A Randomized Trial of Letters From Family Physicians to Encourage Screening Mammography in Overdue Women

September 2, 2021 updated by: Alan Nichol, British Columbia Cancer Agency

A Randomised Study of Screening Mammography Return Rates in Overdue Women Due to Standard Screening Mammography Program of British Columbia (Smpbc) Reminders Versus Reminder Letters Signed by Women's Family Physicians

A randomized, double-blinded study conducted in British Columbia, Canada, where there is a publicly funded, organized screening program and screening mammography is recommended at 24-month intervals. Eligible women aged 51-73 years old and overdue for their screening mammogram by 6-24 months are identified in the database of the Screening Mammography Program of BC (SMPBC). Family physicians are recruited by mail and asked to sign letters to the overdue women in their practices. The overdue women are randomized and mailed either the signed reminder letter and the standard reminder postcard, or the standard reminder postcard alone. The primary endpoint is the proportion of overdue women attending a screening mammogram appointment 6 months after the mailing.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

5498

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 4E6
        • BC Cancer Agency

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

51 years to 73 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

Active family physicians (family physicians, general practitioners or primary care physicians) who have overdue women in their practice that meet the following criteria:

  • Previously been enrolled in the SMPBC and had a previous normal screening mammogram.
  • Have agreed to being contacted for research on the SMPBC questionnaire
  • Are 6-24 months overdue from their last screening mammogram
  • Live in BC
  • Have listed an active family physician as the contact to receive their mammography results

Exclusion Criteria:

  • Family physicians who do not work in primary care
  • Family physicians who do not have overdue women in their practice

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control Arm
Mail
Other: Standard Reminder Postcard
Experimental: Family Physician Reminder Letter Arm
Mail
Other: Standard Reminder Postcard
Other: Family Physician Reminder Letter

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Overdue Women Returning for Screening Mammography
Time Frame: 6 months
Percentage of overdue women returning for screening mammography, measured from the date of randomization
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

British Columbia Cancer Agency

Collaborators

Canadian Breast Cancer Foundation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2013

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

January 18, 2016

First Submitted That Met QC Criteria

January 20, 2016

First Posted (Estimate)

January 21, 2016

Study Record Updates

Last Update Posted (Actual)

September 30, 2021

Last Update Submitted That Met QC Criteria

September 2, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • H12-02832

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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