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Completed

NCT Number: NCT03631758

Evaluating the Impact of Evidence-based Information About Mammography 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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

40 year–49 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

McMaster University

Hamilton, Ontario, L8P0A1, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Evidence-based information

Other

Evidence-based information on mammography such as blog posts, plain language evidence summaries and web resource ratings (quality-appraised online resources).

Patient Decision Aid

Behavioral

Patient Decision Aid for breast cancer screening decision

Sham information

Other

Educational information not specific to mammography or cancer screening

Primary outcomes

  1. Decisional Conflict Scale

    Time frame: Change from baseline to 6-mo

    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.

Secondary outcomes

  1. Decision quality

    Time frame: Change from baseline to 6-mo

    Decision Quality Worksheet for Mammography

  2. Preparation for Decision Making Scale

    Time frame: Change from baseline to 6-mo

    A validated scale, items are summed and scored to create a score of 0-100. Higher scores indicate higher preparation for decision making

  3. Screening behaviour

    Time frame: Change from baseline to 6-mo

    Congruency between self-reported screening status and stated decision

Sponsors and collaborators

Lead sponsor

McMaster University

Other

Collaborators

  • Canadian Cancer Society (CCS)

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Aug 15, 2018
Registry last updated
Oct 19, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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