NCT02660788

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
5,498

participants targeted

Target at P75+ for not_applicable breast-cancer

Timeline
Completed

Started Feb 2013

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

Study Start

First participant enrolled

February 1, 2013

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 18, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 21, 2016

Completed
5.6 years until next milestone

Results Posted

Study results publicly available

September 2, 2021

Completed
Last Updated

September 30, 2021

Status Verified

September 1, 2021

Enrollment Period

10 months

First QC Date

January 18, 2016

Results QC Date

August 21, 2020

Last Update Submit

September 2, 2021

Conditions

Keywords

6-24 months overduescreening mammography

Outcome Measures

Primary Outcomes (1)

  • Percentage of Overdue Women Returning for Screening Mammography

    Percentage of overdue women returning for screening mammography, measured from the date of randomization

    6 months

Study Arms (2)

Control Arm

ACTIVE COMPARATOR

Mail

Other: Standard Reminder Postcard

Family Physician Reminder Letter Arm

EXPERIMENTAL

Mail

Other: Standard Reminder PostcardOther: Family Physician Reminder Letter

Interventions

Control ArmFamily Physician Reminder Letter Arm
Family Physician Reminder Letter Arm

Eligibility Criteria

Age51 Years - 73 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

BC Cancer Agency

Vancouver, British Columbia, V5Z 4E6, Canada

Location

Related Publications (1)

  • Chan EK, Wilson C, Tyldesley S, Olivotto IA, Lai A, Sam J, Harry R, Nichol A. Signed family physician reminder letters to women overdue for screening mammography: A randomized clinical trial. J Med Screen. 2018 Sep;25(3):149-154. doi: 10.1177/0969141317719921. Epub 2017 Nov 20.

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Results Point of Contact

Title
Dr. Alan Nichol
Organization
BC Cancer

Study Officials

  • Alan Nichol, MD

    British Columbia Cancer Agency

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Radiation Oncologist

Study Record Dates

First Submitted

January 18, 2016

First Posted

January 21, 2016

Study Start

February 1, 2013

Primary Completion

December 1, 2013

Study Completion

December 1, 2015

Last Updated

September 30, 2021

Results First Posted

September 2, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations