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

• Sponsor: British Columbia Cancer Agency (Other)
• Overall Status: Completed
• CT.gov ID: NCT02660788
• Collaborator: Canadian Breast Cancer Foundation (Other)
• Enrollment: 5,498
• Location: 1
• Arms: 2
• Duration (Months): 33.9
• Patients Per Site Per Month: 162

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer	Other: Standard Reminder Postcard; Other: Family Physician Reminder Letter	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 5498 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Care Provider)
• Primary Purpose: Prevention
• Official Title: 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
• Study Start Date: Feb 1, 2013
• Actual Primary Completion Date: Dec 1, 2013
• Actual Study Completion Date: Dec 1, 2015

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Percentage of Overdue Women Returning for Screening Mammography [6 months]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 51 Years to 73 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	BC Cancer Agency	Vancouver	British Columbia	Canada	V5Z 4E6

Sponsors and Collaborators

• British Columbia Cancer Agency
• Canadian Breast Cancer Foundation

Investigators

• Principal Investigator: Alan Nichol, MD, British Columbia Cancer Agency

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Alan Nichol, Radiation Oncologist, British Columbia Cancer Agency
• ClinicalTrials.gov Identifier: NCT02660788
• Other Study ID Numbers: H12-02832
• First Posted: Jan 21, 2016
• Last Update Posted: Sep 30, 2021
• Last Verified: Sep 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Alan Nichol, Radiation Oncologist, British Columbia Cancer Agency: 6-24 months overdue; screening mammography

Study Results

Participant Flow

Recruitment Details	The breast cancer screening program participants were identified by their family physicians
Pre-assignment Detail	Only screenees who had not had a mammogram between identification of potential participants and randomization were randomized.

Arm/Group Title	Control Arm	Family Physician Reminder Letter Arm
Arm/Group Description	Mail Standard Reminder Postcard	Mail Standard Reminder Postcard Family Physician Reminder Letter
Period Title: Overall Study
STARTED	2749	2749
COMPLETED	2749	2749
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Control Arm	Family Physician Reminder Letter Arm	Total
Arm/Group Description	Mail Standard Reminder Postcard	Mail Standard Reminder Postcard Family Physician Reminder Letter	Total of all reporting groups
Overall Participants	2749	2749	5498
Age, Customized (participants) [Number]
Number [participants]	2749 100%	2749 100%	5498 100%
Sex: Female, Male (Count of Participants)
Female	2749 100%	2749 100%	5498 100%
Male	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
Canada	2749 100%	2749 100%	5498 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control Arm	Family Physician Reminder Letter Arm
Arm/Group Description	Mail Standard Reminder Postcard	Mail Standard Reminder Postcard Family Physician Reminder Letter
Measure Participants	2749	2749
Number [percentage of participants]	24.0 0.9%	34.4 1.3%

Adverse Events

Time Frame	6 months
Arm/Group Title	Control Arm		Family Physician Reminder Letter Arm
Arm/Group Description	Mail Standard Reminder Postcard		Mail Standard Reminder Postcard Family Physician Reminder Letter
All Cause Mortality
	Control Arm		Family Physician Reminder Letter Arm
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Control Arm		Family Physician Reminder Letter Arm
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/2749 (0%)		0/2749 (0%)
Other (Not Including Serious) Adverse Events
	Control Arm		Family Physician Reminder Letter Arm
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/2749 (0%)		0/2749 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.