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Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Adults aged 18 or older - Presenting as a new patient to the UCSF plastic surgery breast reconstruction clinic - Considering mastectomy, including: - - Therapeutic mastectomy in the setting of a breast cancer diagnosis - - Prophylactic mastectomy in the setting of a confirmed high-risk genetic variant - - Staged procedures, including delayed mastectomy with initial reduction - Participants who are undecided between lumpectomy and mastectomy

Exclusion Criteria

  • Established patients returning for follow-up, in order to minimize confounding variables of individual surgeon education style on outcome measures - Participants who are primarily considering lumpectomy or oncoplastic reduction at the time of their visit - Non-English speakers, as educational materials are currently available in English only

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Supportive Care
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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.
  • Other: Questionnaires
    Participants will complete health related questionnaires.
    Other names:
    • Surveys
  • Other: Written Health Education Materials
    20-page illustrated brochure
    Other names:
    • Health Education Materials
  • Other: Medical Chart Review
    Participants may have data collected from the medical record.
    Other names:
    • Chart Review
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.
  • Other: Questionnaires
    Participants will complete health related questionnaires.
    Other names:
    • Surveys
  • Other: Video Health Education Materials
    Five-module video series
    Other names:
    • Health Education Materials
  • Other: Medical Chart Review
    Participants may have data collected from the medical record.
    Other names:
    • Chart Review
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: Questionnaires
    Participants will complete health related questionnaires.
    Other names:
    • Surveys
  • Other: Video Health Education Materials
    Five-module video series
    Other names:
    • Health Education Materials
  • Other: Written Health Education Materials
    20-page illustrated brochure
    Other names:
    • Health Education Materials
  • Other: Medical Chart Review
    Participants may have data collected from the medical record.
    Other names:
    • Chart Review
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.
  • Other: Questionnaires
    Participants will complete health related questionnaires.
    Other names:
    • Surveys
  • Other: Medical Chart Review
    Participants may have data collected from the medical record.
    Other names:
    • Chart Review

Recruiting Locations

University of California, San Francisco
San Francisco, California 94143
Contact:
Reta Behnam-Hanona, BA
877-827-3222
Reta.Behnam@ucsf.edu

More Details

Status
Recruiting
Sponsor
University of California, San Francisco

Study Contact

Reta Behman, BA
877-827-3222
Reta.Behman@ucsf.edu

Detailed Description

PRIMARY OBJECTIVES: 1. Assess baseline knowledge, procedural confidence, and anxiety in patients presenting for breast reconstruction consultation. 2. Compare post-intervention outcomes between patients receiving written, video, or combined educational materials relative to no supplemental education. SECONDARY OBJECTIVES 1. Examine whether the relative efficacy of each modality differs across patient subgroups defined by age, area deprivation index score, and prior health literacy. OUTLINE: Participants will be randomized into 1 of 4 groups: 1. Written educational intervention 2. Video educational intervention 3. Combined written and video educational intervention 4. No additional educational intervention Outcome measures are assessed at a single timepoint following participant review of assigned materials and prior to the clinical consultation. Enrolled participants who do not review their assigned educational materials prior to the clinical consultation will be excluded from primary analysis but will be included in secondary intent-to-treat analysis

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.