Lung CancerNCT05279521
The Effect of Interventional Pulmonary Rehabilitation Exercise With Advanced Lung Cancer.
A study testing pulmonary rehabilitation exercise in people with Lung Cancer and Pulmonary Rehabilitation, run by National Taiwan University Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Lung Cancer, Pulmonary Rehabilitation, Exercise
- What is being tested?
- pulmonary rehabilitation exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- No sites listed yet
- Study dates
- 20 Mar 2022to 30 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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].
Trial locations and contacts
No sites are listed yet.
About this study
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.
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.
Read the 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.
- Conditions
- Lung Cancer, Pulmonary Rehabilitation, Exercise, Lung Adenocarcinoma, Lung Tumor, Lung Neoplasms
- Being tested
- pulmonary rehabilitation exercise
- Medical subject headings
- Lung Neoplasms, Motor Activity, Adenocarcinoma of Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pulmonary rehabilitation exerciseBehavioural
Also called 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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | 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. Receives: Behavioral: pulmonary rehabilitation exercise |
| Control group | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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 (2)
6MWT
Six-minute Walking Test
Measured: baseline (T1) and 8 weeks after the intervention program (T4).
maximum strength training test
maximum strength training test
Measured: baseline (T1) and 8 weeks after the intervention program (T4).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2022
- Study start20 Mar 2022 (estimated)
- Primary completion15 Feb 2023 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05279521
- Sponsor's protocol ID
- 202103103RIND
- Status last verified
- Feb 2022
- First submitted
- 16 Feb 2022
- Last updated
- 15 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Liu WL, Chien JY, Lu YY, Liu KF. Nurse-supported hybrid home-based pulmonary rehabilitation improves psychological distress, quality of life, and functional performance in advanced lung cancer: A randomized controlled trial. Eur J Oncol Nurs. 2026 Apr;81:103130. doi: 10.1016/j.ejon.2026.103130. Epub 2026 Feb 5.
PubMed 41666769
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05279521
- Acronym / sponsor ID
- 202103103RIND
- Conditions
- Lung Cancer, Pulmonary Rehabilitation, Exercise, Lung Adenocarcinoma, Lung Tumor, Lung Neoplasms
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 20 Mar 2022 (estimated)
- Primary completion
- 15 Feb 2023 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 15 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Behavioral: pulmonary rehabilitation exerciseMandatory 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. |
| Control group | No intervention | –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. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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].
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pulmonary rehabilitation exerciseAlso: exerciseThe 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. | Behavioural | Experimental group |
Primary outcome
psychological distress
Time frame: 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).
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.
self-efficacy
Time frame: 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).
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.
quality of life Functional Assessment of Cancer Therapy-Lung
Time frame: 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).
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.
2 secondary outcomes
6MWT
Time frame: baseline (T1) and 8 weeks after the intervention program (T4).
maximum strength training test
Time frame: baseline (T1) and 8 weeks after the intervention program (T4).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2022.
- Derived from this study: PubMed 41666769Liu WL, Chien JY, Lu YY, Liu KF. Nurse-supported hybrid home-based pulmonary rehabilitation improves psychological distress, quality of life, and functional performance in advanced lung cancer: A randomized controlled trial. Eur J Oncol Nurs. 2026 Apr;81:103130. doi: 10.1016/j.ejon.2026.103130. Epub 2026 Feb 5.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing pulmonary rehabilitation exercise in people with Lung Cancer and Pulmonary Rehabilitation, run by National Taiwan University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wei-Ling LIU, Postgraduate (0912768628, m50929g@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
psychological distress (time frame: 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).). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05279521, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2022.