NCT02914197

Brief Summary

To trial the provision of full information on the benefits and risks of mammography in women that are eligible for breast screening. The knowledge many women have of mammography is not reflective of the recent change in evidence; it is often missing information on over-diagnosis and over-detection. Women tend to overestimate their risk of breast cancer and the benefits of breast screening. In addition, universal breast screening programs are biased towards emphasizing screening. However, a mammogram is not a perfect test and there is no right or wrong decision about whether to have a screening mammogram. It is an individual woman's decision to make. To understand the effect of changing information to reflect the potential for over-diagnosis and over-treatment, we will carry out a pragmatic controlled trial of implementation of balanced information on mammography in family practice.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
608

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

September 22, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 26, 2016

Completed
1.2 years until next milestone

Study Start

First participant enrolled

November 20, 2017

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2019

Completed
Last Updated

March 22, 2018

Status Verified

August 1, 2017

Enrollment Period

12 months

First QC Date

September 22, 2016

Last Update Submit

March 20, 2018

Conditions

Breast Neoplasm

Keywords

DecisionMammographyInformed ChoiceFull InformationDecision AidSelf-efficacyShared decision makingOver-detectionOver-diagnosis

Outcome Measures

Primary Outcomes (1)

  • Self-efficacy

    Decision Self-Efficacy Scale

    1 month

Secondary Outcomes (12)

  • Informed Choice (Knowledge)

    1 month

  • Informed Choice (Attitude)

    1 month

  • Informed Choice (Intention)

    1 month

  • Decisional Conflict

    1 month

  • Anxiety

    1 month

  • +7 more secondary outcomes

Study Arms (2)

Full information

EXPERIMENTAL

The intervention arm will receive full information on the risks and benefits of mammography through: 1. Decision aid 2. YouTube video 3. Group information session

Other: Full information

Control

NO INTERVENTION

Standard information leaflet for breast screening from Cancer Care Ontario

Interventions

Full informationOTHER

Patients will be randomized to receive full information or standard information at the study start. The second wave will follow the same randomization process 6 months following the study start.

Full information

Eligibility Criteria

Age47 Years - 69 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient on the active roster of physicians of MUSIC (McMaster University Sentinel and Information Collaboration; McMaster Family Health Team).
  • Due for a mammogram (have not had a mammogram ≥ 18 months) according to Canadian screening interval recommendations for routine screening.

You may not qualify if:

  • Previous history of invasive or non-invasive breast cancer.
  • At higher risk for breast cancer compared to the general population i.e. identified as having the BRCA1 or BRCA2 gene, immediate family member has had breast cancer.
  • Have had a mammogram within the last 18 months (\< 18 months).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

McMaster University, Department of Family Medicine

Hamilton, Ontario, L8P1H6, Canada

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Central Study Contacts

Dee Mangin, MBChB, DPH, FRNZCGP

CONTACT

905-525-9140mangind@mcmaster.ca

Jessica Langevin, MPH

CONTACT

905-525-9140langevjn@mcmaster.ca

Study Design

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

Study Record Dates

First Submitted

September 22, 2016

First Posted

September 26, 2016

Study Start

November 20, 2017

Primary Completion

November 1, 2018

Study Completion

November 1, 2019

Last Updated

March 22, 2018

Record last verified: 2017-08

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)