An interventional study of Evidence-based information and Patient Decision Aid in Breast Cancer, sponsored by McMaster University. Completed at 1 site in Canada. Open to female participants aged 40 Years to 49 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-10-19.
Sponsored by McMaster University · Not applicable, Interventional, and Screening
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.
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.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 209 is above the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →McMaster University is the lead sponsor of 720 studies on the registry; 124 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 2 (33%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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 · Behavioral: Patient Decision Aid
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
Information on how to distinguish high from low-quality health information, not specific to cancer screening or PDAs
Other: Sham information
Evidence-based information on mammography such as blog posts, plain language evidence summaries and web resource ratings (quality-appraised online resources).
Patient Decision Aid for breast cancer screening decision
Educational information not specific to mammography or cancer screening
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.
Time frame: Change from baseline to 6-mo
Decision quality
Decision Quality Worksheet for Mammography
Time frame: 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
Time frame: Change from baseline to 6-mo
Screening behaviour
Congruency between self-reported screening status and stated decision
Time frame: Change from baseline to 6-mo
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.
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