Impact of Pre-Operative Web-based Breast Cancer Information on the Quality of Patient Decision-Making

June 8, 2023 updated by: University of Wisconsin, Madison

A Randomized Controlled Trial Evaluating the Impact of Pre-Operative Web-based Breast Cancer Information on the Quality of Patient Decision-Making

This is a prospective randomized control trial to compare the impact of two different types of pre-operative web-based breast cancer information on the quality of patient decision making. Patients are emailed web-based information prior to the surgical consultation. Outcomes are assess at multiple time points: 1) prior to the surgical consultation, 2) immediately following the consultation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

244

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

  1. >18 years of age
  2. Newly diagnosed stage 0-3 breast cancer
  3. English speaking
  4. Has an email address
  5. No prior recent contact with the breast surgeon

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Web-based decision aid
A commercially available web-based breast cancer surgery decision aid
Other: Web-based decision aid
Patients were randomized to receive links to a commercially available decision aid.
Active Comparator: Standard websites
selected, high-quality standard web-sites
Other: Standard websites
Patients were randomized to receive links to standard, high-quality websites.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Knowledge using the Breast Cancer Decision Quality Instrument
Time Frame: immediately prior to the surgical consultation
immediately prior to the surgical consultation

Secondary Outcome Measures

Outcome Measure
Time Frame
Decisional concordance using the Breast Cancer Decision Quality Instrument
Time Frame: immediately prior to the surgical consultation
immediately prior to the surgical consultation
Perceived communication with the breast surgeon using the Breast Cancer Decision Quality Instrument
Time Frame: following the surgical consultation but prior to the surgery
following the surgical consultation but prior to the surgery
Breast surgeon and staff (nurse, mid-level provider) assessment of how the web-based decision aid versus standard high-quality breast cancer websites influenced their patient interactions, based on Practitioner Opinion Survey
Time Frame: at completion of patient accrual, estimated to be 2 years after initiating study
at completion of patient accrual, estimated to be 2 years after initiating study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Wisconsin, Madison

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 24, 2014

Primary Completion (Actual)

June 28, 2016

Study Completion (Actual)

June 28, 2016

Study Registration Dates

First Submitted

April 3, 2017

First Submitted That Met QC Criteria

April 12, 2017

First Posted (Actual)

April 14, 2017

Study Record Updates

Last Update Posted (Actual)

June 12, 2023

Last Update Submitted That Met QC Criteria

June 8, 2023

Last Verified

January 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013-1500
  • UW13089 (Other Identifier: UWCCC)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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