Impact of Pre-Operative Web-based Breast Cancer Information on the Quality of Patient Decision-Making
Primary Purpose
Breast Cancer, Knowledge, Attitudes, Practice
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Web-based decision aid
Standard websites
Sponsored by
About this trial
This is an interventional supportive care trial for Breast Cancer
Eligibility Criteria
- >18 years of age
- Newly diagnosed stage 0-3 breast cancer
- English speaking
- Has an email address
- No prior recent contact with the breast surgeon
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Web-based decision aid
Standard websites
Arm Description
A commercially available web-based breast cancer surgery decision aid
selected, high-quality standard web-sites
Outcomes
Primary Outcome Measures
Knowledge using the Breast Cancer Decision Quality Instrument
Secondary Outcome Measures
Decisional concordance using the Breast Cancer Decision Quality Instrument
Perceived communication with the breast surgeon using the Breast Cancer Decision Quality Instrument
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
Full Information
NCT ID
NCT03116035
First Posted
April 3, 2017
Last Updated
June 8, 2023
Sponsor
University of Wisconsin, Madison
1. Study Identification
Unique Protocol Identification Number
NCT03116035
Brief Title
Impact of Pre-Operative Web-based Breast Cancer Information on the Quality of Patient Decision-Making
Official Title
A Randomized Controlled Trial Evaluating the Impact of Pre-Operative Web-based Breast Cancer Information on the Quality of Patient Decision-Making
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
April 24, 2014 (Actual)
Primary Completion Date
June 28, 2016 (Actual)
Study Completion Date
June 28, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Knowledge, Attitudes, Practice
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
244 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Web-based decision aid
Arm Type
Active Comparator
Arm Description
A commercially available web-based breast cancer surgery decision aid
Arm Title
Standard websites
Arm Type
Active Comparator
Arm Description
selected, high-quality standard web-sites
Intervention Type
Other
Intervention Name(s)
Web-based decision aid
Intervention Description
Patients were randomized to receive links to a commercially available decision aid.
Intervention Type
Other
Intervention Name(s)
Standard websites
Intervention Description
Patients were randomized to receive links to standard, high-quality websites.
Primary Outcome Measure Information:
Title
Knowledge using the Breast Cancer Decision Quality Instrument
Time Frame
immediately prior to the surgical consultation
Secondary Outcome Measure Information:
Title
Decisional concordance using the Breast Cancer Decision Quality Instrument
Time Frame
immediately prior to the surgical consultation
Title
Perceived communication with the breast surgeon using the Breast Cancer Decision Quality Instrument
Time Frame
following the surgical consultation but prior to the surgery
Title
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
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
>18 years of age
Newly diagnosed stage 0-3 breast cancer
English speaking
Has an email address
No prior recent contact with the breast surgeon
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
29246705
Citation
Tucholka JL, Yang DY, Bruce JG, Steffens NM, Schumacher JR, Greenberg CC, Wilke LG, Steiman J, Neuman HB. A Randomized Controlled Trial Evaluating the Impact of Web-Based Information on Breast Cancer Patients' Knowledge of Surgical Treatment Options. J Am Coll Surg. 2018 Feb;226(2):126-133. doi: 10.1016/j.jamcollsurg.2017.10.024. Epub 2017 Dec 12.
Results Reference
derived
Learn more about this trial
Impact of Pre-Operative Web-based Breast Cancer Information on the Quality of Patient Decision-Making
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