Lung CancerNCT03918538
A Series of Study in Testing Efficacy of Pulmonary Rehabilitation Interventions in Lung Cancer Survivors
A study testing Home rehabilitation exercise program in people with Lung Cancer, run by National Taipei University of Nursing and Health Sciences at 1 site in Taiwan.
Trial summary
Aim: To develop and testing a home exercise program for lung cancer survivors to improve their exercise tolerance and quality of life during the rehabilitation phase. Design: An experimental design will be used in the study. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Home rehabilitation exercise program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteTaiwan
- Study dates
- 9 Sep 2015to 17 Mar 2017
- 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
- aged 20 and older,
- diagnosed with stage I-IIIB non-small cell lung cancer
- completed initial cancer treatments and no planned cancer treatment in three months
- Karnofsdy Performance Status equal or greater then 50
- estimated survival time greater than six months
- with the permission of the patient's physician
Who cannot join
- having a medical condition precluding exercise (i.e. uncontrolled arrhythmias, uncontrolled hypertension, third-degree heart block, myocardial infarction within six months, unstable angina, acute congestive heart failure and taking anticoagulation for valve diseases).
- poor controlled diabetics (HbA1C>9%)
- regularly exercising in moderate or higher intensity three time a week within three month
- unable to walk independently
- unable to communicate
Trial locations and contacts
1 site in 1 country.
About this study
Aim: To develop and testing a home exercise program for lung cancer survivors to improve their exercise tolerance and quality of life during the rehabilitation phase.
Design: An experimental design will be used in the study. The 90 lung cancer survivors, who were diagnosed with lung cancer within one year and have completed their initial cancer treatment, will be recruited and randomized to the control or intervention group. After pre-test, the intervention participants will receive a 60 minutes of teaching regarding the home rehabilitation exercise program, with a printed exercise manual. The intervention participant will also receive a weekly phone call from the interventionist to enhance their exercise adherence and helping to overcome exercise barriers. The similar outcome measures as study one will be assessed on the baseline, 1th month, 3th month, and 6th month.
Read more
Measurements: The study outcomes will be evaluated by three physical measures, six-minute walk test, Modified Borg Scale, 30-second Chair Sit-to-Stand Test, and 30-second Chair Sit-to-Stand Test, as well as a study questionnaire including Functional Assessment of Cancer Therapy-Lung (FACT-L) and FACIT-Fatigue. For study one the following data will be collected from the patient'schart: post-operative pulmonary complications, days of chest tube insertion, and days of hospitalization.
Data analysis: Descriptive analysis will be used to describe patients'demongraphics, disease variables, and outcome variables. The Chi-square, T-test, and General Linear Mix-effect Model will be used to test the efficacy of the study interventions.
Read the detailed description
Background: With appropriate treatment, lung cancer patients can be a long-term survivor. However, many patients suffered from post-operative pulmonary complications, limited activity tolerance, and poor quality of life. Nurses in a great position to provide individualized health education regarding exercise for these patients; therefore to develop and test cost-effective nurses-lead lung rehabilitation exercise education programs deserver further scientific efforts.
Aim: To develop and testing a home exercise program for lung cancer survivors to improve their exercise tolerance and quality of life during the rehabilitation phase.
Design: An experimental design will be used in the study. The 90 lung cancer survivors, who were diagnosed with lung cancer within one year and have completed their initial cancer treatment, will be recruited and randomized to the control or intervention group. After pre-test, the intervention participants will receive a 60 minutes of teaching regarding the home rehabilitation exercise program, with a printed exercise manual. The intervention participant will also receive a weekly phone call from the interventionist to enhance their exercise adherence and helping to overcome exercise barriers. The similar outcome measures as study one will be assessed on the baseline, 1th month, 3th month, and 6th month.
Measurements: The study outcomes will be evaluated by three physical measures, six-minute walk test, Modified Borg Scale, 30-second Chair Sit-to-Stand Test, and 30-second Chair Sit-to-Stand Test, as well as a study questionnaire including Functional Assessment of Cancer Therapy-Lung (FACT-L) and FACIT-Fatigue. For study one the following data will be collected from the patient'schart: post-operative pulmonary complications, days of chest tube insertion, and days of hospitalization.
Data analysis: Descriptive analysis will be used to describe patients'demongraphics, disease variables, and outcome variables. The Chi-square, T-test, and General Linear Mix-effect Model will be used to test the efficacy of the study interventions.
Significance: The study results will provide evidence for the efficacy of pulmonary rehabilitation and a home exercise program for enhancing exercise tolerance and quality of life in lung cancer survivors.
- Conditions
- Lung Cancer
- Being tested
- Home rehabilitation exercise program
- Keywords
- lung cancer, early physical rehabilitation, muscle endurance, aerobic capacity, quality of life
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home rehabilitation exercise programBehavioural
After pre-test, the intervention participants received a 60 minutes of teaching regarding the home rehabilitation exercise program, with a printed exercise manual. The intervention participants also received a weekly phone call from the interventionist to enhance their exercise adherence and helping to overcome exercise barriers.
| Study group | Role | What they receive |
|---|---|---|
| The intervention group | Experimental | After pre-test, the intervention participants received a 60 minutes of teaching regarding the home rehabilitation exercise program, with a printed exercise manual.
The intervention participants also received a weekly phone call from the interventionist to enhance their exercise adherence and helping to overcome exercise barriers. Receives: Behavioral: Home rehabilitation exercise program |
| The control group | No intervention | Participants in the control group received regular medication education. |
What is being measured
The primary outcome is the main question the study is designed to answer.
six-minute walk test
The six-minute walk test measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. The goal is for the individual to walk as far as possible in six minutes. The individual is allowed to self-pace and rest as needed as they traverse back and forth along a marked walkway.
Measured: Change from Baseline to 6 months
Secondary outcomes (4)
30-second arm curl test
To measure upper body strength and endurance. The participant is sitting on the edge of a stabile chair, with seat height of 44 cm (originally 43.18 cm). The back is outstretched, the feet resting flat on the ground. A handle weighing 2 kg for women or 3.5 kg for men is held in the dominant hand. The arm is directed downwards, along the chair, perpendicularly to the floor. Participant's task is, at a command given by the testing person, to rotate the hand upwards while simultaneously flexing the extremity in the elbow (flexion with supination), and subsequently to extend the extremity to its baseline position.
Measured: Change from Baseline to 6 months
30-second chair sit-to-stand test
To test leg strength and endurance. Record the number of stand a person can complete in 30 seconds.
Measured: Change from Baseline to 6 months
Functional Assessment of Cancer Therapy-Lung (FACT-L)
There are two subscales, 27 items of FACT-General and 9 items of Lung Cancer Subscale. Each item is rated on a 5-point Likert scale (0-4). The total score of the 36 items represents the score of the scale. The higher values represent better quality of life.
Measured: Change from Baseline to 6 months
The Functional Assessment of Chronic Illness Therapy-Fatigue
There are 13 items in the scale. Each item is rated on a 5-point Likert scale (0-4). The total score of the 13 items represents the score of the scale. The possible score for the scale ranges from 0 to 52. The higher values represent more fatigue.
Measured: Change from Baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2019
- Study start9 Sep 2015
- Primary completion17 Mar 2017
- Study completion17 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- 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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taipei University of Nursing and Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Science and Technology, Taiwan, National Taiwan University Hospital, Mackay Memorial Hospital
- Responsible party
- Principal investigator, Tsae Jyy, Wang, National Taipei University of Nursing and Health Sciences
- Investigators
- Tsae Jyy Wang, PhD, Principal investigator, National Taipei University of Nursing and Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03918538
- Sponsor's protocol ID
- 13MMHIS305
- Status last verified
- Apr 2019
- First submitted
- 16 Apr 2019
- Last updated
- 17 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Benzo R, Wigle D, Novotny P, Wetzstein M, Nichols F, Shen RK, Cassivi S, Deschamps C. Preoperative pulmonary rehabilitation before lung cancer resection: results from two randomized studies. Lung Cancer. 2011 Dec;74(3):441-5. doi: 10.1016/j.lungcan.2011.05.011. Epub 2011 Jun 12.
