NCT03631758

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
209

participants targeted

Target at P75+ for not_applicable breast-cancer

Timeline
Completed

Started Jan 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 13, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 15, 2018

Completed
5 months until next milestone

Study Start

First participant enrolled

January 1, 2019

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2020

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

October 19, 2023

Status Verified

October 1, 2023

Enrollment Period

1.1 years

First QC Date

August 13, 2018

Last Update Submit

October 17, 2023

Conditions

Breast Cancer

Keywords

ScreeningMammographyPatient Decision Aid

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Decision quality

    Change from baseline to 6-mo

  • Preparation for Decision Making Scale

    Change from baseline to 6-mo

  • Screening behaviour

    Change from baseline to 6-mo

Study Arms (3)

Experimental: Evidence + PDA

EXPERIMENTAL

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 informationBehavioral: Patient Decision Aid

Evidence only

EXPERIMENTAL

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

Attention control

SHAM COMPARATOR

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

Other: Sham information

Interventions

Evidence-based informationOTHER

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

Evidence onlyExperimental: Evidence + PDA
Patient Decision AidBEHAVIORAL

Patient Decision Aid for breast cancer screening decision

Experimental: Evidence + PDA
Sham informationOTHER

Educational information not specific to mammography or cancer screening

Attention control

Eligibility Criteria

Age40 Years - 49 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • English speaking women, 40-49 years old
  • Residents of British Columbia, Nova Scotia, and Prince Edward Island

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

McMaster University

Hamilton, Ontario, L8P0A1, Canada

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Maureen Dobbins, RN, PhD

    McMaster University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 13, 2018

First Posted

August 15, 2018

Study Start

January 1, 2019

Primary Completion

January 31, 2020

Study Completion

December 1, 2020

Last Updated

October 19, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)