Assessing the Feasibility of a Patient-centered Activity Regimen in Patients With Advanced Stage Lung Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Number of Weeks Participants Adhered to Step Count Recommendations
研究概览
简要总结
The investigators will evaluate the feasibility of implementing a low-intensity, patient-centered activity regimen (PCAR) that prioritizes education and communication over a 12-week period in advanced stage lung cancer patients. The primary outcomes will include number of patients increasing their overall step count over the study period and adherence to step count recommendations. Secondary outcomes will include quality of life (QoL), dyspnea, and depression scores before and after the intervention as well as a patient feedback questionnaire (to guide further interventions). The goals are to increase overall step count and obtain adherence of >50% of participants. The investigators will also assess whether the physical activity regimen influences markers of inflammation and glucose control and novel markers of cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pathologic evidence of advanced non-small cell stage lung cancer (NSCLC)
- •Approval of the treating clinician
- •Adult patients (age >21 years) willing to wear a FitBit® device (FitBit, Inc., San Francisco, CA)
- •Access to a smartphone, agree to receive twice/daily text messages for 12 weeks (including any costs), and willingness to download the FitBit application to their smartphone.
- •Low activity level as judged by a brief physical activity questionnaire (i.e., <150 minutes/week of moderate-intensity exercise, <75 minutes/week of vigorous aerobic exercise, or an equivalent combination).
排除标准
- •Memory impairment (as judged by the treating clinician)
- •Communication impairment (as judged by the treating clinician)
- •Treating clinician's request not to alter physical activity
- •Physical inability to safely walk (as judged by the treating clinician)
结局指标
主要结局
Number of Weeks Participants Adhered to Step Count Recommendations
时间窗: baseline to 12 weeks.
Exercise Adherence will be defined as (the number of weeks a subject follows the activity prescription)/(the number of "usable" weeks). A week is considered "usable" if 5/7 days of step counts are available, and days with \<200 steps/day are considered not usable.
Overall Step Count
时间窗: baseline to 12 weeks
Participants will wear a Fitbit wrist band that will record step count.
次要结局
- Change in Quality of Life: Nausea/Vomiting(change from pre- to post-intervention (week 12))
- Change in Quality of Life: Pain(change from pre- to post-intervention (week 12))
- Dyspnea(change from pre- to post-intervention (week 12))
- Depression(change from pre- to post-intervention (week 12))
- Change in Quality of Life: Global Health Status(change from pre- to post-intervention (week 12))
- Change in Quality of Life: Role Functioning(change from pre- to post-intervention (week 12))
- Change in Quality of Life: Emotional Functioning(change from pre- to post-intervention (week 12))
- Change in Quality of Life: Fatigue(change from pre- to post-intervention (week 12))
- Change in Quality of Life: Physical Functioning(change from pre- to post-intervention (week 12))
- Change in Quality of Life: Cognitive Functioning(change from pre- to post-intervention (week 12))
- Change in Quality of Life: Social Functioning(change from pre- to post-intervention (week 12))
- Change in Quality of Life: Dyspnea(change from pre- to post-intervention (week 12))
- Change in Quality of Life: Insomnia(change from pre- to post-intervention (week 12))
- Change in Quality of Life: Appetite Loss(change from pre- to post-intervention (week 12))
- Change in C-reactive Protein (CRP)(change from pre- to post-intervention (week 12))
- Change in Quality of Life: Constipation(change from pre- to post-intervention (week 12))
- Vigorous Aerobic Exercise(baseline to 12 weeks)
- Change in Quality of Life: Diarrhea(change from pre- to post-intervention (week 12))
- Moderate Aerobic Exercise(baseline to 12 weeks)
- Change in Leptin Level(change from pre- to post-intervention (week 12))
- Change in Insulin Level(change from pre- to post-intervention (week 12))
- Programmed Death - Ligand(change from pre- to post-intervention (week 12))
- Change in Quality of Life: Financial Difficulties(change from pre- to post-intervention (week 12))
- Programmed Cell Death (PD-1)(change from pre- to post-intervention (week 12))