N/A N=396 Randomized Health Services Research

Implementing BREASTChoice Into Practice

Breast Reconstruction · Breast Cancer

Bottom Line

View on ClinicalTrials.gov: NCT04491591 ↗

Enrolled (actual)

396

Serious AEs

0.0%

Results posted

Aug 2024

Primary outcome: Primary: Knowledge as Measured by Decision Quality Instrument — 66.7; 66.7 score on a scale — p=0.801

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Breast Reconstruction Education and Support Tool (BREASTChoice) (Other); Attention Control Website (Other); Clinician Survey (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: Female
Sponsor: Washington University School of Medicine
Primary completion: Jul 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY Knowledge as Measured by Decision Quality Instrument	66.7; 66.7	0.0302 sig
PRIMARY Preference Concordance	83; 113; 13; 9; 60; 43	0.1336
PRIMARY Decisional Conflict as Measured by the SURE (Sure of Myself; Understand Information; Risk-benefit Ratio; Encouragement) Scale for Decisional Conflict	31; 44; 105; 113	0.308
SECONDARY Compare Number of High-risk Participants From Each Arm Who Chose Breast Reconstruction	8; 11	0.036 sig
SECONDARY Provider Intention to Engage in Shared Decision Making as Measured by the Change in the Mean CPD (Continuing Professional Development)-Reaction Scale	6.40; 6.55; 5.23; 5.18; 6.04; 6.07	—
SECONDARY Knowledge as Measured by Knowledge Questions Developed in Previous Studies	84.7; 66.5	<0.001 sig
SECONDARY Consult Time as Measured by Time Spent With Clinician During the Visit	—	—
SECONDARY Usability as Measured by the System Usability Scale (SUS)	84.6	—
SECONDARY Knowledge as Measured by Decision Quality Instrument	66.7; 66.7	0.0302 sig
SECONDARY Preference Concordance as Measured by the Decision Quality Instrument	83; 113; 13; 9; 54; 43	0.135
SECONDARY Decisional Conflict as Measured by the SURE (Sure of Myself; Understand Information; Risk-benefit Ratio; Encouragement) Scale for Decisional Conflict	31; 44; 105; 113	0.308

Summary

Breast reconstruction after mastectomy is a highly personal decision. Although it can restore quality of life for many, there are numerous risks associated with the procedure. The risk of complications exceeds that of most elective procedures. In past work, a clinical decision support tool, BREASTChoice, with personalized risk information and patient preferences, was created to be used to address these issues. It was modified with extensive stakeholder input and built to be incorporated into electronic health records and patient portals. This randomized control trial will evaluate whether the implementation of BREASTChoice into routine care delivery is more effective than a control website, at improving the quality of reconstruction decisions.

Eligibility Criteria

Inclusion Criteria

18 years of age or older
Diagnosis of incident or recurrent stage 0-III breast carcinoma

Exclusion Criteria

Stage IV breast carcinoma
Histology type besides ductal/lobular carcinoma (e.g. phyllodes, sarcoma - these rare tumors differ in treatment and prognosis)
Prior mastectomy and are seeking delayed breast reconstruction
No malignancy (i.e., considering mastectomy for prophylaxis only)
Cannot give informed consent or use provided study materials due to self-reported or observed cognitive, visual, or emotional barriers

Inclusion Criteria for Clinicians:

-Clinicians who provide breast cancer care within the plastic and reconstructive surgery at Barnes Jewish Hospital, Siteman Cancer Center, Barnes Jewish West County, Christian Hospital North East, and the Stefanie Spielman Comprehensive Breast Center of OSU who provide care for patients considering breast reconstruction after mastectomy

Exclusion Criteria for Clinicians:

-Plastic and reconstructive clinicians working at other breast clinic locations, and surgeons who do provider breast reconstruction care to patients who have undergone a mastectomy due to breast cancer

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04491591). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.