Sexual Health and Rehabilitation for Women With Metastatic Breast Cancer (SHARE-MC): An Educational Intervention
SHARE-MC
1 other identifier
interventional
96
1 country
1
Brief Summary
This trial will evaluate the SHARE-MC educational intervention designed to address sexual health needs and related adjustment in women with metastatic breast cancer.
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 Sep 2026
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
April 2, 2026
CompletedFirst Posted
Study publicly available on registry
April 9, 2026
CompletedStudy Start
First participant enrolled
September 18, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2028
Study Completion
Last participant's last visit for all outcomes
December 31, 2028
April 9, 2026
April 1, 2026
2.2 years
April 2, 2026
April 2, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Female Sexual Function Index (FSFI) Full-scale Score Change from Baseline
The FSFI is a well-validated 19-item instrument assessing sexual function including lubrication, orgasm, pain and satisfaction. The total sexual function score is the sum of all domain scores, ranging from 2.0 (indicating not sexually active and no desire) to 36.0. A domain score of 0.0 means there was no sexual activity during the past month. Higher scores, both for individual domains and the total score, reflect better sexual functioning.
Up to 8 weeks
Secondary Outcomes (1)
Brief Symptom Inventory (BSI-18) Score Change from Baseline
Up to 8 weeks
Study Arms (2)
Group Education
EXPERIMENTAL64 participants will complete the following: * Baseline visit * 3-hour intervention session - educational modules * 4-week coaching phone call * 8- and 16-week follow-up assessment calls * A subset of participants will complete qualitative interviews
Enhanced Usual Care (Individual Self-Management)
ACTIVE COMPARATOR32 participants will complete the following: * Baseline visit * Individual videoconference session * 4-week coaching phone call * 8-week follow-up assessment call * 8- and 16-week follow-up assessment calls * Subset of participants will complete qualitative interviews
Interventions
SHARE-MC educational intervention sessions (plus questionnaires at multiple timepoints), delivered in a single synchronous videoconference via group session with ≤10 participants lasting approximately
Brief (\<20 minutes) individual videoconference session in which participants receive a booklet.
Eligibility Criteria
You may qualify if:
- Women diagnosed with metastatic breast cancer
- Age ≥ 18
- Functionally appropriate to participate in the intervention, as assessed by 3 functional assessment items from the EQ-5D (see Eligibility Screening, Appendix A)
- Bothered by significant sexual dysfunction as evidenced by a Female Sexual Functioning Index (FSFI) score of ≤26. (See Eligibility Screening, Appendix A)
- Ability to read and write in English
- Regular access to the internet
You may not qualify if:
- Diagnosis of any cancer prior to age 18
- Has never been sexually active
- Prior participation in Dr. Bober's sexual health research studies or workshops; or previous appointments with Dr. Bober through the DFCI Sexual Health Program.
- 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
Study Sites (1)
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sharon Bober
Dana-Farber Cancer Institute
Central Study Contacts
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
April 2, 2026
First Posted
April 9, 2026
Study Start (Estimated)
September 18, 2026
Primary Completion (Estimated)
November 30, 2028
Study Completion (Estimated)
December 31, 2028
Last Updated
April 9, 2026
Record last verified: 2026-04
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 innovations@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.