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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Breast Cancer

Intervention / Treatment
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* Other: Evidence-based information
* Behavioral: Patient Decision Aid
* Other: Sham information


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 49 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental: Evidence + PDA<br>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<br>* Evidence-based information on mammography such as blog posts, plain language evidence summaries and web resource ratings (quality-appraised online resources).<br>Behavioral: Patient Decision Aid<br>* Patient Decision Aid for breast cancer screening decision<br>|
| Experimental: Evidence only<br>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<br>* Evidence-based information on mammography such as blog posts, plain language evidence summaries and web resource ratings (quality-appraised online resources).<br>|
| Sham Comparator: Attention control<br>Information on how to distinguish high from low-quality health information, not specific to cancer screening or PDAs | Other: Sham information<br>* Educational information not specific to mammography or cancer screening<br>|

What is the study measuring?
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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 |
| --- | --- | --- |
| 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 | 
| Screening behaviour | Congruency between self-reported screening status and stated decision | Change from baseline to 6-mo | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Screening, Mammography, Patient Decision Aid