A Trial of a Comprehensive Breast Cancer Treatment Patient Decision Tool

NCT01840163 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 537

Last updated 2018-11-08

Study results available
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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.

Conditions

Interventions

OTHER

Static version of CanSORT tool

OTHER

CanSORT Online Tool

Sponsors & Collaborators

Principal Investigators

  • Sarah T. Hawley, PhD, MPH · University of Michigan

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
84 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-02-28
Primary Completion
2016-08-01
Completion
2017-09-01

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01840163 on ClinicalTrials.gov