Sexual Health and Rehabilitation Online (SHAREonline)
2 other identifiers
interventional
84
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2025
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 10, 2024
CompletedFirst Posted
Study publicly available on registry
June 13, 2024
CompletedStudy Start
First participant enrolled
February 19, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 31, 2027
February 24, 2026
February 1, 2026
2.3 years
June 10, 2024
February 23, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (10)
Change in Emotional Distress
Baseline to 2 month
Change in Sexual Function
Baseline to 4 months
Change in Emotional Distress
Baseline to 4 months
Enrollment Rate
Baseline to 1 month
Intervention Acceptability Rate
Up to 1 month-post intervention
- +5 more secondary outcomes
Other Outcomes (3)
Sexual Self-efficacy
Baseline to 2 months
Sexual Self-efficacy
Baseline to 4 months
Coaching Satisfaction Summary
Up to 1 month post-coaching session
Study Arms (2)
SHAREonline
EXPERIMENTALParticipants 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
ACTIVE COMPARATORBrief individualized session with online and written materials and guidance. All Participants will complete study questionnaires at baseline, 2 months and 4 months post intervention
Interventions
On-line educational session-3 modules-1 hour each for a total of 3 hours
Individual videoconference session in which participants will receive a pdf of the American Cancer Society booklet, 'Sex and the Adult Female with Cancer
Eligibility Criteria
You may not qualify if:
- Has never been sexually active
- Any impairment (e.g., hearing, visual, cognitive) that interferes with the ability to complete all study procedures independently
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Dana-Farber Cancer Institutelead
- National Cancer Institute (NCI)collaborator
Study Sites (1)
Dana Farber Cancer Institute
Boston, Massachusetts, 02215, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sharon Bober, PhD
Dana-Farber Cancer Institute
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
June 10, 2024
First Posted
June 13, 2024
Study Start
February 19, 2025
Primary Completion (Estimated)
May 31, 2027
Study Completion (Estimated)
May 31, 2027
Last Updated
February 24, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- Data can be shared no earlier than 1 year following the date of publication
- Access Criteria
- Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu
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.