ONLOOP Trial: Evaluating a New Surveillance and Support System for Survivors of Childhood Cancer in Ontario
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 900
- 主要终点
- Completion of guideline-recommended surveillance tests
研究概览
简要总结
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:
-
their cancer treatment
-
their risk(s) for late effects
-
the screening tests they should do
-
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
结局指标
主要结局
Completion of guideline-recommended surveillance tests
时间窗: 12 months
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
次要结局
- Completion of guideline-recommended surveillance tests(24 months)
- Visits to primary care professionals and cancer specialists(12 months, 24 months)
- Completion of all guideline-recommended surveillance tests(12 months, 24 months)
- Completion of each type of surveillance test(12 months, 24 months)
- Use of other healthcare services(12 months, 24 months)
研究者
Paul Nathan
Staff Oncologist
The Hospital for Sick Children