Sexual Health and Rehabilitation for Women With Metastatic Breast Cancer (SHARE-MC): An Educational Intervention
Part of paid clinical trials in Boston, Massachusetts.
- Sponsor
- Dana-Farber Cancer Institute
- Study ID
- NCT07519200
- Status
- Not Yet Recruiting
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Conditions
Eligibility Criteria
- Sex
- FEMALE
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- SHARE-MC — BEHAVIORALSHARE-MC educational intervention sessions (plus questionnaires at multiple timepoints), delivered in a single synchronous videoconference via group session with ≤10 participants lasting approximately
- Informational Booklet — OTHERBrief (\<20 minutes) individual videoconference session in which participants receive a booklet.
Study Details
This trial will evaluate the SHARE-MC educational intervention designed to address sexual health needs and related adjustment in women with metastatic breast cancer.
Key Dates
- Start date
- Sep 18, 2026
- Status verified
- Apr 2026
- Primary completion
- Nov 30, 2028
- Completion
- Dec 31, 2028
Study Design
- Enrollment
- 96 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- SUPPORTIVE_CARE
Arms
- Experimental: Group Education64 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
- Active Comparator: Enhanced Usual Care (Individual Self-Management)32 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
Primary Outcome Measure
Female Sexual Function Index (FSFI) Full-scale Score Change from Baseline [ Time Frame: Up to 8 weeks ]
Central Contacts
- Sharon Bober6176326547
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02215 | - |
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