Trials / Not Yet Recruiting
Not Yet RecruitingNCT07519200
Sexual Health and Rehabilitation for Women With Metastatic Breast Cancer (SHARE-MC): An Educational Intervention
- Status
- Not Yet Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 96 (estimated)
- Sponsor
- Dana-Farber Cancer Institute · Academic / Other
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
This is a Phase II proof-of-concept investigational study evaluating the SHARE-MC educational intervention designed to address sexual health needs and related adjustment in women with metastatic breast cancer. Participants will be randomized 2:1 to receive either a group education session, or an individual self-management session. the SHARE MC intervention or enhanced usual care. The research study procedures include: screening for eligibility, questionnaires, video conference, educational session, and coaching (as applicable). It is expected that about 96 women will take part in this study. About 64 women will receive the group education session and about 32 will receive the individual self-management session. Participation in this research study is expected to last about 16 weeks.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | SHARE-MC | SHARE-MC educational intervention sessions (plus questionnaires at multiple timepoints), delivered in a single synchronous videoconference via group session with ≤10 participants lasting approximately |
| OTHER | Informational Booklet | Brief (\<20 minutes) individual videoconference session in which participants receive a booklet. |
Timeline
- Start date
- 2026-09-18
- Primary completion
- 2028-11-30
- Completion
- 2028-12-31
- First posted
- 2026-04-09
- Last updated
- 2026-04-09
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT07519200. Inclusion in this directory is not an endorsement.