Breast CancerNCT06864754
WashU DIEP Flap Video and Patient Understanding Improvement
A study testing WashU DIEP Flap Video in people with Breast Cancer, run by Washington University School of Medicine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- WashU DIEP Flap Video
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jul 2025to 31 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Scheduled to have DIEP-flap breast reconstruction at Barnes Jewish Hospital
- Speak English
- ≥ 18 years of age
Who cannot join
- Non-English speaking are excluded as the consent, questionnaires, and video are only available in English.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Washington University School of Medicine
St Louis, Missouri, 63110
Justin M Sacks, M.D., MBA, FACS, 314-362-7388, jmsacks@wustl.edu
Justin M Sacks, M.D., MBA, FACS
About this study
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.
- Conditions
- Breast Cancer
- Being tested
- WashU DIEP Flap Video
- Keywords
- Pre-operative anxiety, Patient understanding, Breast reconstruction, DIEP flap
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WashU DIEP Flap VideoOther
Video uses visual cues and graphics to help explain complex procedures in a simplified, comprehensible fashion to patients.
| Study group | Role | What they receive |
|---|---|---|
| WashU DIEP Flap Video | Experimental | At the pre-operative appointment, patients will complete the pre-video survey (~10min) via RedCap, watch the video (~5min), and complete the post-video survey (~10min) via RedCap. During the standard of care follow-up appointment ≤ 30 days after surgery, consented patients will fill out a third survey via RedCap (~5min). Receives: Other: WashU DIEP Flap Video |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in understanding as measured by the Comprehension Assessment
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.
Measured: 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)
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).
Measured: Before video at pre-operative visit, after video at pre-operative visit, and at post-operative visit (estimated to be 3 months)
Secondary outcomes (3)
Appropriate expectation setting as measured by The Patient Education Materials Assessment Tool (PEMAT)
Will be used to assess video quality. Validated scoring will be used (0-12 with higher score meaning better quality).
Measured: 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)
Validated survey which will be used per published scoring guidelines (8-40 with higher score meaning greater acceptability.
Measured: At post-operative visit (estimated to be at 3 months)
Appropriate expectation setting as measured by the Intervention Appropriateness Measure (IAM)
Validated survey which will be used per published scoring guidelines (8-40 with higher score meaning greater appropriateness.
Measured: At post-operative visit (estimated to be at 3 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2025
- Study start18 Jul 2025
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Justin M Sacks, M.D., MBA, FACS, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06864754
- Sponsor's protocol ID
- 202503134
- Status last verified
- Nov 2025
- First submitted
- 3 Mar 2025
- Last updated
- 24 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- WashU DIEP Flap Video and Patient Understanding Improvement
- ClinicalTrials.gov ID
- NCT06864754
- Acronym / sponsor ID
- 202503134
- Conditions
- Breast Cancer
- Keywords
- Pre-operative anxiety, Patient understanding, Breast reconstruction, DIEP flap
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- 18 Jul 2025 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 7 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| WashU DIEP Flap Video | Experimental | Other: WashU DIEP Flap VideoAt the pre-operative appointment, patients will complete the pre-video survey (~10min) via RedCap, watch the video (~5min), and complete the post-video survey (~10min) via RedCap. During the standard of care follow-up appointment ≤ 30 days after surgery, consented patients will fill out a third survey via RedCap (~5min). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Scheduled to have DIEP-flap breast reconstruction at Barnes Jewish Hospital
- Speak English
- ≥ 18 years of age
Key exclusion criteria (1 listed)
- Non-English speaking are excluded as the consent, questionnaires, and video are only available in English.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WashU DIEP Flap VideoVideo uses visual cues and graphics to help explain complex procedures in a simplified, comprehensible fashion to patients. | Other | WashU DIEP Flap Video |
Primary outcome
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)
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)
Time frame: 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).
3 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2025.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Justin M Sacks, M.D., MBA, FACS principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WashU DIEP Flap Video in people with Breast Cancer, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Justin M Sacks, M.D., MBA, FACS (314-362-7388, jmsacks@wustl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2025.