Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT05832138

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

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ONLOOP program

Behavioral

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)

Primary outcomes

  1. 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

Secondary outcomes

  1. Completion of guideline-recommended surveillance tests

    Time frame: 24 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 24 months after study cohort randomization

  2. Completion of each type of surveillance test

    Time frame: 12 months, 24 months

    Proportion of survivors who complete each type of surveillance test (among those eligible for the test)

  3. Completion of all guideline-recommended surveillance tests

    Time frame: 12 months, 24 months

    Proportion of survivors who are fully up-to-date according to surveillance guidelines

  4. Visits to primary care professionals and cancer specialists

    Time frame: 12 months, 24 months

    Number of outpatient visits to primary care professionals and to cancer specialists

  5. Use of other healthcare services

    Time frame: 12 months, 24 months

    Rates of emergency department visits and/or hospitalizations to understand impact on health system resources

Study contacts

Contact information is provided by the study sponsor or research team.

Emily Lam, MSc

CONTACT

[email protected]

416-813-1076

Sponsors and collaborators

Lead sponsor

The Hospital for Sick Children

Other

Collaborators

  • Ottawa Hospital Research Institute
  • Women's College Hospital

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Apr 27, 2023
Registry last updated
Oct 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.