PubMed 21663994Jones LW, Peddle CJ, Eves ND, Haykowsky MJ, Courneya KS, Mackey JR, Joy AA, Kumar V, Winton TW, Reiman T. Effects of presurgical exercise training on cardiorespiratory fitness among patients undergoing thoracic surgery for malignant lung lesions. Cancer. 2007 Aug 1;110(3):590-8. doi: 10.1002/cncr.22830.
PubMed 17582629Peddle CJ, Jones LW, Eves ND, Reiman T, Sellar CM, Winton T, Courneya KS. Effects of presurgical exercise training on quality of life in patients undergoing lung resection for suspected malignancy: a pilot study. Cancer Nurs. 2009 Mar-Apr;32(2):158-65. doi: 10.1097/NCC.0b013e3181982ca1.
PubMed 19258829
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Series of Study in Testing Efficacy of Pulmonary Rehabilitation Interventions in Lung Cancer Survivors
- ClinicalTrials.gov ID
- NCT03918538
- Acronym / sponsor ID
- 13MMHIS305
- Conditions
- Lung Cancer
- Keywords
- lung cancer, early physical rehabilitation, muscle endurance, aerobic capacity, quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- National Taipei University of Nursing and Health SciencesUniversity, hospital or other
- Collaborators
- Ministry of Science and Technology, Taiwan, National Taiwan University Hospital, Mackay Memorial Hospital
- Study start
- 9 Sep 2015 (actual)
- Primary completion
- 17 Mar 2017 (actual)
- Study completion
- 17 Mar 2017 (actual)
- First posted
- 17 Apr 2019 (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.
Aim: To develop and testing a home exercise program for lung cancer survivors to improve their exercise tolerance and quality of life during the rehabilitation phase.
Design: An experimental design will be used in the study. The 90 lung cancer survivors, who were diagnosed with lung cancer within one year and have completed their initial cancer treatment, will be recruited and randomized to the control or intervention group. After pre-test, the intervention participants will receive a 60 minutes of teaching regarding the home rehabilitation exercise program, with a printed exercise manual. The intervention participant will also receive a weekly phone call from the interventionist to enhance their exercise adherence and helping to overcome exercise barriers. The similar outcome measures as study one will be assessed on the baseline, 1th month, 3th month, and 6th month.
Measurements: The study outcomes will be evaluated by three physical measures, six-minute walk test, Modified Borg Scale, 30-second Chair Sit-to-Stand Test, and 30-second Chair Sit-to-Stand Test, as well as a study questionnaire including Functional Assessment of Cancer Therapy-Lung (FACT-L) and FACIT-Fatigue. For study one the following data will be collected from the patient'schart: post-operative pulmonary complications, days of chest tube insertion, and days of hospitalization.
Data analysis: Descriptive analysis will be used to describe patients'demongraphics, disease variables, and outcome variables. The Chi-square, T-test, and General Linear Mix-effect Model will be used to test the efficacy of the study interventions.
Detailed description
Background: With appropriate treatment, lung cancer patients can be a long-term survivor. However, many patients suffered from post-operative pulmonary complications, limited activity tolerance, and poor quality of life. Nurses in a great position to provide individualized health education regarding exercise for these patients; therefore to develop and test cost-effective nurses-lead lung rehabilitation exercise education programs deserver further scientific efforts.
Aim: To develop and testing a home exercise program for lung cancer survivors to improve their exercise tolerance and quality of life during the rehabilitation phase.
Design: An experimental design will be used in the study. The 90 lung cancer survivors, who were diagnosed with lung cancer within one year and have completed their initial cancer treatment, will be recruited and randomized to the control or intervention group. After pre-test, the intervention participants will receive a 60 minutes of teaching regarding the home rehabilitation exercise program, with a printed exercise manual. The intervention participant will also receive a weekly phone call from the interventionist to enhance their exercise adherence and helping to overcome exercise barriers. The similar outcome measures as study one will be assessed on the baseline, 1th month, 3th month, and 6th month.
Measurements: The study outcomes will be evaluated by three physical measures, six-minute walk test, Modified Borg Scale, 30-second Chair Sit-to-Stand Test, and 30-second Chair Sit-to-Stand Test, as well as a study questionnaire including Functional Assessment of Cancer Therapy-Lung (FACT-L) and FACIT-Fatigue. For study one the following data will be collected from the patient'schart: post-operative pulmonary complications, days of chest tube insertion, and days of hospitalization.
