Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Women's College Hospital | OTHER |
| Ottawa Hospital Research Institute | OTHER |
Not provided
Not provided
Not provided
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:
Study invitation letter and invitation reminder
Those who sign up for ONLOOP will receive personalized health information and a screening reminder. Survivors will receive information about:
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Usual care plus ONLOOP program materials:
|
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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) |
| 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 |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Emily Lam, MSc | Contact | 416-813-1076 | emily.lam@sickkids.ca |
| Name | Affiliation | Role |
|---|---|---|
| Paul Nathan, MD, MSc | The Hospital for Sick Children | Principal Investigator |
| Noah Ivers, MD, PhD | Women's College Hospital | Principal Investigator |
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38395903 | Derived | 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. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D006331 | Heart Diseases |
| D016609 | Neoplasms, Second Primary |
| D015179 | Colorectal Neoplasms |
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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 |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |