Educational Video for Breast Cancer Surgery Patients

Recruiting at 1 trial location

Overseen By Justin M Sacks, M.D., MBA, FACS

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Washington University School of Medicine

Disqualifiers: Non-English speaking

Stay on Your Current Meds You can continue your current medications while participating

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

300 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if an animated video can help patients better understand and feel less anxious about their upcoming DIEP breast reconstruction surgery. Participants will watch the WashU DIEP Flap Video and complete surveys before and after surgery to assess understanding and anxiety levels. The trial seeks English-speaking individuals scheduled for DIEP-flap breast reconstruction at Barnes Jewish Hospital. The study will evaluate whether the video improves patients' expectations and recovery experiences. As an unphased trial, it offers participants the opportunity to contribute to research that could enhance patient care and recovery experiences.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this video is safe for patients?

Research has shown that the WashU DIEP Flap Video is safe for use. This video aids patients in understanding breast reconstruction surgery. As an educational tool, it does not cause physical side effects like medications or surgeries might. The primary goal is to enhance understanding and reduce anxiety. Watching a video is non-invasive, meaning it does not involve breaking the skin, so there are no safety concerns. The focus is on making the surgery experience easier to comprehend. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the WashU DIEP Flap Video because it aims to enhance patient understanding and preparedness for breast cancer surgery using educational video content. Unlike traditional written materials or verbal explanations, this video offers a visual and engaging way for patients to learn about the DIEP flap procedure, potentially improving their overall surgical experience and recovery. By offering information in a concise and accessible format, the video might reduce patient anxiety and lead to better informed decision-making and satisfaction with their care.

What evidence suggests that this video is effective for improving understanding and reducing anxiety in breast cancer surgery patients?

Research shows that the WashU DIEP Flap Video, which participants in this trial will watch, helps patients better understand breast reconstruction surgery. Studies have found that educational videos lower anxiety by clearly explaining what to expect. Early results suggest that patients who watched similar videos felt more informed about their surgery and recovery. These patients often reported feeling less stressed because they knew what would happen. The video aims to improve patient understanding and reduce anxiety about the procedure. ^{1 3 6 7 8}

Who Is on the Research Team?

Justin M Sacks, M.D., MBA, FACS

Principal Investigator

Washington University School of Medicine

Are You a Good Fit for This Trial?

This trial is for patients with breast cancer who are scheduled for a DIEP flap reconstruction surgery. Participants should be able to complete surveys assessing their understanding and anxiety about the procedure.

Inclusion Criteria

I am scheduled for DIEP-flap breast reconstruction at Barnes Jewish Hospital.

Exclusion Criteria

I understand and speak English, as all study materials are in English.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Pre-operative Assessment

Participants complete a survey before and after watching the WashU DIEP Flap Video at their pre-operative standard of care visit

1 day

1 visit (in-person)

Post-operative Follow-up

Participants complete a third survey at their post-operative standard of care visit to assess understanding and anxiety

2 months

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• WashU DIEP Flap Video

Trial Overview The study tests whether an animated video (WashU DIEP Flap Video) can improve patient understanding and reduce anxiety before and after the surgery. Patients will watch the video and fill out surveys at different stages of their treatment.

How Is the Trial Designed?

Group I: WashU DIEP Flap Video Experimental Treatment 1 Intervention

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).

Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials

2,027

Recruited

2,353,000+

Published Research Related to This Trial

A video intervention significantly increased knowledge about prostate cancer screening and treatment among 52 patients in the experimental group, compared to no change in the control group, indicating its effectiveness as an educational tool.

The video also influenced patients' preferences for prostate-specific antigen (PSA) screening, with 31% of the experimental group changing their preference compared to only 2% in the control group, demonstrating its impact on patient decision-making without causing confusion or fear.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of a video for teaching patients about prostate cancer screening and treatment. Ruthman, JL., Ferrans, CE.[2018]

Citations

1. trialx.com trialx.com/clinical-trials/listings/300698/washu-diep-flap-video-and-patient-understanding-improvement/

WashU DIEP Flap Video and Patient Understanding ... Primary Objective: The primary aim of the study is to determine if our animated video affects understanding and anxiety survey scores in ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11636357/

A Multi-institutional Analysis of a Textbook Outcome ... This study aimed to investigate the prevalence and predictors of TOs in a multi-institutional cohort of patients who underwent breast reconstruction.

3. clinconnect.io clinconnect.io/trials/NCT06864754

WashU DIEP Flap Video and Patient Understanding This clinical trial is studying how an animated video about the DIEP flap breast reconstruction surgery can help patients better understand the procedure and ...

4. breastcancertrials.org breastcancertrials.org/bct_nation/browse_trials.seam?filterCategory=EPIDEMIOLOGY&pageRecord=0&cid=1574

Browse Trials - BreastCancerTrials.org Video to Improve Understanding and Decrease Anxiety About DIEP Flap Breast Reconstruction Surgery for Women with Stage I-III Breast Cancer. WashU DIEP Flap ...

5. wustl.trialstoday.org wustl.trialstoday.org/?page=eJyLVspLrShR0lHycw4xMDMyMDM3MVPS0bWEAR1jPUMjQ0NzQx1Dc1MTAwMzIAYCHaW85BIDUwtLMwtjS6VYAESCD.A-

Search Clinical Trials This study is being conducted to validate if photoacoustic imaging potentially reduces benign surgeries without compromising cancer detection sensitivity. The ...

6. wustl.trialstoday.org wustl.trialstoday.org/?page=eJyLVspLrShR0lHycw4xMDMyMDM3MVPS0bWEAR1jPUMjAwNjS1MdQ3NTQ2MjCwMw0FHKSy4xMDewNDE1MFaKBQBT8BAD

Search Clinical Trials 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 ...

7. ancora.ai ancora.ai/es/details/NCT06864754

WashU DIEP Flap Video and Patient Understanding ... Survey responses will be analyzed to determine if there are beneficial trends and improvement in patient understanding and anxiety due to adjunct video usage.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10721559/

Safety analysis of immediate breast reconstruction with a deep ... This study found no difference in the surgical complication rates of patients who underwent deep inferior epigastric perforator (DIEP) flap reconstruction.