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

NCT05832138 | Not Yet Recruiting

• 1 other identifier: 4152
• Study Type: interventional
• Target: 900
• Locations: 0 countries
• Sites: N/A

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. 1.Study invitation letter and invitation reminder
2. 2.Those who sign up for ONLOOP will receive personalized health information and a screening reminder. Survivors will receive information about:
3. 3.their cancer treatment
4. 4.their risk(s) for late effects
5. 5.the screening tests they should do
6. 6.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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Completion of guideline-recommended surveillance tests

  24 months

• Completion of each type of surveillance test

  12 months, 24 months

• Completion of all guideline-recommended surveillance tests

  12 months, 24 months

• Visits to primary care professionals and cancer specialists

  12 months, 24 months

• Use of other healthcare services

  12 months, 24 months

Study Arms (2)

Intervention

EXPERIMENTAL

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

Behavioral: ONLOOP program

Delayed Intervention

OTHER

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

Interventions

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)

Delayed Intervention; Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• The Hospital for Sick Children: lead
• Women's College Hospital: collaborator
• Ottawa Hospital Research Institute: collaborator

Related Publications (1)

• Shuldiner J, Lam E, Shah N, Grimshaw J, Desveaux L, Heisey R, Taccone MS, Taljaard M, Thavorn K, Hodgson D, Gupta S, Lofters A, Ivers N, Nathan PC. Protocol for the ONLOOP trial: pragmatic randomized trial evaluating a province-wide system of personalized reminders for evidence-based surveillance tests in adult survivors of childhood cancer in Ontario. Implement Sci. 2024 Feb 23;19(1):19. doi: 10.1186/s13012-024-01347-x.

  PMID: 38395903 DERIVED

MeSH Terms

Conditions

Neoplasms; Heart Diseases; Neoplasms, Second Primary; Colorectal Neoplasms; Breast Neoplasms

Condition Hierarchy (Ancestors)

Cardiovascular Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Paul Nathan, MD, MSc

  The Hospital for Sick Children

  PRINCIPAL INVESTIGATOR

• Noah Ivers, MD, PhD

  Women's College Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emily Lam, MSc

CONTACT

416-813-1076; emily.lam@sickkids.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Oncologist

Study Record Dates

• First Submitted: April 14, 2023
• First Posted: April 27, 2023
• Study Start: October 1, 2025
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: October 6, 2025

Record last verified: 2025-09