Sexual Health and Rehabilitation for Women With Metastatic Breast Cancer (SHARE-MC): An Educational Intervention

Sexual Health and Rehabilitation for Women With Metastatic Breast Cancer (SHARE-MC): An Educational Intervention

This trial will evaluate the SHARE-MC educational intervention designed to address sexual health needs and related adjustment in women with metastatic breast cancer.

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.

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. Bober's sexual health research studies or workshops; or previous appointments with Dr. Bober through the DFCI Sexual Health Program.
• Any impairment (e.g., hearing, visual, cognitive) that interferes with the ability to complete all study procedures independently