Heart and Blood Diseases

All Conditions

Neoplasms

Skin and Connective Tissue Diseases

Symptoms and General Pathology

Heart Diseases

Breast Neoplasms

Neoplasm Metastasis

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

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.

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)

ONLOOP program

Emily Lam, MSc

Paul Nathan, MD, MSc

Noah Ivers, MD, PhD

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.

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

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

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

Proportion of survivors who complete each type of surveillance test (among those eligible for the test)

Proportion of survivors who are fully up-to-date according to surveillance guidelines

Number of outpatient visits to primary care professionals and to cancer specialists

Rates of emergency department visits and/or hospitalizations to understand impact on health system resources

Women's College Hospital

Ottawa Hospital Research Institute

The Hospital for Sick Children

Staff Oncologist

Blood and Lymph Conditions

Rare Diseases

Myeloproliferative Disorders

Polycythemia Vera

Polycythemia

Primary Myelofibrosis

Thrombocytosis

Thrombocythemia, Essential

Neoplastic Processes

Bone Marrow Diseases

Hematologic Diseases

Bone Marrow Neoplasms

Hematologic Neoplasms

Blood Platelet Disorders

Hemostatic Disorders

Blood Coagulation Disorders

Hemorrhagic Disorders

Chronic Myeloproliferative Disorders

Essential Thrombocythemia

Amino Acids

All Drugs and Chemicals

Valine

Patients with diagnosis of Myeloproliferative Neoplasms (MPN) including Polycythemia Vera, Essential thrombocytopenia or Myelofibrosis, exposed or not exposed to JAK2V617F mutation, who experienced secondary cancer(s) diagnosed at presentation of MPN or during the course of the myeloproliferative disease.

Patients with diagnosis of Myeloproliferative Neoplasms (MPN) including Polycythemia Vera, Essential thrombocytopenia or Myelofibrosis, exposed or not exposed to JAK2V617F mutation, without history of secondary cancer.

JAK2 V617F is attached to the cytosolic juxtamembrane region of dimeric cytokine receptors, such as EpoR or MPL (TpoR); The JAK2V617F mutation results from a guanine to thymine change at nucleotide 1849 of the cDNA, in exon 14 of the gene. This valine is located at one of the predicted interfaces between JH1 and JH2 domains,

JAK2V617F mutation

Tiziano Barbui, Prof

Guido Finazzi, Dr

The incidence of secondary cancer (SC) in patients with myeloproliferative neoplasms (MPN) is high and comparable to that of thrombosis. However, the identification of patient subgroups that might be at increased susceptibility of developing SC has not been systematically addressed. This international case-control study (MPN-K) is aimed to elucidate the prognostic role of JAK2V617F mutation in predicting the occurrence of SC in patients with classical MPN, polycythemia vera (PV), essential thrombocythemia (ET) and myelofibrosis (MF)

For each recruited case with concomitant diagnosis of myeloproliferative neoplasms (MPN) and secondary cancer each participating center will provide up 3 control patients (1 control for each case could be accepted but the optimal number is 3). Controls are patients with myeloproliferative neoplasms and no history of cancer. Each control will be matched to the paired case for sex, age (+/- 3 years), date of MPN diagnosis (+/- 5 years), and MPN disease duration (+/- 3 years).

Each control is censored at the date of the secondary cancer occurrence in his matched case (index date).

Data will be collected retrospectively from pre-existing medical records and reported by each center on a web-based and validated eCRF developed to record y all study data. In order to maintain patient privacy, all data records will be treated anonymously and no personal data to identify patient will be recorded: patients will be identified in the study by an alphanumeric code.

Secondary Cancers in Myeloproliferative Neoplasms (MPN-K Study)

The ratio of number of patients showing JAK2V617F mutation on the number of patients not exposed to this mutation will be calculated in the group of subjects experiencing second cancer after diagnosis of PV, ET and MF (defined as 'cases') and related (odds ratio) with the ratio of patients exposed on those not exposed to JAK2V617F mutation in the group of subjects with no experience of secondary cancers after diagnosis of PV, ET and MF (this group is defined as 'Control' group)

Characteristics at diagnosis of patients with PV, ET and MF (including other mutations) with occurrence of second cancers (SC) are decribed and compared with those not experiencing SC after diagnosis of myloproliferative neoplasm; the ratio of number of patients exposed to potential risk factors on the number of subjects not exposed will be calculated in the group cases (as defined for primary outcome measure) and related (odds ratio) with the ratio of patient exposed versus not exposed calculated in the subgroup of control.

Group of patients exposed and not exposed to different class of treatments for PV, ET and MF are compared and related in the group of cases and control

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
ONLOOP Trial: Evaluating a New Surveillance and Support System for Survivors of Childhood Cancer in Ontario	NCT05832138	Survivorship Cancer Heart Diseases Secondary Cance... Colorectal Canc... Breast Cancer	ONLOOP program	18 Years -	The Hospital for Sick Children
Secondary Cancers in Myeloproliferative Neoplasms (MPN-K Study)	NCT03745378	Polycythemia Ve... Essential Throm... Myelofibrosis	JAK2V617F mutat...	-	FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS
ONLOOP Trial: Evaluating a New Surveillance and Support System for Survivors of Childhood Cancer in Ontario	NCT05832138	Survivorship Cancer Heart Diseases Secondary Cance... Colorectal Canc... Breast Cancer	ONLOOP program	18 Years -	The Hospital for Sick Children
ONLOOP Trial: Evaluating a New Surveillance and Support System for Survivors of Childhood Cancer in Ontario	NCT05832138	Survivorship Cancer Heart Diseases Secondary Cance... Colorectal Canc... Breast Cancer	ONLOOP program	18 Years -	The Hospital for Sick Children

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