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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03631758
• Other study ID #: 4352
• Status: Completed
• Phase: N/A
• Start date: January 1, 2019
• Est. completion date: December 1, 2020

Study information

• Verified date: October 2023
• Source: McMaster University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 209
• Est. completion date: December 1, 2020
• Est. primary completion date: January 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 40 Years to 49 Years

Eligibility

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)

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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

Other:
• Sham information
Educational information not specific to mammography or cancer screening

Locations

Country	Name	City	State
Canada	McMaster University	Hamilton	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
McMaster University	Canadian Cancer Society (CCS)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Decision quality	Decision Quality Worksheet for Mammography	Change from baseline to 6-mo
Secondary	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
Secondary	Screening behaviour	Congruency between self-reported screening status and stated decision	Change from baseline to 6-mo