Recruiting

Patient Education Materials

Sponsor:

UCLA

Code:

NCT07602374

Conditions

Breast Surgery

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Questionnaires

Video Health Education Materials

Written Health Education Materials

Medical Chart Review

Study Details

Brief summary:

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.

Conditions

Breast Surgery

Study ID

NCT07602374

Start date

Jun 6, 2026

Status verified date

Jun, 2026

Completion date

Mar 31, 2029

Anticipated

Primary completion date

Mar 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

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.

Interventions

Questionnaires

Participants will complete health related questionnaires.

Video Health Education Materials

Five-module video series

Written Health Education Materials

20-page illustrated brochure

Medical Chart Review

Participants may have data collected from the medical record.

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 ]
  • Mean scores on the Preparation for Decision Making (PrepDM) Scale - [ Time Frame: 1 day, during appointment immediately prior to meeting with surgeon ]
  • Mean scores on Reconstruction-Specific Knowledge Quiz [ Time Frame: 1 day, during appointment immediately prior to meeting with surgeon ]

Central Contacts and Locations

Central contacts

Reta Behman, BA

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

Locations

University of California, San Francisco

Recruiting

San Francisco, California, United States, 94143

Contacts

Reta Behnam-Hanona, BA

877-827-3222Reta.Behnam@ucsf.edu

More Information

Sponsor

University of California, San Francisco

Last update posted

Jun 12, 2026

Last verified

Jun, 2026

Keywords

  • Health Education

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, San Francisco on 2026-06-12.