Evaluating the Impact of Evidence-based Information About Mammography on Breast Cancer Screening Decisions

McMaster Choices Study: Evaluating the Impact of Cancer Screening Patient Decision Aids on Breast Cancer Screening Decisions

Patient decision aids are tools that help guide individuals through a healthcare-related decision making process. They help users combine evidence-based information and recommendations by a health care provider with their personal needs, values and preferences. Through this project, Dr. Dobbins and her research team will explore whether the use of patient decision aids with high-quality and user-friendly summaries of research evidence, or summaries of research evidence alone, help to improve the quality of decision making by women facing breast cancer screening decisions.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Other: Evidence-based information; Behavioral: Patient Decision Aid; Other: Sham information

Detailed Description

Guidelines for breast screening in Canada are based on low-moderate quality evidence of effectiveness and screening is associated with potential harms. Patient Decision Aids (PDAs) are tools that assist users to understand treatment options, risks and benefits to align decisions with values and preferences. The investigators would now like to know whether use of a PDA alongside evidence-based information provided through the McMaster Optimal Aging Portal, or simply access to evidence-based information alone, can help users to make informed decisions about breast cancer screening in women.

• Study Type: Interventional
• Enrollment (Actual): 209
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada, L8P0A1
      • McMaster University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 49 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• English speaking women, 40-49 years old
• Residents of British Columbia, Nova Scotia, and Prince Edward Island

Exclusion Criteria:

• History of breast cancer or mammography in the last 12 months
• Classified as above-average risk for breast cancer (i.e., known genetic mutation linked to BC; no genetic testing, but a parent, sibling or child with a genetic mutation linked to BC; or received chest wall radiation before age 30)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Evidence only; The same evidence-based information as group 1 (Evidence + PDA), but without the PDA to quantify the effect of accessing evidence through the Portal alone	Other: Evidence-based information; Evidence-based information on mammography such as blog posts, plain language evidence summaries and web resource ratings (quality-appraised online resources).
Sham Comparator: Attention control; Information on how to distinguish high from low-quality health information, not specific to cancer screening or PDAs	Other: Sham information; Educational information not specific to mammography or cancer screening
Experimental: Experimental: Evidence + PDA; Evidence-based information on mammography such as blog posts, plain language evidence summaries and web resource ratings (quality-appraised online resources), plus a blog post on PDAs and the relevant decision aid from the Portal database	Other: Evidence-based information; Evidence-based information on mammography such as blog posts, plain language evidence summaries and web resource ratings (quality-appraised online resources).; Behavioral: Patient Decision Aid; Patient Decision Aid for breast cancer screening decision

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Decisional Conflict Scale	A validated scale in which items are summed and scored to create a total score. Scores range from 0 to 100, with higher scores indicating higher decisional conflict.	Change from baseline to 6-mo

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Screening behaviour	Congruency between self-reported screening status and stated decision	Change from baseline to 6-mo
Decision quality	Decision Quality Worksheet for Mammography	Change from baseline to 6-mo
Preparation for Decision Making Scale	A validated scale, items are summed and scored to create a score of 0-100. Higher scores indicate higher preparation for decision making	Change from baseline to 6-mo

Collaborators and Investigators

• Sponsor: McMaster University
• Collaborators: Canadian Cancer Society (CCS)
• Investigators: Principal Investigator: Maureen Dobbins, RN, PhD, McMaster University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2019
• Primary Completion (Actual): January 31, 2020
• Study Completion (Actual): December 1, 2020

Study Registration Dates

• First Submitted: August 13, 2018
• First Submitted That Met QC Criteria: August 13, 2018
• First Posted (Actual): August 15, 2018

Study Record Updates

• Last Update Posted (Actual): October 19, 2023
• Last Update Submitted That Met QC Criteria: October 17, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Screening; Mammography; Patient Decision Aid
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 4352

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