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

NCT ID: NCT03631758

Last Updated: 2023-10-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

209 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-01

Study Completion Date

2020-12-01

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.

Conditions

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Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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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

Group Type EXPERIMENTAL

Evidence-based information

Intervention Type 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

Intervention Type BEHAVIORAL

Patient Decision Aid for breast cancer screening decision

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

Group Type EXPERIMENTAL

Evidence-based information

Intervention Type OTHER

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

Attention control

Information on how to distinguish high from low-quality health information, not specific to cancer screening or PDAs

Group Type SHAM_COMPARATOR

Sham information

Intervention Type OTHER

Educational information not specific to mammography or cancer screening

Interventions

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Evidence-based information

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

Intervention Type OTHER

Patient Decision Aid

Patient Decision Aid for breast cancer screening decision

Intervention Type BEHAVIORAL

Sham information

Educational information not specific to mammography or cancer screening

Intervention Type OTHER

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)
Minimum Eligible Age

40 Years

Maximum Eligible Age

49 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Canadian Cancer Society (CCS)

OTHER

Sponsor Role collaborator

McMaster University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Maureen Dobbins, RN, PhD

Role: PRINCIPAL_INVESTIGATOR

McMaster University

Locations

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McMaster University

Hamilton, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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4352

Identifier Type: -

Identifier Source: org_study_id

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