Efficacy of Written Versus Video Patient Education Materials for Postmastectomy Breast Reconstruction
Part of paid clinical trials in San Francisco, California.
- Sponsor
- University of California, San Francisco
- Study ID
- NCT07602374
- Status
- Not Yet Recruiting
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Conditions
- Breast Surgery
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Questionnaires — OTHERParticipants will complete health related questionnaires.
- Video Health Education Materials — OTHERFive-module video series
- Written Health Education Materials — OTHER20-page illustrated brochure
- Medical Chart Review — OTHERParticipants may have data collected from the medical record.
Study Details
This is a prospective, randomized controlled trial evaluating the comparative efficacy of written, video, and combined written and video patient education materials relative to no supplemental education for University of California, San Francisco (UCSF) patients presenting for post-mastectomy breast reconstruction consultation.
Key Dates
- Start date
- Jun 30, 2026
- Status verified
- May 2026
- Primary completion
- Mar 31, 2028
- Completion
- Mar 31, 2029
Study Design
- Enrollment
- 100 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- SUPPORTIVE_CARE
Arms
- Experimental: Written Educational InterventionOn the day of consultation prior to meeting with the plastic surgeon, participants will receive a 20-page illustrated brochure covering the full range of reconstructive options and be asked to complete surveys. Following the appointment, a medical chart review will be conducted.
- Experimental: Video Educational InterventionOn the day of consultation prior to meeting with the plastic surgeon, participants will receive a five-module video series totaling approximately 20 minutes featuring the senior author and will be asked to complete surveys; expected to take no longer than 10 minutes to complete. Following the appointment, a medical chart review will be conducted.
- Experimental: Combined Educational InterventionOn the day of consultation prior to meeting with the plastic surgeon, participants in the combined arm will receive both written and video materials and will be asked to complete surveys. Following the appointment, a medical chart review will be conducted.
- Other: No Supplemental Education / Control ArmOn the day of consultation prior to meeting with the plastic surgeon, participants will be asked to complete surveys. Following the appointment, a medical chart review will be conducted.
Primary Outcome Measure
Mean scores on the Spielberger State-Trait Anxiety Inventory (STAI), State Form [ Time Frame: 1 day, during appointment immediately prior to meeting with surgeon ]
Central Contacts
- Reta Behman, BA877-827-3222
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of California, San Francisco | San Francisco | California | 94143 |
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