Clinical trial NCT06864754: WashU DIEP Flap Video and Patient Understanding Improvement
Official title: WashU DIEP Flap Video and Patient Understanding Improvement
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Breast Cancer
Keywords: Pre-operative anxiety
Patient understanding
Breast reconstruction
DIEP flap
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2025-03-07
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in understanding as measured by the Comprehension Assessment
timeFrame: Before video at pre-operative visit, after video at pre-operative visit, and at post-operative visit (estimated to be 2 months)
measure: Change in anxiety as measured by the Amsterdam Preoperative Anxiety and Information Scale (APAIS)
timeFrame: Before video at pre-operative visit, after video at pre-operative visit, and at post-operative visit (estimated to be 2 months)
Secondary outcomes:
measure: Appropriate expectation setting as measured by The Patient Education Materials Assessment Tool (PEMAT)
timeFrame: Before video at pre-operative visit and at post-operative visit (estimated to be 2 months)
measure: Appropriate expectation setting as measured by the Acceptability of Intervention Measure (AIM)
timeFrame: At post-operative visit (estimated to be at 2 months)
measure: Appropriate expectation setting as measured by the Intervention Appropriateness Measure (IAM)
timeFrame: At post-operative visit (estimated to be at 2 months)
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Justin M Sacks, M.D., MBA, FACS
role: PRINCIPAL_INVESTIGATOR
References: