Clinical trial NCT05279521: The Effect of Interventional Pulmonary Rehabilitation Exercise With Advanced Lung Cancer.
Official title: The Effect of Interventional Pulmonary Rehabilitation Exercise on the Psychological Distress, Self-efficacy, and Quality of Life of Patients With Advanced Lung Cancer.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lung Cancer
Pulmonary Rehabilitation
Exercise
Lung Adenocarcinoma
Lung Tumor
Lung Neoplasms
Advanced Lung Cancer
Self Efficacy
Quality of Life
Psychological Distress
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2022-03-15
Enrollment: 104
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study concluded that lung rehabilitation exercise programs can improve the psychological distress, self-efficacy, quality of life, six-minute walk distance, muscle strength, and reduce the number of hospitalizations for patients with advanced lung cancer.

Detailed description: Lung cancer is the top ten cause of cancer death in Taiwan. Since symptoms in the early stage are insidious, most patients are diagnosed in the advanced stage.

Chemotherapy and radiotherapy are often necessary because most of the advanced stage lung cancer has metastasized and multi-organ involved. The prolonged treatment course and side effects of the chemotherapy and radiotherapy, as long as the low survival rate, all impaired the quality of life. Recent studies have shown that exercise can improve the quality of life of cancer patients; therefore, the purpose of this study is to explore the effects of interventional lung rehabilitation exercises on psychological distress, self-efficacy and quality of life in patients with advanced lung cancer. The research is an interventional study. For the experimental group, lung rehabilitation exercise programs, including endurance training, muscle strength training and breathing training, were given; for the control group, a leaflet for lung rehabilitation exercise were provided. Random allocation software was used to randomly allocate cases to the experimental group and the control group. The patients were enrolled from the ward of the Department of Thoracic Medicine in a teaching hospital in north Taiwan. The estimated number of enrollment was 104. The structured questionnaire was used for data collection and analysis. The questionnaire contained 4 dimensions, including basic demographic characteristics, anxiety and depression scale, self-efficacy scale and quality of life scale. The data were collected at 4 time points; before the intervention (baseline measurement, T1), 4 weeks after the intervention (T2), 6 weeks after the intervention (T3), and 8 weeks after the intervention program (T4). At the same time, the six-minute walking distance and maximum strength training test of each case were measured at the baseline (T1) and 8 weeks after the intervention program (T4). We used the independent sample test,chi square test , Pearson correlation coefficient analysis and single-factor analysis of variance, and the generalized estimation equation for analysis of the psychological distress, self-efficacy, and quality of life between the two groups. This study concluded that lung rehabilitation exercise programs can improve the psychological distress, self-efficacy, quality of life, six-minute walk distance, muscle strength, and reduce the number of hospitalizations for patients with advanced lung cancer.

Eligibility criteria: Inclusion Criteria:

* Patients older than 20 years old, diagnosed with advanced lung cancer of stage III and IV lung cancer, and the Eastern Cooperative Oncology Group (ECOG) score of 0 and 1 points.
* Plans to receive treatment or has received treatment, including chemotherapy, targeted therapy, radiation therapy, or combination therapy.
* Those who agree to participate in the research and accept regular follow-up interviews and fill in the written consent form after explaining and explaining the research process and rights in detail.

Exclusion Criteria:

* Those who are unaware or have cognitive impairment who cannot accept the questionnaire interview.
* Unstable angina, arrhythmia, myocardial infarction diagnosis.
* History of epilepsy.
* Heart failure \[New York Heart Association, NYHA class IV\].

Primary outcomes:
measure: psychological distress
timeFrame: The data were collected at 4 time points; before the intervention (baseline measurement, T1), 4 weeks after the intervention (T2), 6 weeks after the intervention (T3), and 8 weeks after the intervention program (T4).
measure: self-efficacy
timeFrame: The data were collected at 4 time points; before the intervention (baseline measurement, T1), 4 weeks after the intervention (T2), 6 weeks after the intervention (T3), and 8 weeks after the intervention program (T4).
measure: quality of life Functional Assessment of Cancer Therapy-Lung
timeFrame: The data were collected at 4 time points; before the intervention (baseline measurement, T1), 4 weeks after the intervention (T2), 6 weeks after the intervention (T3), and 8 weeks after the intervention program (T4).
Secondary outcomes:
measure: 6MWT
timeFrame: baseline (T1) and 8 weeks after the intervention program (T4).
measure: maximum strength training test
timeFrame: baseline (T1) and 8 weeks after the intervention program (T4).
Other outcomes:
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