SurvivorshipNCT05832138
ONLOOP Trial: Evaluating a New Surveillance and Support System for Survivors of Childhood Cancer in Ontario
A study testing ONLOOP program in people with Survivorship and Cancer, run by The Hospital for Sick Children.
Trial summary
The treatments that aim to cure cancer in children can lead to "late effects" such as second cancers and heart disease. Screening tests can help find late effects, but most adult survivors of childhood cancer do not complete these tests. These survivors are at risk for harm that can be prevented. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Survivorship, Cancer, Heart Diseases
- What is being tested?
- ONLOOP program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 900 participants
- Where
- No sites listed yet
- Study dates
- Oct 2025to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Survivors of childhood cancer who are currently aged 18 and older
- Diagnosed with cancer before age 18 between 1986-2017
- At least 5 years from most recent childhood cancer event (latest of primary diagnosis, relapse, or second cancer before age 18)
- Treated at one of Ontario's five specialized childhood cancer programs
- Received radiation and/or anthracycline treatment that increased the survivor's risk of cardiomyopathy, breast cancer, and/or colorectal cancer
- Overdue for guideline-recommended surveillance by ≥6 months (mammogram and breast MRI, colonoscopy, and/or echocardiogram)
Who cannot join
- Was not diagnosed or was not fully treated at one of Ontario's five pediatric cancer centres
- Developed a second cancer or relapse of their primary cancer after age 18
- Not currently living in Ontario or address deemed ineligible by Ontario Health
- Opted out of a similar Ontario Health program (eg, the Ontario Breast Screening Program)
- Previously opted out of receiving invitations for Ontario Health research studies or similar communications
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
The treatments that aim to cure cancer in children can lead to "late effects" such as second cancers and heart disease. Screening tests can help find late effects, but most adult survivors of childhood cancer do not complete these tests. These survivors are at risk for harm that can be prevented.
The investigators have developed a program called ONLOOP to remind survivors in Ontario, Canada to get the screening tests they need. ONLOOP reminds survivors who are at higher risk for heart disease, breast cancer, and/or colorectal cancer to complete their echocardiograms, mammograms and breast MRIs, and/or colonoscopies.
Read more
The goal of this clinical trial is to find out how well ONLOOP helps adult survivors of childhood cancer complete their screening tests. The investigators also want to see if it could be turned into a long-term program in Ontario. Eligible survivors will be randomly assigned to either receive intervention materials or continue with usual care for 13 months before receiving intervention materials.
The intervention includes usual care plus these ONLOOP materials:
- Study invitation letter and invitation reminder
- Those who sign up for ONLOOP will receive personalized health information and a screening reminder. Survivors will receive information about:
- their cancer treatment
- their risk(s) for late effects
- the screening tests they should do
- Participants have the option to provide their family doctor's or nurse practitioner's contact information. For those who consent, the study team will send their family doctor or nurse practitioner a letter with details about their cancer diagnosis and treatment. The letter will also remind them to talk to their patient about their health and screening test(s) needed.
