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 — OTHER
    Participants will complete health related questionnaires.
  • Video Health Education Materials — OTHER
    Five-module video series
  • Written Health Education Materials — OTHER
    20-page illustrated brochure
  • Medical Chart Review — OTHER
    Participants 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 Intervention
    On 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 Intervention
    On 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 Intervention
    On 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 Arm
    On 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

Locations (1)

FacilityCityStateZIPSite coordinators
University of California, San FranciscoSan FranciscoCalifornia94143
Reta Behnam-Hanona, BA
877-827-3222

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