Clinical trial NCT03918538: A Series of Study in Testing Efficacy of Pulmonary Rehabilitation Interventions in Lung Cancer Survivors
Official title: A Series of Study in Testing Efficacy of Pulmonary Rehabilitation Interventions in Lung Cancer Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Cancer
Keywords: lung cancer
early physical rehabilitation
muscle endurance
aerobic capacity
quality of life
Lead sponsor: National Taipei University of Nursing and Health Sciences
Sponsor class: OTHER
Collaborators: name: Ministry of Science and Technology, Taiwan
name: National Taiwan University Hospital
name: Mackay Memorial Hospital
First posted: 2019-04-17
Enrollment: 92
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

1. aged 20 and older,
2. diagnosed with stage I-IIIB non-small cell lung cancer
3. completed initial cancer treatments and no planned cancer treatment in three months
4. Karnofsdy Performance Status equal or greater then 50
5. estimated survival time greater than six months
6. with the permission of the patient's physician

Exclusion Criteria:

1. 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).
2. poor controlled diabetics (HbA1C\>9%)
3. regularly exercising in moderate or higher intensity three time a week within three month
4. unable to walk independently
5. unable to communicate

Primary outcomes:
measure: six-minute walk test
timeFrame: Change from Baseline to 6 months
Secondary outcomes:
measure: 30-second arm curl test
timeFrame: Change from Baseline to 6 months
measure: 30-second chair sit-to-stand test
timeFrame: Change from Baseline to 6 months
measure: Functional Assessment of Cancer Therapy-Lung (FACT-L)
timeFrame: Change from Baseline to 6 months
measure: The Functional Assessment of Chronic Illness Therapy-Fatigue
timeFrame: Change from Baseline to 6 months
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taipei University of Nursing and Health Sciences
name: Tsae Jyy Wang, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Jones 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.
citation: Peddle 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.