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 — BEHAVIORAL
    SHARE-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 — OTHER
    Brief (\<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 Education
    64 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

Locations (1)

FacilityCityStateZIPSite coordinators
Dana-Farber Cancer InstituteBostonMassachusetts02215-

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