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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

92 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-09

Study Completion Date

2017-03-17

Brief Summary

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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.

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Detailed Description

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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

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Lung Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors

Study Groups

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The intervention group

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.

Group Type EXPERIMENTAL

Home rehabilitation exercise program

Intervention Type BEHAVIORAL

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.

The control group

Participants in the control group received regular medication education.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Home rehabilitation exercise program

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No