The Effect of Interventional Pulmonary Rehabilitation Exercise With Advanced Lung Cancer.

The Effect of Interventional Pulmonary Rehabilitation Exercise on the Psychological Distress, Self-efficacy, and Quality of Life of Patients With Advanced Lung Cancer.

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Quality of Life; Lung Neoplasms; Lung Cancer; Exercise; Lung Adenocarcinoma; Psychological Distress; Pulmonary Rehabilitation; Self Efficacy; Advanced Lung Cancer; Lung Tumor
• Intervention / Treatment: Behavioral: pulmonary rehabilitation exercise

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.

• Study Type: Interventional
• Enrollment (Anticipated): 104
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Wei-Ling LIU, Postgraduate; Phone Number: 0912768628; Email: m50929g@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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].

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: FACTORIAL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Experimental group; Mandatory exercise the lung rehabilitation exercise is divided into three parts: upper and lower limb muscle strength, endurance training and breathing training skills. It lasts for eight weeks of exercise training, and the exercise frequency is: three times a week.	Behavioral: pulmonary rehabilitation exercise; The lung rehabilitation exercise is divided into three parts: upper and lower limb muscle strength, endurance training and breathing training skills. It lasts for eight weeks of exercise training, and the exercise frequency is: three times a week.; Other Names: exercise
NO_INTERVENTION: Control group; Voluntary exercise the lung rehabilitation exercise is divided into three parts: upper and lower limb muscle strength, endurance training and breathing training skills. It lasts for eight weeks of exercise training, and the exercise frequency is: three times a week.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
psychological distress	Hospital Anxiety and Depression Scale , HADS .There are 14 items in this scale, including 7 items for anxiety and 7 items for depression. Each item has 4 options and is scored from 0 to 3. The higher the score, the higher the degree of anxiety or depression. Because the question does not contain physical symptoms, but emotional states, it is more likely to avoid false positives caused by cancer symptoms, so it is widely used in emotional evaluation and screening of cancer patients. A score higher than 9 in the anxiety section, or a score higher than 8 in the depression section, or a total score higher than 15 requires clinical attention.	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).
self-efficacy	General Self-Efficacy Scale,GSES.The GSES is a 10-item psychometric scale with scores for each item ranging from 1 (not completely correct) to 4 (including completely correct). Scores range from 10 to 40, with the highest score indicating higher self-efficacy.	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).
quality of life Functional Assessment of Cancer Therapy-Lung	Functional Assessment of Cancer Therapy-Lung,FACT-L.FACT-L, Version 4, is a combination of the 27-item FACT-General (FACT-G) and the 9-item Lung Cancer Subscale (LCS) Items include: physical health status, social/family health status, emotional stability status, Functional health status, additional concerns, lung cancer-related issues, the score ranges from 0 to 4, and the higher the final value, the higher the score on the scale, and the better the quality of life.	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
6MWT	Six-minute Walking Test	baseline (T1) and 8 weeks after the intervention program (T4).
maximum strength training test	maximum strength training test	baseline (T1) and 8 weeks after the intervention program (T4).

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): March 20, 2022
• Primary Completion (ANTICIPATED): February 15, 2023
• Study Completion (ANTICIPATED): December 30, 2024

Study Registration Dates

• First Submitted: February 16, 2022
• First Submitted That Met QC Criteria: March 6, 2022
• First Posted (ACTUAL): March 15, 2022

Study Record Updates

• Last Update Posted (ACTUAL): March 15, 2022
• Last Update Submitted That Met QC Criteria: March 6, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms by Histologic Type; Neoplasms; Lung Diseases; Neoplasms by Site; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Adenocarcinoma of Lung
• Other Study ID Numbers: 202103103RIND

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No