Educational Intervention for Breast Cancer

(SHARE-MC Trial)

Overseen By Sharon Bober

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Dana-Farber Cancer Institute

Disqualifiers: Cancer before 18, Never sexually active, Others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 11

What You Need to Know Before You Apply

What is the purpose of this trial?

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

Who Is on the Research Team?

Sharon Bober

Principal Investigator

Dana-Farber Cancer Institute

Are You a Good Fit for This Trial?

Inclusion Criteria

Ability to read and write in English

I am 18 years old or older.

Regular access to the internet

Exclusion Criteria

I do not have any impairments that prevent me from completing study tasks on my own.

Prior participation in Dr. Bober's sexual health research studies or workshops; or previous appointments with Dr. Bober through the DFCI Sexual Health Program

Has never been sexually active

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline

Participants complete baseline assessments and initial visits

1 week

1 baseline visit

Intervention

Participants receive either a group education session or an individual self-management session

3 hours

1 intervention session

Coaching

Participants receive a 4-week coaching phone call

4 weeks

1 coaching call

Follow-up

Participants are monitored for safety and effectiveness after intervention

8 weeks

8- and 16-week follow-up assessment calls

What Are the Treatments Tested in This Trial?

Interventions

• SHARE-MC

How Is the Trial Designed?

Group I: Group Education Experimental Treatment 1 Intervention

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

Group II: Enhanced Usual Care (Individual Self-Management) Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Dana-Farber Cancer Institute

Lead Sponsor

Trials

1,128

Recruited

382,000+