Testing a Behavioural Approach to Improving Cancer Screening Rates

March 21, 2018 updated by: Noah Ivers, Women's College Hospital

Testing a Behavioural Approach to Improving Cancer Screening Rates Through Increased Use of Primary Care Feedback Reports

Family doctors can play a critical role in successfully arranging cancer screening tests to occur, especially if they know which patients are due for these tests. However, they don't always interact with or take advantage of registry data to this end. For example, in Ontario, the Screening Activity Report provides exactly this information to family doctors, helping them identify their patients who are overdue for screening. Unfortunately, less than half of family doctors regularly use the Screening Activity Report even though they get monthly email reminders. One possible reason is that the reminders they receive are not designed to compel action. They are easy for family doctors to miss or dismiss. This study will compare multiple different ways of designing the reminders. The different versions of the email are tested in a 2^3 factorial trial testing three behaviour change techniques to see which ones will lead to more family physicians interacting with the Screening Activity Report and at increasing the number of patients that get all the appropriate screening tests for cervical, breast, and/or colon cancer.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Screening is an important way to prevent cancer-related death, but many Ontarians do not receive guideline-recommended screening for cervical, breast, and colon cancer. Family physicians can play a critical role in successfully increasing screening rates. A recent evaluation by members of our team suggests that Screening Activity Report (SAR) use is associated with improved cancer screening, but there remains substantial room for improvement. For the SAR to reach its full potential to decrease cancer-related death by improving screening rates, family physicians must regularly access it and take the appropriate actions. Currently, family physicians receive monthly email reminders, which state that new data are available, but do not describe the benefits of the SAR for physicians or their patients. It is easy to imagine how a busy doctor would fail to act upon such emails, resulting in suboptimal use of the SAR and leading to avoidable delays in cancer screening, and management. Indeed, CCO data show that less than half of recipients attend to this email and <7% click through to the SAR. The objectives for this trial are to compare different versions of the reminders in a randomized trial to identify the features that most increase use of the SAR. This is a pragmatic, 2^3 factorial trial, comparing behaviour change techniques incorporated within email reminders to doctors increase their use of the SAR. Participants are those who are already sent monthly emails by CCO regarding the SAR. The trial will randomly assign participants to one of eight modified emails to determine which content is most effective at driving SAR-use over 4 months. With an expected sample size of over 5700 family physicians, we anticipate power to see differences of 3% across experimental conditions.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
5525

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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
    • Ontario
      • Toronto, Ontario, Canada, M5G 2L7
        • Cancer Care Ontario

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Family physicians are eligible if they have signed up for the SAR and already receive reminder emails as part of their registration process for the SAR with CCO.

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: HEALTH_SERVICES_RESEARCH
  • Allocation: RANDOMIZED
  • Interventional Model: FACTORIAL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
NO_INTERVENTION: Email #1: FULLY TURNED OFF
No behavioural change techniques (BCTs) 'turned on' in the email. The email would contain only standardized content.
EXPERIMENTAL: Email #2: ANTICIPATED REGRET
Anticipated regret content + standardized content
Behavioral: Anticipated regret
Induce awareness of future regret about the unwanted behaviour
EXPERIMENTAL: Email #3: MATERIAL INCENTIVE
Material incentive content + standardized content
Behavioral: Material incentive
Inform that valued objects will be delivered if and only if that has been progress in performing the desired behaviours
EXPERIMENTAL: Email #4: PROBLEM SOLVING
Problem solving content + standardized content
Behavioral: Problem solving
Analyze or prompt the person to factors that influence the behaviour and select strategies that help overcome barriers
EXPERIMENTAL: Email #5: REGRET + INCENTIVE
Anticipated regret content + Material incentive content + standardized content
Behavioral: Anticipated regret
Induce awareness of future regret about the unwanted behaviour
Behavioral: Material incentive
Inform that valued objects will be delivered if and only if that has been progress in performing the desired behaviours
EXPERIMENTAL: Email #6: REGRET + PROBLEM SOLVING
Anticipated regret content + Problem solving content + standardized content
Behavioral: Anticipated regret
Induce awareness of future regret about the unwanted behaviour
Behavioral: Problem solving
Analyze or prompt the person to factors that influence the behaviour and select strategies that help overcome barriers
EXPERIMENTAL: Email #7: INCENTIVE + PROBLEM SOLVING
Material incentive content + Problem solving content + standardized content
Behavioral: Material incentive
Inform that valued objects will be delivered if and only if that has been progress in performing the desired behaviours
Behavioral: Problem solving
Analyze or prompt the person to factors that influence the behaviour and select strategies that help overcome barriers
EXPERIMENTAL: Email #8: ALL BCTs
Anticipated regret content + Material incentive content + Problem solving content + standardized content
Behavioral: Anticipated regret
Induce awareness of future regret about the unwanted behaviour
Behavioral: Material incentive
Inform that valued objects will be delivered if and only if that has been progress in performing the desired behaviours
Behavioral: Problem solving
Analyze or prompt the person to factors that influence the behaviour and select strategies that help overcome barriers

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
SAR access
Time Frame: 4 months
The primary outcome will be whether eligible family physicians access the SAR during the 4 months of the trial (Yes/No)
4 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
SAR access rate
Time Frame: 4 months
Number of times the SAR was accessed
4 months
Adherence to screening guidelines for breast, colon, and cervical cancer in patients of eligible PCPs
Time Frame: 4 months
Proportion of patients meeting screening guidelines for breast, colon, and cervical cancer; and efforts made by participants to access the SAR-use
4 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Process Measures: contact made with Cancer Care Ontario
Time Frame: 4 months
Number of calls to CCO contact centre regarding the SAR
4 months

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Women's College Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Ottawa Hospital Research Institute
Cancer Care Ontario
Laval University
Ontario Institute for Cancer Research

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

Helpful Links

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 (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 10, 2017

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2017

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 18, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 18, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 21, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 22, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 21, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2017-004-E

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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