N/A
N=537
A Trial of a Comprehensive Breast Cancer Treatment Patient Decision Tool
Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT01840163 ↗Enrolled (actual)
537
Serious AEs
0.0%
Results posted
Jul 2018
Primary outcome: Primary: Number of Patients With Accurate Knowledge About Risks and Benefits of Treatment Options for Locoregional Breast Cancer. — 148; 105 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Static version of CanSORT tool (Other); CanSORT Online Tool (Other)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- Female
- Sponsor
- University of Michigan
- Primary completion
- Aug 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients With Accurate Knowledge About Risks and Benefits of Treatment Options for Locoregional Breast Cancer. |
148; 105 | — |
| PRIMARY Number of Patients Choosing a Treatment Option for Locoregional Treatment That Was Values Concordant |
180; 197 | — |
| SECONDARY Patient Preparedness Decision Making for Locoregional Treatment. |
3.9; 3.7 | — |
| SECONDARY Patient Deliberation for Locoregional Breast Cancer Treatment. |
3.9; 3.7 | — |
| SECONDARY Patient Subjective Decision Quality for Locoregional Breast Cancer Treatment |
4.5; 4.4 | — |
| SECONDARY Number of Patients With Accurate Knowledge About Risks and Benefits of Systemic Treatment Options for Breast Cancer |
55; 43 | — |
| SECONDARY Patient Preparedness Decision Making for Systemic Treatment |
3.76; 3.61 | — |
| SECONDARY Patient Subjective Decision Quality for Systemic Breast Cancer Treatment |
3.61; 3.76 | — |
Summary
This study examines the impact of an online decision tool for patients with early stage invasive breast cancer. The study is a randomized controlled trial (RCT) of 444 newly diagnosed patients, recruited from multiple surgical practices in two SEER catchment areas. Participants will be randomized to receive either a basic version of a decision tool (similar to existing website with breast cancer information) or an enhanced version (featuring a knowledge building component, a values clarification exercise, and a patient activation module). Our hypothesis is that patients who use the enhanced version of the tool will have greater knowledge of their test and treatment options, have a higher rate of high quality (i.e., informed, preference-concordant) decisions, and report more positive appraisal of the decision-making process.
Eligibility Criteria
Inclusion Criteria
- Stage 1-2 invasive breast cancer diagnosis,
- DCIS
- Ability to read English
Exclusion Criteria
- Male
Data sourced from ClinicalTrials.gov (NCT01840163). 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.