Sexual Health and Rehabilitation for Women With Metastatic Breast Cancer (SHARE-MC): An Educational Intervention
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: SHARE-MC, Informational Booklet.
- Who it may be relevant to
- Registry conditions: Metastatic Breast Cancer. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- 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.
Primary outcome measures
- Female Sexual Function Index (FSFI) Full-scale Score Change from Baseline [Time frame: Up to 8 weeks]
Secondary outcome measures (1)
- Brief Symptom Inventory (BSI-18) Score Change from Baseline [Time frame: Up to 8 weeks]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- Dana-Farber Cancer Institute — Boston
Identifiers
NCT: NCT07519200 · 25-861