Heart and Blood Diseases

All Conditions

Neoplasms

Skin and Connective Tissue Diseases

Symptoms and General Pathology

Heart Diseases

Breast Neoplasms

Neoplasm Metastasis

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

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.

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)

ONLOOP program

Emily Lam, MSc

Paul Nathan, MD, MSc

Noah Ivers, MD, PhD

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.

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

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

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

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

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

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

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

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
ONLOOP Trial: Evaluating a New Surveillance and Support System for Survivors of Childhood Cancer in Ontario	NCT05832138	Survivorship Cancer Heart Diseases Secondary Cance... Colorectal Canc... Breast Cancer	ONLOOP program	18 Years -	The Hospital for Sick Children
ONLOOP Trial: Evaluating a New Surveillance and Support System for Survivors of Childhood Cancer in Ontario	NCT05832138	Survivorship Cancer Heart Diseases Secondary Cance... Colorectal Canc... Breast Cancer	ONLOOP program	18 Years -	The Hospital for Sick Children
ONLOOP Trial: Evaluating a New Surveillance and Support System for Survivors of Childhood Cancer in Ontario	NCT05832138	Survivorship Cancer Heart Diseases Secondary Cance... Colorectal Canc... Breast Cancer	ONLOOP program	18 Years -	The Hospital for Sick Children

Spots Global Cancer Trial Database for reminder system