Clinical Trials Directory

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

TypeNameDescription
BEHAVIORALSHARE-MCSHARE-MC educational intervention sessions (plus questionnaires at multiple timepoints), delivered in a single synchronous videoconference via group session with ≤10 participants lasting approximately
OTHERInformational BookletBrief (\<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.