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.

Study Overview

• Status: Not yet recruiting
• Conditions: Heart Diseases; Cancer; Breast Cancer; Colorectal Cancer; Survivorship; Secondary Cancer
• Intervention / Treatment: Behavioral: ONLOOP program

• Study Type: Interventional
• Enrollment (Estimated): 900
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Emily Lam, MSc; Phone Number: 416-813-1076; Email: emily.lam@sickkids.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; Usual care plus ONLOOP program materials: Study invitation letter and invitation reminder 5 weeks later; For those who sign up: receipt of a personalized health toolkit and then a screening reminder 6 months later; Optional: Engagement of primary care provider through an introductory letter and then a reminder letter sent 6 months later	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)
Other: Delayed Intervention; 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.	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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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)	12 months, 24 months
Completion of all guideline-recommended surveillance tests	Proportion of survivors who are fully up-to-date according to surveillance guidelines	12 months, 24 months
Visits to primary care professionals and cancer specialists	Number of outpatient visits to primary care professionals and to cancer specialists	12 months, 24 months
Use of other healthcare services	Rates of emergency department visits and/or hospitalizations to understand impact on health system resources	12 months, 24 months

Collaborators and Investigators

• Sponsor: The Hospital for Sick Children
• Collaborators: Ottawa Hospital Research Institute; Women's College Hospital
• Investigators: Principal Investigator: Paul Nathan, MD, MSc, The Hospital for Sick Children; Principal Investigator: Noah Ivers, MD, PhD, Women's College Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2024
• Primary Completion (Estimated): May 1, 2025
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: April 14, 2023
• First Submitted That Met QC Criteria: April 14, 2023
• First Posted (Actual): April 27, 2023

Study Record Updates

• Last Update Posted (Actual): April 23, 2024
• Last Update Submitted That Met QC Criteria: April 22, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Intervention; Surveillance; Implementation science; Guideline-recommended surveillance; Reminder system
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases
• Other Study ID Numbers: 4152

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No