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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05832138
• Other study ID #: 4152
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 2024
• Est. completion date: June 2026

Study information

• Verified date: April 2024
• Source: The Hospital for Sick Children
• Contact: Emily Lam, MSc
• Phone: 416-813-1076
• Email: emily.lam[@]sickkids.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 900
• Est. completion date: June 2026
• Est. primary completion date: May 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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)

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
The Hospital for Sick Children	Ottawa Hospital Research Institute, Women's College Hospital

Outcome

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