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NCT01840163 · ClinicalTrials.gov registry record · NA
A Trial of a Comprehensive Breast Cancer Treatment Patient Decision Tool
A NA study, sponsored by University of Michigan.
- Completed
- Registry status
- NA
- Development phase
- 537
- Enrollment target
NCT01840163: Completed NA study, sponsored by University of Michigan.
NCT01840163 is a NA study that has completed, run by University of Michigan. The registered enrollment target is 537 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (62% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01840163, a NA study, has completed, sponsored by University of Michigan.
- COMPLETED
- Registry status
- NA
- Development phase
- 537 participants
- Enrollment target
Study 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.
Primary Outcome
Self reported knowledge about locoregional treatment using a 5 item Breast Cancer Knowledge Measure (adapted). A binary knowledge indicator was created for all patients whereby high knowledge indicated for patients scoring greater than 80% on the item scale. The binary knowledge variable was analyzed for intervention effect using both unadjusted and adjusted logistic mixed model regression.
Interventions
- OTHER Static version of CanSORT tool
- OTHER CanSORT Online Tool
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 537 participants |
| Start Date | 2014-02 |
| Est. Completion | 2017-09-01 |
| Phase | NA |
What the finished NCT01840163 record still lists
NCT01840163 is an interventional study that assigns participants to a tested intervention. The registered 537 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (62% lower).
The record links to 0 conditions, and to 2 interventions - of which Static version of CanSORT tool is the first listed.
NCT01840163 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01840163 about?
NCT01840163 is a clinical study titled "A Trial of a Comprehensive Breast Cancer Treatment Patient Decision Tool". 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...
What is the current status of trial NCT01840163?
This trial is currently completed. It is a NA study. The enrollment target is 537 participants. The study started on 2014-02. Estimated completion is 2017-09-01.
What interventions are being tested in trial NCT01840163?
The interventions under investigation include: Static version of CanSORT tool (OTHER), CanSORT Online Tool (OTHER).
Who is sponsoring clinical trial NCT01840163?
This trial is sponsored by University of Michigan, which has 1,327 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01840163's enrollment target sits among peer trials
537 188th of 2000 higher than 1,813 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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