NCT03331406已完成不适用
A Pilot Study of Physical Activity in Older Adults With Metastatic Gastrointestinal Cancer
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Rate of Accrual
研究概览
简要总结
This research study is evaluating the ability for people with metastatic gastrointestinal cancer to participate in a physical activity program.
详细描述
The physical activity program is 12-weeks in length, and includes moderate-intensity aerobic, strength, flexibility, and balance training.
- The goal of the aerobic training is to complete 150 minutes per week of brisk walking.
- The goals of the strength, flexibility, and balance training are to engage in these activities twice per week.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
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
- •Start of trial:
- •A three-month of strict inclusion criteria (Phase 1).
- •At the end of three-months, if at least six participants have not been accrued, inclusion criteria will be expanded for a second three-month recruitment phase (Phase 2).
- •At the end of six-months, an average of two patients per month has not been accrued, a further expand inclusion criteria (Phase 3).
- •Phase 1 (most strict) Eligibility criteria include:
- •Voluntary, signed informed consent;
- •Diagnosis of histologically-confirmed esophageal, gastric, pancreatic, or colorectal that is metastatic or locally-advanced (unresectable);
- •First-line cytotoxic chemotherapy started within four-weeks of enrollment (patients can have reviewed prior adjuvant therapy if completed ≥6 months prior to start of first line chemotherapy for metastatic disease);
- •Age greater than 65 years;
- •Baseline weight-bearing physical activity less than 150 min∙wk-1 using the Paffenbarger physical activity questionnaire;
- •Eastern Cooperative Group Performance Status of 0, 1, or 2;
- •Self-reported ability to walk 400-meters (approximately one city block) without sitting, leaning, or the help of another person or walker;
- •Written physician approval;
- •Life expectancy >3 months;
- •English speaking.
- •Phase 2 (less restrictive) Eligibility criteria will loosen:
- •- The minimum age from greater than 65, to greater than 55;
- •Phase 3 (least restrictive) Eligibility criteria will add:
- •- The minimum age from greater than 55, to greater than
- •Exclusion Criteria
- •Known or suspected brain or other central nervous system metastases;
- •Uncontrolled cardiac or pulmonary disease;
- •Pregnant or breast feeding;
- •Any other condition that may impede testing of the study hypothesis, make it unsafe to engage in the physical activity program, or make the participant not available for end of study assessments (determined by the investigative team).
排除标准
- 未提供
结局指标
主要结局
Rate of Accrual
时间窗: 12 months
Recruit 20 patients within 12 months
Number of participants that adhered to physical activity program
时间窗: 12 Weeks
Demonstrate that at least 50% of patients adhered to at least 50% of the prescribed physical activity program.
次要结局
- Rate of Retention(12 Weeks)
- Number of participants with adverse events(12 Weeks)
- Number of participants that complete assessment procedures(12 Weeks)
研究者
Jeffrey A. Meyerhardt, MD
Prinicipal Investigator
Dana-Farber Cancer Institute
研究点 (2)
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