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Breast Reconstruction Education and Support Tool (BREASTChoice) for Breast Reconstruction

N/A
Waitlist Available
Led By Mary Politi, Ph.D.
Research Sponsored by Washington University School of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up assessed pre- and post-study (approximately 24 months)
Awards & highlights

Study Summary

This trial will compare whether a website with personalized risk information and patient preferences helps improve quality of reconstruction decisions compared to a control website.

Eligible Conditions
  • Breast Reconstruction
  • Breast Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~assessed pre- and post-study (approximately 24 months)
This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed pre- and post-study (approximately 24 months) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Decisional conflict as measured by the SURE (Sure of myself; Understand information; Risk-benefit ratio; Encouragement) scale for decisional conflict
Knowledge as measured by Decision Quality Instrument
Preference concordance as measured by the Decision Quality Instrument
Secondary outcome measures
Compare number of high-risk participants from each arm who chose breast reconstruction
Consult time as measured by time spent with clinician during the visit
Knowledge as measured by knowledge questions developed in previous studies
+2 more

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: CliniciansExperimental Treatment1 Intervention
Will receive a brief virtual training on how BREASTChoice functions and the features, including placement of the patient tool summary in the electronic health record Will complete pre-post trial survey about shared decision making
Group II: BREASTChoiceExperimental Treatment1 Intervention
After consent, the participant will be randomized Depending on the clinic work-flow, the patient will be sent the link to the BREASTChoice tool by email or MyChart message 1) prior to their visit with the surgeon; 2) at the time of their visit with the surgeon; 3) after the surgeon appointment Will receive an online survey to complete after viewing the BREASTChoice tool assessing socio-demographics, knowledge, health literacy, decisional conflict, patient engagement, health-related quality of life, preferred decision role, and usability of the website. Will pull from the electronic medical record breast cancer diagnosis stage, previous breast cancer surgery and participants' reconstruction decision after enrollment.
Group III: Attention Control WebsiteActive Control1 Intervention
After consent, the participant will be randomized Depending on the clinic work-flow, the patient will be sent the link to the website by email or MyChart message 1) prior to their visit with the surgeon; 2) at the time of their visit with the surgeon; 3) after the surgeon appointment Will receive an online survey to complete after viewing the website assessing socio-demographics, knowledge, preferences, health literacy, decisional conflict, measure of patient engagement, health-related quality of life, preferred decision role, consult time, and usability of the website. Will pull from the electronic medical record breast cancer diagnosis stage, previous breast cancer surgery and participants' reconstruction decision after enrollment.

Find a Location

Who is running the clinical trial?

Washington University School of MedicineLead Sponsor
1,931 Previous Clinical Trials
2,299,297 Total Patients Enrolled
1 Trials studying Breast Reconstruction
19 Patients Enrolled for Breast Reconstruction
Agency for Healthcare Research and Quality (AHRQ)FED
399 Previous Clinical Trials
6,821,936 Total Patients Enrolled
Mary Politi, Ph.D.Principal InvestigatorWashington University School of Medicine
2 Previous Clinical Trials
267 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Implementing BREASTChoice Into Practice
2020. "Implementing BREASTChoice Into Practice". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04491591.
~93 spots leftby Apr 2025
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