NCT07030686招募中不适用
Association Between Exercise, Patient-Reported Outcomes, and Clinical Events in Adult Cancer Survivors
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 61,100
- 试验地点
- 3
- 主要终点
- Distant disease-free survival (DDFS)
研究概览
简要总结
This protocol is a retrospective study using observational data to conduct a target trial emulation to examine the association of exercise on cancer specific endpoints and other clinical outcomes in cancer survivors.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Target trial (ideal RCT)
- •Adult (≥18 years of age) patients with history of primary invasive cancer under surveillance at Memorial Sloan Kettering Cancer Center (MSK).
- •Completion of an exercise survey (baseline) as part of MSK Cancer Survivorship Program and completion of a historical survey in the MSK Cancer Survivorship Program 9-15 months (time th) prior reporting non-exercising status [i.e., reporting <10 metabolic equivalent-hours per week (MET-h/week)]. Patients completing an additional exercise survey between th and baseline are excluded.
- •No evidence of recurrent or metastatic disease in the 15 months prior to the baseline exercise assessment
- •Completion of all definitive primary adjuvant therapy (e.g., chemotherapy, radiotherapy, targeted therapy) at least 3 months prior to completion of the historical exercise survey in a MSK Cancer Survivorship Program. Adjuvant hormonal therapy is permitted at any time.
- •Undergoing surveillance in the Cancer Survivorship Program at MSK
- •Emulation using observational data
- •Adult (≥18 years of age) cancer survivors under surveillance at Memorial Sloan Kettering Cancer Center (MSK) between 2011 and
- •Assessment of self-reported exercise status via completion of an exercise survey as part of MSK Cancer Survivorship Program standard intake (baseline assessment).
- •Non-exercising (i.e., reporting <5 MET-h/week) via completion of an exercise survey as part of MSK Cancer Survivorship Program standard intake 9-15 months prior to the baseline exercise assessment (historical exercise survey).
- •Documented history of the following absolute contraindications to moderate-intensity exercise at any time prior to the baseline exercise assessment, assessed using the Elixhauser ICD codes: Congestive heart failure, valvular disease, chronic pulmonary disease, or renal failure.
- •No evidence of recurrent or metastatic disease via radiological or pathological in EMR in the 15 months prior to the baseline exercise assessment.
- •Completion of all definitive primary adjuvant therapy (e.g., chemotherapy, radiotherapy, targeted therapy) at least 3 months prior to completion of historical exercise survey (i.e., at least 3 months prior to t-1) as part of MSK Cancer Survivorship Program standard intake. Adjuvant endocrine therapy is permitted.
排除标准
- 未提供
研究组 & 干预措施
Arm 1: Usual Care
Arm 2: Exercise
干预措施: Exercise (Behavioral)
结局指标
主要结局
Distant disease-free survival (DDFS)
时间窗: 5 years
To estimate the association of exercise vs. usual care (control) with Distant disease-free survival (DDFS) among patients following the completion of active treatment for the primary index cancer being monitored at MSK.
次要结局
未报告次要终点
研究者
研究点 (3)
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