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WashU DIEP Flap Video and Patient Understanding Improvement

WashU DIEP Flap Video and Patient Understanding Improvement

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06864754
Enrollment
300
Registered
2025-03-07
Start date
2025-07-18
Completion date
2026-10-31
Last updated
2025-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

Pre-operative anxiety, Patient understanding, Breast reconstruction, DIEP flap

Brief summary

Patients will complete a survey before and after watching the WashU DIEP Flap Video at their pre-operative standard of care visit, and a third survey at their post-operative standard of care visit. These surveys will use questions from SILS, APAIS, PEMAT, and AIM/IAM to assess the patient's health literacy, demographics questions, and questions concerning patient understanding and anxiety surrounding the procedure. The purpose of the post-op survey will be to assess how well the video set expectations of the procedure and recovery process and will repeat questions asked pre-operatively. Survey responses will be analyzed to determine if there are beneficial trends and improvement in patient understanding and anxiety due to adjunct video usage. Primary Objective: The primary aim of the study is to determine if our animated video affects understanding and anxiety survey scores in patients undergoing DIEP breast reconstruction.

Interventions

OTHERWashU DIEP Flap Video

Video uses visual cues and graphics to help explain complex procedures in a simplified, comprehensible fashion to patients.

Sponsors

Washington University School of Medicine
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Scheduled to have DIEP-flap breast reconstruction at Barnes Jewish Hospital * Speak English * ≥ 18 years of age

Exclusion criteria

* Non-English speaking are excluded as the consent, questionnaires, and video are only available in English.

Design outcomes

Primary

MeasureTime frameDescription
Change in understanding as measured by the Comprehension AssessmentBefore video at pre-operative visit, after video at pre-operative visit, and at post-operative visit (estimated to be 3 months)The pre-op, pre-video survey includes a 10-question comprehension assessment. The pre-op, post-video survey repeats the comprehension assessment. Scores of the comprehension assessment will be compared before and after video watching per patient to determine change in understanding due to the video. It will be scored on a 10-point scale based on correct answers with a higher score meaning greater understanding of the procedure.
Change in anxiety as measured by the Amsterdam Preoperative Anxiety and Information Scale (APAIS)Before video at pre-operative visit, after video at pre-operative visit, and at post-operative visit (estimated to be 3 months)Scores of the APAIS will be compared before and after video watching per patient to determine change in anxiety due to the video. Scoring of APAIS will be per the literature (6-30 with higher score meaning greater anxiety).

Secondary

MeasureTime frameDescription
Appropriate expectation setting as measured by The Patient Education Materials Assessment Tool (PEMAT)Before video at pre-operative visit and at post-operative visit (estimated to be 3 months)Will be used to assess video quality. Validated scoring will be used (0-12 with higher score meaning better quality).
Appropriate expectation setting as measured by the Acceptability of Intervention Measure (AIM)At post-operative visit (estimated to be at 3 months)Validated survey which will be used per published scoring guidelines (8-40 with higher score meaning greater acceptability.
Appropriate expectation setting as measured by the Intervention Appropriateness Measure (IAM)At post-operative visit (estimated to be at 3 months)Validated survey which will be used per published scoring guidelines (8-40 with higher score meaning greater appropriateness.

Countries

United States

Contacts

Primary ContactJustin M Sacks, M.D., MBA, FACS
jmsacks@wustl.edu314-362-7388

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026