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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03116035
• Other study ID #: 2013-1500
• Secondary ID: UW13089
• Status: Completed
• Phase: N/A
• Start date: April 24, 2014
• Est. completion date: June 28, 2016

Study information

• Verified date: January 2021
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 244
• Est. completion date: June 28, 2016
• Est. primary completion date: June 28, 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Knowledge, Attitudes, Practice

Intervention

Other:
• Web-based decision aid
Patients were randomized to receive links to a commercially available decision aid.
• Standard websites
Patients were randomized to receive links to standard, high-quality websites.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Wisconsin, Madison

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Knowledge using the Breast Cancer Decision Quality Instrument		immediately prior to the surgical consultation
Secondary	Decisional concordance using the Breast Cancer Decision Quality Instrument		immediately prior to the surgical consultation
Secondary	Perceived communication with the breast surgeon using the Breast Cancer Decision Quality Instrument		following the surgical consultation but prior to the surgery
Secondary	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		at completion of patient accrual, estimated to be 2 years after initiating study