NCT05959265

Effect of Exercise Therapy on Psychological State and Clinical Prognosis of Advanced Non-small Cell Lung Cancer

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 180 (estimated)
• Sponsor: The First Affiliated Hospital of Guangzhou Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Lung Cancer

Interventions

Type	Name	Description
BEHAVIORAL	exercise	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.

Timeline

• Start date: 2023-08-01
• Primary completion: 2024-08-01
• Completion: 2025-08-01
• First posted: 2023-07-25
• Last updated: 2023-07-25