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Giving Information on the Risks and Limitations of Mammography Screening (GIRLS)

NCT02914197 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 608

Last updated 2018-03-22

No results posted yet for this study

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.

Conditions

  • Breast Neoplasm

Interventions

OTHER

Full information

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.

Sponsors & Collaborators

  • David Braley and Nancy Gordon Chair in Family Medicine

    collaborator OTHER

  • McMaster University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
47 Years
Max Age
69 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-11-20
Primary Completion
2018-11-30
Completion
2019-11-30

Countries

  • Canada

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02914197 on ClinicalTrials.gov