Early Detection of CancerNCT03124316
Testing a Behavioural Approach to Improving Cancer Screening Rates
A study testing Anticipated regret, Material incentive and Problem solving in people with Early Detection of Cancer and Clinical Trial, run by Women's College Hospital at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Early Detection of Cancer, Clinical Trial
- What is being tested?
- Anticipated regret, Material incentive and Problem solving
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,525 participants
- Where
- 1 siteCanada
- Study dates
- 10 May 2017to 30 Sep 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Early Detection of Cancer, Clinical Trial
- Being tested
- Anticipated regret, Material incentive, Problem solving
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anticipated regretBehavioural
Induce awareness of future regret about the unwanted behaviour
Material incentiveBehavioural
Inform that valued objects will be delivered if and only if that has been progress in performing the desired behaviours
Problem solvingBehavioural
Analyze or prompt the person to factors that influence the behaviour and select strategies that help overcome barriers
| Study group | Role | What they receive |
|---|---|---|
| Email #1: FULLY TURNED OFF | No intervention | No behavioural change techniques (BCTs) 'turned on' in the email. The email would contain only standardized content. |
| Email #2: ANTICIPATED REGRET | Experimental | Anticipated regret content + standardized content Receives: Behavioral: Anticipated regret |
| Email #3: MATERIAL INCENTIVE | Experimental | Material incentive content + standardized content Receives: Behavioral: Material incentive |
| Email #4: PROBLEM SOLVING | Experimental | Problem solving content + standardized content Receives: Behavioral: Problem solving |
| Email #5: REGRET + INCENTIVE | Experimental | Anticipated regret content + Material incentive content + standardized content Receives: Behavioral: Anticipated regret; Behavioral: Material incentive |
| Email #6: REGRET + PROBLEM SOLVING | Experimental | Anticipated regret content + Problem solving content + standardized content Receives: Behavioral: Anticipated regret; Behavioral: Problem solving |
| Email #7: INCENTIVE + PROBLEM SOLVING | Experimental | Material incentive content + Problem solving content + standardized content Receives: Behavioral: Material incentive; Behavioral: Problem solving |
| Email #8: ALL BCTs | Experimental | Anticipated regret content + Material incentive content + Problem solving content + standardized content Receives: Behavioral: Anticipated regret; Behavioral: Material incentive; Behavioral: Problem solving |
What is being measured
The primary outcome is the main question the study is designed to answer.
SAR access
The primary outcome will be whether eligible family physicians access the SAR during the 4 months of the trial (Yes/No)
Measured: 4 months
Secondary outcomes (2)
SAR access rate
Number of times the SAR was accessed
Measured: 4 months
Adherence to screening guidelines for breast, colon, and cervical cancer in patients of eligible PCPs
Proportion of patients meeting screening guidelines for breast, colon, and cervical cancer; and efforts made by participants to access the SAR-use
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2017
- Study start10 May 2017
- Primary completion30 Sep 2017
- Study completion30 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Early Detection of CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- We will test three components of reminders to family physicians that could be embedded independently, in combinations of two, and all together in a reminder email. Family physicians will be randomly allocated to one of 8 experimental conditions. Each experimental condition comprises a different combination of the behaviour change techniques featured in the redesigned email reminder.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 5,525 participants (actual)
Sponsor and investigators
- Lead sponsor
- Women's College Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ontario Institute for Cancer Research, Cancer Care Ontario, Ottawa Hospital Research Institute, Laval University
- Responsible party
- Principal investigator, Noah Ivers, Women's College Hospital
- Investigators
- Noah Ivers, MD, PhD, Principal investigator, Women's College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03124316
- Sponsor's protocol ID
- 2017-004-E
- Status last verified
- Mar 2018
- First submitted
- 18 Apr 2017
- Last updated
- 22 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Vaisson G, Witteman HO, Bouck Z, Bravo CA, Desveaux L, Llovet D, Presseau J, Saragosa M, Taljaard M, Umar S, Grimshaw JM, Tinmouth J, Ivers NM. Testing Behavior Change Techniques to Encourage Primary Care Physicians to Access Cancer Screening Audit and Feedback Reports: Protocol for a Factorial Randomized Experiment of Email Content. JMIR Res Protoc. 2018 Feb 16;7(2):e11. doi: 10.2196/resprot.9090.
