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NCT Number: NCT07519200

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SHARE-MC

Behavioral

SHARE-MC educational intervention sessions (plus questionnaires at multiple timepoints), delivered in a single synchronous videoconference via group session with ≤10 participants lasting approximately

Informational Booklet

Other

Brief (<20 minutes) individual videoconference session in which participants receive a booklet.

Primary outcomes

  1. Female Sexual Function Index (FSFI) Full-scale Score Change from Baseline

    Time frame: Up to 8 weeks

    The FSFI is a well-validated 19-item instrument assessing sexual function including lubrication, orgasm, pain and satisfaction. The total sexual function score is the sum of all domain scores, ranging from 2.0 (indicating not sexually active and no desire) to 36.0. A domain score of 0.0 means there was no sexual activity during the past month. Higher scores, both for individual domains and the total score, reflect better sexual functioning.

Secondary outcomes

  1. Brief Symptom Inventory (BSI-18) Score Change from Baseline

    Time frame: Up to 8 weeks

    The BSI-18 is a well-validated screen of psychological distress with subscales measuring anxiety, depression and somatization. BSI-18 items are rated on a 5-point, Likert scale: 0- not at all; 1- a little bit; 2- moderately; 3-quite a bit; 4-extremely.

Study contacts

Contact information is provided by the study sponsor or research team.

Sharon Bober

CONTACT

[email protected]

6176326547

Sponsors and collaborators

Lead sponsor

Dana-Farber Cancer Institute

Other

Registry information

Acronym: SHARE-MC

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Apr 9, 2026
Registry last updated
Apr 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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