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Trial Title:
ONLOOP Trial: Evaluating a New Surveillance and Support System for Survivors of Childhood Cancer in Ontario
NCT ID:
NCT05832138
Condition:
Survivorship
Cancer
Heart Diseases
Secondary Cancer
Colorectal Cancer
Breast Cancer
Conditions: Official terms:
Heart Diseases
Conditions: Keywords:
Surveillance
Guideline-recommended surveillance
Implementation science
Reminder system
Intervention
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Screening
Masking:
Single (Participant)
Intervention:
Intervention type:
Behavioral
Intervention name:
ONLOOP program
Description:
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)
Arm group label:
Delayed Intervention
Arm group label:
Intervention
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.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
September 2024
Completion date:
October 2026
Lead sponsor:
Agency:
The Hospital for Sick Children
Agency class:
Other
Collaborator:
Agency:
Women's College Hospital
Agency class:
Other
Collaborator:
Agency:
Ottawa Hospital Research Institute
Agency class:
Other
Source:
The Hospital for Sick Children
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05832138
