WashU DIEP Flap Video and Patient Understanding Improvement
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: WashU DIEP Flap Video.
- Who it may be relevant to
- Registry conditions: Breast Cancer. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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
- Other WashU DIEP Flap Video
Video uses visual cues and graphics to help explain complex procedures in a simplified, comprehensible fashion to patients.
Primary outcome measures
- Change in understanding as measured by the Comprehension Assessment [Time frame: Before video at pre-operative visit, after video at pre-operative visit, and at post-operative visit (estimated to be 3 months)]
- Change in anxiety as measured by the Amsterdam Preoperative Anxiety and Information Scale (APAIS) [Time frame: Before video at pre-operative visit, after video at pre-operative visit, and at post-operative visit (estimated to be 3 months)]
Secondary outcome measures (3)
- Appropriate expectation setting as measured by The Patient Education Materials Assessment Tool (PEMAT) [Time frame: Before video at pre-operative visit and at post-operative visit (estimated to be 3 months)]
- Appropriate expectation setting as measured by the Acceptability of Intervention Measure (AIM) [Time frame: At post-operative visit (estimated to be at 3 months)]
- Appropriate expectation setting as measured by the Intervention Appropriateness Measure (IAM) [Time frame: At post-operative visit (estimated to be at 3 months)]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- Washington University School of Medicine — St Louis
Identifiers
NCT: NCT06864754 · 202503134