Data analysis: Descriptive analysis will be used to describe patients'demongraphics, disease variables, and outcome variables. The Chi-square, T-test, and General Linear Mix-effect Model will be used to test the efficacy of the study interventions.
Significance: The study results will provide evidence for the efficacy of pulmonary rehabilitation and a home exercise program for enhancing exercise tolerance and quality of life in lung cancer survivors.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The intervention group | Experimental | Behavioral: Home rehabilitation exercise programAfter pre-test, the intervention participants received a 60 minutes of teaching regarding the home rehabilitation exercise program, with a printed exercise manual. The intervention participants also received a weekly phone call from the interventionist to enhance their exercise adherence and helping to overcome exercise barriers. |
| The control group | No intervention | –Participants in the control group received regular medication education. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- aged 20 and older,
- diagnosed with stage I-IIIB non-small cell lung cancer
- completed initial cancer treatments and no planned cancer treatment in three months
- Karnofsdy Performance Status equal or greater then 50
- estimated survival time greater than six months
Key exclusion criteria (5 listed)
- having a medical condition precluding exercise (i.e. uncontrolled arrhythmias, uncontrolled hypertension, third-degree heart block, myocardial infarction within six months, unstable angina, acute congestive heart failure and taking anticoagulation for valve diseases).
- poor controlled diabetics (HbA1C>9%)
- regularly exercising in moderate or higher intensity three time a week within three month
- unable to walk independently
- unable to communicate
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 |
|---|---|---|
| Home rehabilitation exercise programAfter pre-test, the intervention participants received a 60 minutes of teaching regarding the home rehabilitation exercise program, with a printed exercise manual. The intervention participants also received a weekly phone call from the interventionist to enhance their exercise adherence and helping to overcome exercise barriers. | Behavioural | The intervention group |
Primary outcome
six-minute walk test
Time frame: Change from Baseline to 6 months
The six-minute walk test measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. The goal is for the individual to walk as far as possible in six minutes. The individual is allowed to self-pace and rest as needed as they traverse back and forth along a marked walkway.
4 secondary outcomes
30-second arm curl test
Time frame: Change from Baseline to 6 months
30-second chair sit-to-stand test
Time frame: Change from Baseline to 6 months
Functional Assessment of Cancer Therapy-Lung (FACT-L)
Time frame: Change from Baseline to 6 months
The Functional Assessment of Chronic Illness Therapy-Fatigue
Time frame: Change from Baseline to 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2019.
- Background: PubMed 21663994Benzo R, Wigle D, Novotny P, Wetzstein M, Nichols F, Shen RK, Cassivi S, Deschamps C. Preoperative pulmonary rehabilitation before lung cancer resection: results from two randomized studies. Lung Cancer. 2011 Dec;74(3):441-5. doi: 10.1016/j.lungcan.2011.05.011. Epub 2011 Jun 12.
- Background: PubMed 17582629Jones LW, Peddle CJ, Eves ND, Haykowsky MJ, Courneya KS, Mackey JR, Joy AA, Kumar V, Winton TW, Reiman T. Effects of presurgical exercise training on cardiorespiratory fitness among patients undergoing thoracic surgery for malignant lung lesions. Cancer. 2007 Aug 1;110(3):590-8. doi: 10.1002/cncr.22830.
- Background: PubMed 19258829Peddle CJ, Jones LW, Eves ND, Reiman T, Sellar CM, Winton T, Courneya KS. Effects of presurgical exercise training on quality of life in patients undergoing lung resection for suspected malignancy: a pilot study. Cancer Nurs. 2009 Mar-Apr;32(2):158-65. doi: 10.1097/NCC.0b013e3181982ca1.
- 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.
Tsae Jyy Wang, PhD principal investigator
National Taipei University of Nursing and Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home rehabilitation exercise program in people with Lung Cancer, run by National Taipei University of Nursing and Health Sciences at 1 site in Taiwan.
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 6 inclusion and 5 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: finished, as of the sponsor's last update on 17 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
six-minute walk test (time frame: Change from Baseline to 6 months). 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 NCT03918538, which also lists 3 linked publications.
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 17 Apr 2019.