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A Series of Study in Testing Efficacy of Pulmonary Rehabilitation Interventions in Lung Cancer Survivors

Primary Purpose

Lung Cancer

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Home rehabilitation exercise program
Sponsored by
National Taipei University of Nursing and Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Lung Cancer focused on measuring lung cancer, early physical rehabilitation, muscle endurance, aerobic capacity, quality of life

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • National Taiwan University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

The intervention group

The control group

Arm Description

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.

Participants in the control group received regular medication education.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.

Full Information

First Posted
April 16, 2019
Last Updated
April 16, 2019
Sponsor
National Taipei University of Nursing and Health Sciences
Collaborators
Ministry of Science and Technology, Taiwan, National Taiwan University Hospital, Mackay Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03918538
Brief Title
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

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
September 9, 2015 (Actual)
Primary Completion Date
March 17, 2017 (Actual)
Study Completion Date
March 17, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Taipei University of Nursing and Health Sciences
Collaborators
Ministry of Science and Technology, Taiwan, National Taiwan University Hospital, Mackay Memorial Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
lung cancer, early physical rehabilitation, muscle endurance, aerobic capacity, quality of life

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
92 (Actual)

8. Arms, Groups, and Interventions

Arm Title
The intervention group
Arm Type
Experimental
Arm Description
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.
Arm Title
The control group
Arm Type
No Intervention
Arm Description
Participants in the control group received regular medication education.
Intervention Type
Behavioral
Intervention Name(s)
Home rehabilitation exercise program
Intervention Description
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.
Primary Outcome Measure Information:
Title
six-minute walk test
Description
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.
Time Frame
Change from Baseline to 6 months
Secondary Outcome Measure Information:
Title
30-second arm curl test
Description
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.
Time Frame
Change from Baseline to 6 months
Title
30-second chair sit-to-stand test
Description
To test leg strength and endurance. Record the number of stand a person can complete in 30 seconds.
Time Frame
Change from Baseline to 6 months
Title
Functional Assessment of Cancer Therapy-Lung (FACT-L)
Description
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.
Time Frame
Change from Baseline to 6 months
Title
The Functional Assessment of Chronic Illness Therapy-Fatigue
Description
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.
Time Frame
Change from Baseline to 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tsae Jyy Wang, PhD
Organizational Affiliation
National Taipei University of Nursing and Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
100
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
21663994
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.
Results Reference
background
PubMed Identifier
17582629
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.
Results Reference
background
PubMed Identifier
19258829
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.
Results Reference
background

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A Series of Study in Testing Efficacy of Pulmonary Rehabilitation Interventions in Lung Cancer Survivors

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