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

NCT05959265 | Unknown

• 1 other identifier: CAMDD-001
• Study Type: interventional
• Target: 180
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Exercise; psychological; clinical prognosis; advanced non-small cell lung cancer

Outcome Measures

Primary Outcomes (2)

• Anxiety

  Changes in anxiety scores measured through the Hospital Anxiety and Depression Scale

  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.

  3 months

Secondary Outcomes (6)

• Depression

  3 months

• Tumor biomarker

  3 months

• adiponectin

  3 months

• Inflammatory biomarker

  3 months

• OS (Overall Survival)

  1 year

Study Arms (2)

Arm1

EXPERIMENTAL

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.

Behavioral: exercise

Arm2

NO INTERVENTION

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.

Interventions

exercise BEHAVIORAL

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.

Arm1

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years old;
• Pathologically confirmed IIIB/IV stage NSCLC patients;
• According to the judgment of the researcher, it is suitable for enrollment;
• Can walk independently without assistance;
• The subjects voluntarily joined this study and signed an informed consent form, with good compliance and cooperation in follow-up.

You may not qualify if:

• Pregnant or lactating women;
• Severe active infection
• Unable to walk
• Cannot be active (more than two days)
• Severe neurological or cardiac damage
• Severe respiratory insufficiency
• Uncontrollable pain
• Those who have perceptual barriers or cognitive and Communication disorder and are unable to cooperate;
• Participated in other sports groups during the research period;
• According to the judgment of the researchers, the subjects may have other factors that may lead to the forced termination of this study, such as other serious illnesses (including mental illness) requiring concurrent treatment, serious laboratory test abnormalities, accompanied by family or social factors, which may affect the safety of the subjects, or the collection of data and samples;

Sponsors & Collaborators

• The First Affiliated Hospital of Guangzhou Medical University: lead

MeSH Terms

Conditions

Lung Neoplasms; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Jianxing He

  The First Affiliated Hospital of Guangzhou Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wenhua Liang

CONTACT

+8613710249454; liangwh1987@163.com

Jianxing He

CONTACT

+862083337792; drjianxing.he@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 17, 2023
• First Posted: July 25, 2023
• Study Start: August 1, 2023
• Primary Completion: August 1, 2024
• Study Completion: August 1, 2025
• Last Updated: July 25, 2023

Record last verified: 2023-07