Precise Exercise Regimen for Cancer Care (PERCC): A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Attendance of Exercise Sessions (Feasibility)
研究概览
简要总结
The purpose of this study is to test the feasibility of the Precise Exercise Regimen for Cancer Care (PERCC) exercise program in participants with stage II-III primary lung cancer.
详细描述
This research study is a feasibility pilot study and to test the feasibility of the Precise Exercise Regimen for Cancer Care (PERCC) exercise program in participants with stage II-III primary lung cancer.
The research study procedures include screening for eligibility including evaluations of fitness and physical health, surveys, and study entry visits.
Participation in the study is expected to be about 24 weeks.
It is expected that about 20 people will take part in this research study
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
- •Age ≥18 years at time of diagnosis; due to the rarity of the disease in those <18 years, this age bracket will not be included.
- •Histologically diagnosed with stage II or III non-small cell lung cancer (NSCLC) and has not started lung cancer treatment.
- •Patient's treatment plan is to receive neoadjuvant therapy (defined as chemotherapy, chemotherapy and immunotherapy, or chemotherapy and radiation therapy) followed by surgical treatment. Patients will be enrolled at least three weeks prior to receiving their first neoadjuvant treatment.
- •Ability to follow directions and complete questionnaires in English and/or Spanish.
- •Ability to understand and the willingness to sign a written informed consent document prior to any study-related procedures.
- •Willing to travel to DFCI for necessary data collection.
排除标准
- •Patients who are morbidly obese (BMI>40 kg/m2) or Anorexic (BMI<17 kg/m2).
- •Unstable comorbidities that contraindicate participation in exercise program compliance. Patients with unstable comorbidities may develop unexpected adverse events from exercise. For the purpose of patients' safety, as well as because part of this study involves remote, home-based exercise where close supervision is not possible, patients with unstable medical conditions are excluded. Study staff will identify untreated or unmanaged conditions when screening and treating MDs must provide clearance prior to patient enrollment.
- •Patients with alcohol or drug abuse, significant mental or emotional problems that would interfere with compliance (assessed by NCCN Distress Thermometer).
- •Patients scheduled to receive single modality cancer treatment (unimodal therapy), scheduled surgery within 2 weeks of the pre-treatment clinic visit, or for whom treatment has already started.
- •Patients who are pregnant, or plan to become pregnant during study duration will be excluded due to the unknown nature of exercise on developing fetuses.
- •Subjects who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study.
研究组 & 干预措施
PERCC
Receives personalized virtual exercise program (aerobic and resistance exercise) 1x weekly for patients with lung cancer who plan on receiving neoadjuvant treatment followed by surgery.
干预措施: PERCC (Behavioral)
结局指标
主要结局
Attendance of Exercise Sessions (Feasibility)
时间窗: From first exercise session to final exercise session (up to 24 weeks)
Defined as the proportion of enrolled participants who complete ≥80% of the prescribed exercise sessions.
次要结局
未报告次要终点
研究者
Christina Dieli-Conwright, PhD
Principal Investigator
Dana-Farber Cancer Institute