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

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.

Conditions

• Survivorship
• Cancer
• Heart Diseases
• Secondary Cancer
• Colorectal Cancer
• Breast Cancer

Interventions

BEHAVIORAL

ONLOOP 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 & Collaborators

• Women's College Hospital

  collaborator OTHER

• Ottawa Hospital Research Institute

  collaborator OTHER

• The Hospital for Sick Children

  lead OTHER

Principal Investigators

• Paul Nathan, MD, MSc · The Hospital for Sick Children

• Noah Ivers, MD, PhD · Women's College Hospital

Study Design

Allocation

RANDOMIZED

Purpose

SCREENING

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-10-31

Primary Completion

2027-11-30

Completion

2028-12-31