Multimodal PReoperative Exercise to Decrease PostoperAtive Disability, Cancer RecurrencE and Mortality in Older People With Frailty
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 413
- 试验地点
- 1
- 主要终点
- Event free survival (EFS) in the 5 years after surgery
研究概览
简要总结
Our team recently closed recruitment for the PREPARE Trial: PReoperative Exercise to decrease PostoperAtive complication Rates and disability scorEs. The trial enrolled a total of 850 participants; 523 of which were recruited locally at The Ottawa Hospital (TOH). Of the 523 enrolled at TOH, 413 patient participants were on the pathway for cancer surgery and have either completed the study or are in follow-up (participants who withdrew from the full study have been excluded from the sample size in this sub-study proposal). Unexpectedly, almost 80% of the PREPARE Trial sample was linked to cancer surgery - most likely because cancer surgeries were prioritized during the pandemic. This provides us with the opportunity, and perhaps the responsibility, to specifically assess oncology related outcomes. We propose to follow this TOH sub-group of oncology patients for five years following their surgical date, by retrospectively collecting clinical and health administrative data at annual timepoints.
详细描述
Background: Among cancer surgery patients, systematic reviews suggest a 55% relative improvement in cancer free survival after multimodal prehabilitation. Unfortunately, prehabilitation trials have largely excluded individuals living with frailty. Simply put, we urgently require data from multicenter prehabilitation trials testing interventions that: A) support adequate adherence; and B) focus on older people with frailty having cancer surgery.
Research aims:
- Does participation in home-based, multimodal prehabilitation improve 5-year event free survival among older adults with frailty having cancer surgery?
- Does participation in home-based, multimodal prehabilitation improve physical recovery as assessed using patient reported disability scores across the first year after surgery among older adults with frailty having cancer surgery?
- Does participation in home-based, multimodal prehabilitation lead to earlier return to intended oncologic treatment among older adults with frailty having cancer surgery?
Methods:
Design, setting and participants: This is a cancer-specific sub-study of the PREPARE Trial. This will be a retrospective cohort study performed using clinical and health administrative data from the electronic medical record (EPIC). People => 60 years old with frailty (Clinical Frailty Scale score of 4/9) and cancer having major elective non-cardiac surgery (vascular, intrathoracic, intraabdominal, pelvic, ENT) with expected length of stay of => 2 days will be included.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged ≥60 years
- •Scheduled, or on the pathway, for elective surgery eLOS ≥2 days
- •Expected surgery date between 3 and 12 weeks from enrollment
- •Clinical Frailty Scale (CFS) score ≥4/9
排除标准
- •Inability to speak English or French
- •Co-morbidity preventing assessment or understanding of questionnaires
- •Unable to be contacted by telephone
- •Unwilling to participate in exercise program
- •Cardiac, neurological or orthopedic procedure
- •Palliative surgery
- •Certain cardiovascular conditions
结局指标
主要结局
Event free survival (EFS) in the 5 years after surgery
时间窗: 5 years
Event free survival (similar to disease free survival, but more appropriate for scenarios where surgery is planned after randomization, but could be precluded by disease progression) will be defined using US Food and Drug Administration (FDA) criteria as: the time after randomization to the earliest of a) progression of disease that precludes surgery, local or distant recurrence, or death due to any cause.
次要结局
- Patient-reported disability trajectory in the year after surgery measured using the World Health Organization Disability Assessment Schedule 2.0 (WHODAS)(1 year after surgery)
- Return to intended oncologic treatment (RIOT)(at 4 months after surgery)