- Conditions
- Survivorship, Cancer, Heart Diseases, Secondary Cancer, Colorectal Cancer, Breast Cancer
- Being tested
- ONLOOP program
- Keywords
- Surveillance, Guideline-recommended surveillance, Implementation science, Reminder system, Intervention
- Medical subject headings
- Neoplasms, Heart Diseases, Neoplasms, Second Primary, Colorectal Neoplasms, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ONLOOP programBehavioural
Participants will receive ONLOOP program intervention materials: a study invitation letter, personalized health information, and a reminder to complete their guideline-recommended surveillance test(s)
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Usual care plus ONLOOP program materials:
1. Study invitation letter and invitation reminder 5 weeks later
2. For those who sign up: receipt of a personalized health toolkit and then a screening reminder 6 months later
3. Optional: Engagement of primary care provider through an introductory letter and then a reminder letter sent 6 months later Receives: Behavioral: ONLOOP program |
| Delayed Intervention | Other | Usual care plus delayed ONLOOP:
Survivors will receive usual care for 13 months after study invitation packages are mailed out to the intervention arm. At that point, survivors in this group will also receive the study invitation package. Receives: Behavioral: ONLOOP program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Completion of guideline-recommended surveillance tests
Proportion of survivors who complete one or more of the guideline-recommended cardiac, breast or colon surveillance tests (echocardiography, mammogram and breast MRI, colonoscopy) during the 12 months after study cohort randomization
Measured: 12 months
Secondary outcomes (5)
Completion of guideline-recommended surveillance tests
Proportion of survivors who complete one or more of the guideline-recommended cardiac, breast or colon surveillance tests (echocardiography, mammogram and breast MRI, colonoscopy) during the 24 months after study cohort randomization
Measured: 24 months
Completion of each type of surveillance test
Proportion of survivors who complete each type of surveillance test (among those eligible for the test)
Measured: 12 months, 24 months
Completion of all guideline-recommended surveillance tests
Proportion of survivors who are fully up-to-date according to surveillance guidelines
Measured: 12 months, 24 months
Visits to primary care professionals and cancer specialists
Number of outpatient visits to primary care professionals and to cancer specialists
Measured: 12 months, 24 months
Use of other healthcare services
Rates of emergency department visits and/or hospitalizations to understand impact on health system resources
Measured: 12 months, 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2023
- Study startOct 2025 (estimated)
- Primary completionNov 2027 (estimated)
- Study completionDec 2028 (estimated)
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 SurvivorshipStudies 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 900 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Collaborators
- Women's College Hospital, Ottawa Hospital Research Institute
- Responsible party
- Principal investigator, Paul Nathan, The Hospital for Sick Children
- Investigators
- Paul Nathan, MD, MSc, Principal investigator, The Hospital for Sick ChildrenNoah Ivers, MD, PhD, Principal investigator, Women's College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05832138
- Sponsor's protocol ID
- 4152
- Status last verified
- Sep 2025
- First submitted
- 14 Apr 2023
- Last updated
- 6 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Shuldiner J, Lam E, Shah N, Grimshaw J, Desveaux L, Heisey R, Taccone MS, Taljaard M, Thavorn K, Hodgson D, Gupta S, Lofters A, Ivers N, Nathan PC. Protocol for the ONLOOP trial: pragmatic randomized trial evaluating a province-wide system of personalized reminders for evidence-based surveillance tests in adult survivors of childhood cancer in Ontario. Implement Sci. 2024 Feb 23;19(1):19. doi: 10.1186/s13012-024-01347-x.
PubMed 38395903
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ONLOOP Trial: Evaluating a New Surveillance and Support System for Survivors of Childhood Cancer in Ontario
- ClinicalTrials.gov ID
- NCT05832138
- Acronym / sponsor ID
- 4152
- Conditions
- Survivorship, Cancer, Heart Diseases, Secondary Cancer, Colorectal Cancer, Breast Cancer
- Keywords
- Surveillance, Guideline-recommended surveillance, Implementation science, Reminder system, Intervention
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 900 participants (estimated)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Collaborators
- Women's College Hospital, Ottawa Hospital Research Institute
- Study start
- Oct 2025 (estimated)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 27 Apr 2023 (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.
The treatments that aim to cure cancer in children can lead to "late effects" such as second cancers and heart disease. Screening tests can help find late effects, but most adult survivors of childhood cancer do not complete these tests. These survivors are at risk for harm that can be prevented.
The investigators have developed a program called ONLOOP to remind survivors in Ontario, Canada to get the screening tests they need. ONLOOP reminds survivors who are at higher risk for heart disease, breast cancer, and/or colorectal cancer to complete their echocardiograms, mammograms and breast MRIs, and/or colonoscopies.
The goal of this clinical trial is to find out how well ONLOOP helps adult survivors of childhood cancer complete their screening tests. The investigators also want to see if it could be turned into a long-term program in Ontario. Eligible survivors will be randomly assigned to either receive intervention materials or continue with usual care for 13 months before receiving intervention materials.
