S0229, Pulmonary Rehabilitation Education w/wo Exercise Training in Improving Physical Function in Patients Who Are Undergoing Chemo & RT for Locally Advanced Lung Cancer

Not Applicable

Terminated

• Conditions: Lung Cancer; Pulmonary Complications

• Registration Number: NCT00090961
• Lead Sponsor: SWOG Cancer Research Network

Brief Summary

RATIONALE: Pulmonary rehabilitation education and exercise training may improve physical function and quality of life in patients who are receiving treatment for lung cancer.

PURPOSE: This randomized clinical trial is studying pulmonary rehabilitation education and exercise training to see how well they work compared to exercise training alone in improving physical function and quality of life in patients who are undergoing chemotherapy and radiation therapy for locally advanced lung cancer.

Detailed Description

OBJECTIVES:

* Compare improvement in physiologic function, in terms of exercise tolerance, in patients with inoperable locally advanced lung cancer undergoing chemoradiotherapy and randomized to pulmonary rehabilitation comprising education with vs without supervised exercise training.

* Compare the health-related quality of life, in terms of multidimensional functioning and patient perception of respiratory difficulties, in patients undergoing these pulmonary rehabilitation interventions.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to Zubrod performance status (0-1 vs 2); FEV_1 (≥ 70% of predicted vs \< 70% of predicted); and smoking status\* (never smoked or former smoker vs current smoker). Approximately 20 weeks into treatment on SWOG-S0023, patients are randomized to 1 of 2 intervention arms.

NOTE: \* Never smoked is defined as \< 100 cigarettes in a lifetime and former smoker is defined as no smoking for ≥ 1 year.

* Arm I: Patients participate in a supervised structured exercise program (i.e., walking on a treadmill OR using a stationary exercise bicycle) 3 times a week for 12 weeks. Patients also receive educational materials on how to improve breathing and conserve energy.

* Arm II: Patients receive educational materials as in arm I. In both arms, patients undergo exercise testing using 6-minute walks to measure exercise tolerance at initial evaluation (after randomization but prior to intervention), 12 weeks, and then at 6 and 9 months.

In both arms, intervention continues in the absence of disease progression or the development of other medical conditions that would preclude study participation.

Quality of life is assessed at baseline, 12 weeks, and then at 6 and 9 months.

PROJECTED ACCRUAL: A total of 164 patients (82 per treatment arm) will be accrued for this study.

Study Timeline

• Study Start: 2004-09
• Study First Submitted: 2004-09-07
• Study First Submitted QC: 2004-09-07
• Study First Posted: 2004-09-08
• Primary Completion: 2008-10
• Study Completion: 2008-10
• Status Verified: 2012-10
• Last Update Submitted: 2012-10-31
• Last Update Posted: 2012-11-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Exercise tolerance	Baseline and at 6 months	comparison between the control and intervention arms in the percent change in the 6-minute walk distance between baseline and 6 months.

Secondary Outcome Measures

Name	Time	Method
Health-related quality of life	Baseline and at 6 months.	The difference in total score between pre-study and 6 months for the FACT-L Quality of Life measure.

Trial Locations

Locations (59)

Poudre Valley Hospital; 🇺🇸 Fort Collins, Colorado, United States

Decatur Memorial Hospital Cancer Care Institute; 🇺🇸 Decatur, Illinois, United States

Cardinal Bernardin Cancer Center at Loyola University Medical Center; 🇺🇸 Maywood, Illinois, United States

Regional Cancer Center at Memorial Medical Center; 🇺🇸 Springfield, Illinois, United States

Cancer Center of Kansas, PA - Chanute; 🇺🇸 Chanute, Kansas, United States

Cancer Center of Kansas, PA - Dodge City; 🇺🇸 Dodge City, Kansas, United States

Cancer Center of Kansas, PA - El Dorado; 🇺🇸 El Dorado, Kansas, United States

Cancer Center of Kansas-Independence; 🇺🇸 Independence, Kansas, United States

Cancer Center of Kansas, PA - Kingman; 🇺🇸 Kingman, Kansas, United States

Southwest Medical Center; 🇺🇸 Liberal, Kansas, United States

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