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ONLOOP Trial: Evaluating a New Surveillance and Support System for Survivors of Childhood Cancer in Ontario

ONLOOP Trial: Evaluating a New Surveillance and Support System for Survivors of Childhood Cancer in Ontario

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05832138
Enrollment
900
Registered
2023-04-27
Start date
2025-10-31
Completion date
2028-12-31
Last updated
2025-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer, Cancer, Colorectal Cancer, Heart Diseases, Secondary Cancer, Survivorship

Keywords

Surveillance, Guideline-recommended surveillance, Implementation science, Reminder system, Intervention

Brief 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. 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: 1. Study invitation letter and invitation reminder 2. Those who sign up for ONLOOP will receive personalized health information and a screening reminder. Survivors will receive information about: 1. their cancer treatment 2. their risk(s) for late effects 3. the screening tests they should do 3. 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.

Interventions

BEHAVIORALONLOOP program

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)

Sponsors

Women's College Hospital
CollaboratorOTHER
Ottawa Hospital Research Institute
CollaboratorOTHER
The Hospital for Sick Children
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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)

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Completion of guideline-recommended surveillance tests12 monthsProportion 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

Secondary

MeasureTime frameDescription
Completion of guideline-recommended surveillance tests24 monthsProportion 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
Completion of each type of surveillance test12 months, 24 monthsProportion of survivors who complete each type of surveillance test (among those eligible for the test)
Completion of all guideline-recommended surveillance tests12 months, 24 monthsProportion of survivors who are fully up-to-date according to surveillance guidelines
Visits to primary care professionals and cancer specialists12 months, 24 monthsNumber of outpatient visits to primary care professionals and to cancer specialists
Use of other healthcare services12 months, 24 monthsRates of emergency department visits and/or hospitalizations to understand impact on health system resources

Contacts

Primary ContactEmily Lam, MSc
emily.lam@sickkids.ca416-813-1076

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026