Clinical trial · Interventional
Sexual Health and Rehabilitation for Women With Metastatic Breast Cancer (SHARE-MC): An Educational Intervention
NCT07519200CI-TRIAL-00107745SHARE-MCnot yet recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This trial will evaluate the SHARE-MC educational intervention designed to address sexual health needs and related adjustment in women with metastatic breast cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Informational Booklet | Other | — | UNRESOLVED |
| SHARE-MC | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Group Education
- description
- 64 participants will complete the following: * Baseline visit * 3-hour intervention session - educational modules * 4-week coaching phone call * 8- and 16-week follow-up assessment calls * A subset of participants will complete qualitative interviews
- interventionNames
- Behavioral: SHARE-MC
- type
- ACTIVE_COMPARATOR
- label
- Enhanced Usual Care (Individual Self-Management)
- description
- 32 participants will complete the following: * Baseline visit * Individual videoconference session * 4-week coaching phone call * 8-week follow-up assessment call * 8- and 16-week follow-up assessment calls * Subset of participants will complete qualitative interviews
- interventionNames
- Other: Informational Booklet
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.