A Remotely Supervised Exercise Program for Lung Cancer Patients Undergoing Chemoradiation
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Recruitment and retention statistics
研究概览
简要总结
The purpose of this study is to conduct a pilot randomized controlled trial (RCT) evaluating the feasibility and potential effectiveness of a remotely supervised exercise program (REM) in promoting adherence to an exercise prescription before and during chemoradiation.
详细描述
The research team adopts an overtly pragmatic approach where our design choices are made to enhance external validity and create a parsimonious intervention that can be integrated into busy clinical practices. This is a pilot study and is not designed to definitively provide evidence for a treatment effect, but rather to establish feasibility and to optimize the intervention and study procedures in preparation for a larger trial. We will conduct a pilot RCT comparing a remotely supervised exercise program (REM) to an unsupervised exercise program (UNSUP). Data will be collected upon enrollment (T0; at least 2 weeks prior to beginning chemoradiation), immediately prior to chemoradiation (T1), immediately post-chemoradiation (T2) and 1-month post-chemoradiation (T3).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Participants will be blind to study hypotheses, data collector will be blind to treatment assignment
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
- •Are over the age of 18 and diagnosed with Stage IIa to IIIb lung cancer;
- •Definitive treatment with chemoradiation with weekly carboplatin and paclitaxel concurrent with radiation is planned to begin in no less than 2 weeks;
- •Have an Apple or Android device with capacity to install a fitness device app and access to either WiFi or cellular service;
- •Are English-speaking and able to provide voluntary, written consent;
- •Able to tolerate chemoradiation as indicated by Zubrod/ECOG Performance Status 0-1; CBC/differential obtained within 14 days prior to registration on study, with adequate bone marrow function defined as follows: Absolute neutrophil count (ANC) ≥ 1,500 cells/mm3; Platelets ≥ 100,000 cells/mm3; Hemoglobin ≥ 8.0 g/dl;Adequate renal function within 14 days prior to registration, defined as creatinine clearance must be at least 35 ml/min; Adequate hepatic function within 14 days prior to registration, defined as total bilirubin ≤ 1.5 x upper limit of normal (ULN) for the institution and ALT, AST, and alkaline phosphatase ≤ 2.5 x ULN for the institution; No prior thoracic radiation therapy;
排除标准
- •Life expectancy of < 12 months or are receiving hospice services;
- •Psychiatric diagnosis that would require significant study modification to meet their needs such as uncontrolled severe mental illness, substance abuse, or active suicidal ideation;
- •Exhibit American College of Sports Medicine contraindications to exercise which include a resting heart rate of >120bpm, blood pressure >180/100mmHg or unstable angina 40 or musculoskeletal issue preventing exercise;
- •Are unable to walk 100 meters. According to our current standard of care, those participants will be referred to physical therapy for evaluation and treatment and will be excluded from the study as unsupervised exercise would not be safe;
- •Less than 2 weeks to the beginning of chemoradiation;
- •Physician discretion;
- •Are unable to walk or to complete the 6-minute walk test. According to our current standard of care, those participants will be referred to physical therapy for evaluation and treatment and will be excluded from the study as unsupervised exercise would not be safe.
研究组 & 干预措施
Unsupervised Exercise (UNSUP)
The control condition represents a minimalist intervention that could occur in any setting: (1) enthusiastic provision on an exercise prescription and (2) provision of a fitness device (i.e., the Garmin VivioActive) that can help participants track their exercise engagement. Participants are instructed in how to use the device to track their adherence to the exercise prescription.
干预措施: Unsupervised Exercise (UNSUP) (Behavioral)
Remotely Supervised Exercise (REM)
The REM program is designed to function as an Acceptance-based health coaching intervention and will utilize theory-based behavior change techniques (i.e., goal setting/action planning, self-monitoring, receiving feedback, and reviewing relevant goals in the light of feedback) to promote adoption and adherence to the exercise prescription.
干预措施: Remotely Supervised Exercise (REM) (Behavioral)
结局指标
主要结局
Recruitment and retention statistics
时间窗: Time 3, One month after completing chemoradiation
Number of participants enrolled/number of patients eligible; Number completing all data collection/Number enrolled; Number adhering to randomization/number enrolled; Number withdrawn/number enrolled
次要结局
- 6-minute walk test(Time 3, One month after completing chemoradiation)
- Minutes spent in exercise(Time 3, One month after completing chemoradiation)
- Timed up-and-go test(Time 3, One month after completing chemoradiation)
- Five times sit-to-stand test(Time 3, One month after completing chemoradiation)
- Forced expiratory volume in 1 second(Time 3, One month after completing chemoradiation)
- Diffusion capacity(Time 3, One month after completing chemoradiation)
- Physical Function Scale of the Patient Reported Outcomes Measurement information System (PROMIS)(Time 3, One month after completing chemoradiation)
- Pittsburgh Sleep Quality Index(Time 3, One month after completing chemoradiation)
- Dose reductions(Time 3, One month after completing chemoradiation)
- Grip strength(Time 3, one month after completing chemoradiation)
- Forced vital capacity(Time 3, One month after completing chemoradiation)
- Functional Assessment of Cancer Therapy-fatigue scale(Time 3, One month after completing chemoradiation)
研究者
Kathleen Lyons
Scientist, Psychiatry Research
Dartmouth-Hitchcock Medical Center