The intervention includes usual care plus these ONLOOP materials:
- Study invitation letter and invitation reminder
- Those who sign up for ONLOOP will receive personalized health information and a screening reminder. Survivors will receive information about:
- their cancer treatment
- their risk(s) for late effects
- the screening tests they should do
- Participants have the option to provide their family doctor's or nurse practitioner's contact information. For those who consent, the study team will send their family doctor or nurse practitioner a letter with details about their cancer diagnosis and treatment. The letter will also remind them to talk to their patient about their health and screening test(s) needed.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: ONLOOP programUsual care plus ONLOOP program materials: 1. Study invitation letter and invitation reminder 5 weeks later 2. For those who sign up: receipt of a personalized health toolkit and then a screening reminder 6 months later 3. Optional: Engagement of primary care provider through an introductory letter and then a reminder letter sent 6 months later |
| Delayed Intervention | Other | Behavioral: ONLOOP programUsual care plus delayed ONLOOP: Survivors will receive usual care for 13 months after study invitation packages are mailed out to the intervention arm. At that point, survivors in this group will also receive the study invitation package. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Survivors of childhood cancer who are currently aged 18 and older
- Diagnosed with cancer before age 18 between 1986-2017
- At least 5 years from most recent childhood cancer event (latest of primary diagnosis, relapse, or second cancer before age 18)
- Treated at one of Ontario's five specialized childhood cancer programs
- Received radiation and/or anthracycline treatment that increased the survivor's risk of cardiomyopathy, breast cancer, and/or colorectal cancer
Key exclusion criteria (5 listed)
- Was not diagnosed or was not fully treated at one of Ontario's five pediatric cancer centres
- Developed a second cancer or relapse of their primary cancer after age 18
- Not currently living in Ontario or address deemed ineligible by Ontario Health
- Opted out of a similar Ontario Health program (eg, the Ontario Breast Screening Program)
- Previously opted out of receiving invitations for Ontario Health research studies or similar communications
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 |
|---|---|---|
| ONLOOP programParticipants will receive ONLOOP program intervention materials: a study invitation letter, personalized health information, and a reminder to complete their guideline-recommended surveillance test(s) | Behavioural | Delayed Intervention, Intervention |
Primary outcome
Completion of guideline-recommended surveillance tests
Time frame: 12 months
Proportion of survivors who complete one or more of the guideline-recommended cardiac, breast or colon surveillance tests (echocardiography, mammogram and breast MRI, colonoscopy) during the 12 months after study cohort randomization
5 secondary outcomes
Completion of guideline-recommended surveillance tests
Time frame: 24 months
Completion of each type of surveillance test
Time frame: 12 months, 24 months
Completion of all guideline-recommended surveillance tests
Time frame: 12 months, 24 months
Visits to primary care professionals and cancer specialists
Time frame: 12 months, 24 months
Use of other healthcare services
Time frame: 12 months, 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2025.
- Derived from this study: PubMed 38395903Shuldiner J, Lam E, Shah N, Grimshaw J, Desveaux L, Heisey R, Taccone MS, Taljaard M, Thavorn K, Hodgson D, Gupta S, Lofters A, Ivers N, Nathan PC. Protocol for the ONLOOP trial: pragmatic randomized trial evaluating a province-wide system of personalized reminders for evidence-based surveillance tests in adult survivors of childhood cancer in Ontario. Implement Sci. 2024 Feb 23;19(1):19. doi: 10.1186/s13012-024-01347-x.
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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.
Paul Nathan, MD, MSc principal investigator
The Hospital for Sick Children
Noah Ivers, MD, PhD principal investigator
Women's College Hospital
Questions about this trial
What is this clinical trial studying?
A study testing ONLOOP program in people with Survivorship and Cancer, run by The Hospital for Sick Children.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emily Lam, MSc (416-813-1076, emily.lam@sickkids.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Completion of guideline-recommended surveillance tests (time frame: 12 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 NCT05832138, 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 6 Oct 2025.