Phase 1
N=120
Optimizing Decision Making About Breast Reconstruction After Mastectomy: A Patient-Centered Approach
Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT03346161 ↗Enrolled (actual)
120
Serious AEs
0.0%
Results posted
Sep 2019
Primary outcome: Primary: Percent Correct on the Knowledge Measure (Objective Knowledge Score) — 84.6; 59.7 percentage of answers correct
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Usual care American Society of Plastic Surgeons booklet "Breast Reconstruction" (Other); Decision tool (Other); Usual Care Group - Outcome Measures (Other); Decision Group - Outcome Measures (Other); Demographic and Background Questions (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Washington University School of Medicine
- Primary completion
- Oct 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Correct on the Knowledge Measure (Objective Knowledge Score) |
84.6; 59.7 | — |
| PRIMARY Decisional Conflict (SURE Measure) |
2.9; 2.5 | — |
| PRIMARY Decision Process (Decision Quality Index Subscale) |
65.1; 58.2 | — |
| SECONDARY Quality of Life as Measured by the BREAST-Q Questionnaire |
58.5; 57.3; 64.6; 71.2; 79.5; 82.7 | — |
| SECONDARY Gold Standard Shared Decision Making as Measured by the Top collaboRATE Score |
33; 37 | — |
| SECONDARY Patient Activation (PAM) as Measured by the Number of Participants Who Agreed With Each Statement |
55; 59; 57; 58; 56; 50 | — |
| SECONDARY Receipt of Reconstruction |
48; 47; 11; 8; 1; 3 | — |
| SECONDARY Type of Reconstruction |
23; 27; 10; 8; 15; 12 | — |
| SECONDARY Timing of Reconstruction |
45; 47; 3; 0 | — |
| SECONDARY Time Spent on Tool |
26.7 | — |
| SECONDARY Consult Time |
29.9; 30 | — |
| SECONDARY Usability as Measured by the Computer System Usability Questionnaire (CSUQ) |
6.3 | — |
Summary
Although clinical decision tools (CDTs) exist for a variety of treatments, CDTs designed to support personalized breast reconstruction decisions, particularly about type and timing of reconstruction, are lacking. The objective of this proposal is to develop and pilot test a clinical decision tool that provides personalized risk information and reflects patients' preferences and clinical needs.
Eligibility Criteria
- Newly diagnosed or recurrent breast cancer
- Considering a referral or already referred to a plastic surgeon by their surgical oncologist for possible reconstruction
- Considering or completing a mastectomy.
- Does not have known distant metastatic disease (stage IV disease) at the time of recruitment
- Female.
- English-speaking.
- At least 18 years of age.
- Able to understand and willing to sign an IRB-approved written informed consent document.
Data sourced from ClinicalTrials.gov (NCT03346161). 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.