PubMed 29453190
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing a Behavioural Approach to Improving Cancer Screening Rates Through Increased Use of Primary Care Feedback Reports
- ClinicalTrials.gov ID
- NCT03124316
- Acronym / sponsor ID
- 2017-004-E
- Conditions
- Early Detection of Cancer, Clinical Trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5,525 participants (actual)
- Lead sponsor
- Women's College HospitalUniversity, hospital or other
- Collaborators
- Ontario Institute for Cancer Research, Cancer Care Ontario, Ottawa Hospital Research Institute, Laval University
- Study start
- 10 May 2017 (actual)
- Primary completion
- 30 Sep 2017 (actual)
- Study completion
- 30 Sep 2017 (actual)
- First posted
- 21 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 8
- Model description
- We will test three components of reminders to family physicians that could be embedded independently, in combinations of two, and all together in a reminder email. Family physicians will be randomly allocated to one of 8 experimental conditions. Each experimental condition comprises a different combination of the behaviour change techniques featured in the redesigned email reminder.
| Arm | Type | Receives |
|---|---|---|
| Email #1: FULLY TURNED OFF | No intervention | –No behavioural change techniques (BCTs) 'turned on' in the email. The email would contain only standardized content. |
| Email #2: ANTICIPATED REGRET | Experimental | Behavioral: Anticipated regretAnticipated regret content + standardized content |
| Email #3: MATERIAL INCENTIVE | Experimental | Behavioral: Material incentiveMaterial incentive content + standardized content |
| Email #4: PROBLEM SOLVING | Experimental | Behavioral: Problem solvingProblem solving content + standardized content |
| Email #5: REGRET + INCENTIVE | Experimental | Behavioral: Anticipated regret, Behavioral: Material incentiveAnticipated regret content + Material incentive content + standardized content |
| Email #6: REGRET + PROBLEM SOLVING | Experimental | Behavioral: Anticipated regret, Behavioral: Problem solvingAnticipated regret content + Problem solving content + standardized content |
| Email #7: INCENTIVE + PROBLEM SOLVING | Experimental | Behavioral: Material incentive, Behavioral: Problem solvingMaterial incentive content + Problem solving content + standardized content |
| Email #8: ALL BCTs | Experimental | Behavioral: Anticipated regret, Behavioral: Material incentive, Behavioral: Problem solvingAnticipated regret content + Material incentive content + Problem solving content + standardized content |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anticipated regretInduce awareness of future regret about the unwanted behaviour | Behavioural | Email #2: ANTICIPATED REGRET, Email #5: REGRET + INCENTIVE, Email #6: REGRET + PROBLEM SOLVING, Email #8: ALL BCTs |
| Material incentiveInform that valued objects will be delivered if and only if that has been progress in performing the desired behaviours | Behavioural | Email #3: MATERIAL INCENTIVE, Email #5: REGRET + INCENTIVE, Email #7: INCENTIVE + PROBLEM SOLVING, Email #8: ALL BCTs |
| Problem solvingAnalyze or prompt the person to factors that influence the behaviour and select strategies that help overcome barriers | Behavioural | Email #4: PROBLEM SOLVING, Email #6: REGRET + PROBLEM SOLVING, Email #7: INCENTIVE + PROBLEM SOLVING, Email #8: ALL BCTs |
Primary outcome
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)
2 secondary outcomes
SAR access rate
Time frame: 4 months
Adherence to screening guidelines for breast, colon, and cervical cancer in patients of eligible PCPs
Time frame: 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2018.
- Derived from this study: PubMed 29453190Vaisson G, Witteman HO, Bouck Z, Bravo CA, Desveaux L, Llovet D, Presseau J, Saragosa M, Taljaard M, Umar S, Grimshaw JM, Tinmouth J, Ivers NM. Testing Behavior Change Techniques to Encourage Primary Care Physicians to Access Cancer Screening Audit and Feedback Reports: Protocol for a Factorial Randomized Experiment of Email Content. JMIR Res Protoc. 2018 Feb 16;7(2):e11. doi: 10.2196/resprot.9090.
- CCO SAR websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Noah Ivers, MD, PhD principal investigator
Women's College Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anticipated regret, Material incentive and Problem solving in people with Early Detection of Cancer and Clinical Trial, run by Women's College Hospital at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SAR access (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03124316, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2018.