	Measure Description	Time Frame
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

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Dana-Farber Cancer Institute
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Sharon Bober, PhD, Dana-Farber Cancer Institute

Study record dates

Study Major Dates

• Study Start (Actual): February 19, 2025
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): May 31, 2027

Study Registration Dates

• First Submitted: June 10, 2024
• First Submitted That Met QC Criteria: June 10, 2024
• First Posted (Actual): June 13, 2024

Study Record Updates

• Last Update Posted (Actual): February 24, 2026
• Last Update Submitted That Met QC Criteria: February 23, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Cancer Survivorship; Sexual Function Disturbances
• Additional Relevant MeSH Terms: Mental Disorders; Sexual Dysfunctions, Psychological
• Other Study ID Numbers: 21-697; R21CA279278 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
• IPD Sharing Time Frame: Data can be shared no earlier than 1 year following the date of publication
• IPD Sharing Access Criteria: Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No