This study is an open-label, prospective, two-arm clinical trial aimed at evaluating the impact of exercise therapy on the psychological state and clinical prognosis of advanced non-small cell lung cancer (NSCLC) patients. After signing the informed consent form, patients will be randomly assigned to either the treatment group or the control group. Enrolled patients will undergo both a treatment phase and a follow-up phase. Patients in the treatment group will undergo a 12-week intervention consisting of three 30-minute walking exercises per week during their standard cancer treatment. A personalized walking plan using fitness trackers will be provided to record each patient's daily average heart rate, step count, and additional steps and heart rate during the three 30-minute walking exercises per week to assess their activity levels. Weekly collaborations between the principal investigator and each participant will be conducted to assess step-related parameters.Additionally, the primary investigator of the study will conduct two investigator-led structured counseling sessions at the beginning of the project and midway through the intervention. These sessions will include a comprehensive assessment of the participant's lifestyle and current symptoms. Recommendations and counseling, such as symptom management, will be provided immediately following the investigator-led sessions and continuously throughout the study, along with appropriate referrals or contacts.Patients in the control group will receive standard cancer treatment and will not be instructed to avoid exercise. They will also be provided with fitness trackers to record their daily average heart rate and step count to evaluate their daily activity level. Furthermore, participants will be retrospectively asked about their physical activity during the intervention period at the end of the intervention phase.During the follow-up phase, researchers will provide appropriate treatment advice based on the patients' conditions. Completed study patients will undergo follow-up assessments every three months for one year.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
180
Patients in the treatment group will undergo a 12-week intervention consisting of three 30-minute walking exercises per week during their standard cancer treatment. A personalized walking plan using fitness trackers will be provided to record each patient's daily average heart rate, step count, and additional steps and heart rate during the three 30-minute walking exercises per week to assess their activity levels. Weekly collaborations between the principal investigator and each participant will be conducted to assess step-related parameters.
Anxiety
Changes in anxiety scores measured through the Hospital Anxiety and Depression Scale
Time frame: 3 months
ORR (Objective Response Rate)
ORR (Objective Response Rate) is defined as the proportion of participants who confirmed at least one CR (Complete Response) or PR (Partial response) before disease progression based on Response Evaluation Criteria in Solid Tumors (RECIST)1.1 as assessed by the investigator.
Time frame: 3 months
Depression
Changes in depression scores measured through the Hospital Anxiety and Depression Scale
Time frame: 3 months
Tumor biomarker
NSE、CEA、CA125、CA153、CYFRA21-1、SCC
Time frame: 3 months
adiponectin
It is an endogenous bioactive peptide or protein secreted by adipocytes
Time frame: 3 months
Inflammatory biomarker
PCT、CRP、TNF、IL-6、IL-8 和 IL-2, IL-13, IL-18
Time frame: 3 months
OS (Overall Survival)
OS (Overall Survival) is defined as the time from the initial administration of treatment to the date of death due to any cause. Patients who have not died at the time of statistical analysis will have their survival time censored at the last known date of their survival.
Time frame: 1 year
PFS (Progression-Free Survival)
PFS (Progression-Free Survival) is defined as the time between the onset of randomization and the occurrence (progression) or death (for any reason) of the tumor
Time frame: 1 year
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