Sexual Health and Rehabilitation for Women With Metastatic Breast Cancer (SHARE-MC): An Educational Intervention
Dana-Farber Cancer Institute
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.
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.…
Eligibility
- Age range
- 18+ years
- Sex
- Female
- Healthy volunteers
- No
Inclusion Criteria: * 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 Exclusion Criteria: * Diagnosis of any cancer prior to age 18 * Has never been sexually active * Prior participation in Dr. Bob…
Interventions
- BehavioralSHARE-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
- OtherInformational Booklet
Brief (\<20 minutes) individual videoconference session in which participants receive a booklet.
Location
- Dana-Farber Cancer InstituteBoston, Massachusetts