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

NCT00090961 | Terminated

• 3 other identifiers: CDR0000380928U10CA012027SWOG-S0229
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 60

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.

Conditions

Lung Cancer; Pulmonary Complications

Keywords

pulmonary complications; stage IIIA non-small cell lung cancer; stage IIIB non-small cell lung cancer; squamous cell lung cancer; large cell lung cancer; adenocarcinoma of the lung; bronchoalveolar cell lung cancer; limited stage small cell lung cancer

Outcome Measures

Primary Outcomes (1)

• Exercise tolerance

  comparison between the control and intervention arms in the percent change in the 6-minute walk distance between baseline and 6 months.

  Baseline and at 6 months

Secondary Outcomes (1)

• Health-related quality of life

  Baseline and at 6 months.

Study Arms (2)

12-week exercise program + education

EXPERIMENTAL

A 12-week supervised exercise program consisting of 3 days a week on a stationary bike or treadmill. In addition, at the time of enrollment patients are provided educational materials focusing on breathing and energy conservation.

Other: educational intervention; Other: supervised exercise program

Education

OTHER

At the time of enrollment patients are provided educational materials focusing on breathing and energy conservation.

Other: educational intervention

Interventions

educational intervention OTHER

12-week exercise program + education; Education

supervised exercise program OTHER

12-week exercise program + education

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed single, primary bronchogenic lung cancer * Inoperable, locally advanced disease (unresectable stage IIIA OR stage IIIB disease) * The following histologies are eligible: * Adenocarcinoma * Large cell carcinoma * Squamous cell carcinoma * Non-lobar and non-diffuse bronchoalveolar carcinoma * Small cell lung cancer * Must have received chemotherapy (platinum based) and radiotherapy for locally advanced unresectable lung cancer * Must have achieved a complete response, partial response, or stable disease after treatment PATIENT CHARACTERISTICS: Age * Not specified Performance status * Zubrod 0-2 Life expectancy * Not specified Hematopoietic * Not specified Hepatic * Not specified Renal * Not specified Cardiovascular * No acute EKG changes, arrhythmia, or other cardiac abnormality that would preclude study participation * No uncontrolled cardiac disease * No recent myocardial infarction Pulmonary * Any FEV\_1 level by pulmonary function testing Other * Willing to participate in 12-week long exercise program * Chemotherapy-induced neuropathy ≤ grade 2 * No uncontrolled diabetes mellitus * No other medical condition that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * See Disease Characteristics Endocrine therapy * Not specified Radiotherapy * See Disease Characteristics Surgery * Not specified

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• SWOG Cancer Research Network: lead
• National Cancer Institute (NCI): collaborator

Study Sites (60)

Poudre Valley Hospital

Fort Collins, Colorado, 80524, United States

Location

Decatur Memorial Hospital Cancer Care Institute

Decatur, Illinois, 62526, United States

Location

Cardinal Bernardin Cancer Center at Loyola University Medical Center

Maywood, Illinois, 60153, United States

Location

Regional Cancer Center at Memorial Medical Center

Springfield, Illinois, 62781-0001, United States

Location

Cancer Center of Kansas, PA - Chanute

Chanute, Kansas, 66720, United States

Location

Cancer Center of Kansas, PA - Dodge City

Dodge City, Kansas, 67801, United States

Location

Cancer Center of Kansas, PA - El Dorado

El Dorado, Kansas, 67042, United States

Location

Cancer Center of Kansas-Independence

Independence, Kansas, 67301, United States

Location

Cancer Center of Kansas, PA - Kingman

Kingman, Kansas, 67068, United States

Location

Southwest Medical Center

Liberal, Kansas, 67901, United States

Location

Cancer Center of Kansas, PA - Newton

Newton, Kansas, 67114, United States

Location

Cancer Center of Kansas, PA - Parsons

Parsons, Kansas, 67357, United States

Location

Cancer Center of Kansas, PA - Pratt

Pratt, Kansas, 67124, United States

Location

Cancer Center of Kansas, PA - Salina

Salina, Kansas, 67042, United States

Location

Tammy Walker Cancer Center at Salina Regional Health Center

Salina, Kansas, 67401, United States

Location

Cancer Center of Kansas, PA - Wellington

Wellington, Kansas, 67152, United States

Location

Associates in Womens Health, PA - North Review

Wichita, Kansas, 67208, United States

Location

Cancer Center of Kansas, PA - Medical Arts Tower

Wichita, Kansas, 67208, United States

Location

Cancer Center of Kansas, PA - Wichita

Wichita, Kansas, 67214, United States

Location

CCOP - Wichita

Wichita, Kansas, 67214, United States

Location

Via Christi Cancer Center at Via Christi Regional Medical Center

Wichita, Kansas, 67214, United States

Location

Cancer Center of Kansas, PA - Winfield

Winfield, Kansas, 67156, United States

Location

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, 48201-1379, United States

Location

Regional Cancer Center at Singing River Hospital

Pascagoula, Mississippi, 39581, United States

Location

CCOP - Cancer Research for the Ozarks

Springfield, Missouri, 65802, United States

Location

St. John's Regional Health Center

Springfield, Missouri, 65804, United States

Location

Hulston Cancer Center at Cox Medical Center South

Springfield, Missouri, 65807, United States

Location

CCOP - Montana Cancer Consortium

Billings, Montana, 59101, United States

Location

Hematology-Oncology Centers of the Northern Rockies - Billings

Billings, Montana, 59101, United States

Location

Northern Rockies Radiation Oncology Center

Billings, Montana, 59101, United States

Location

St. Vincent Healthcare Cancer Care Services

Billings, Montana, 59101, United States

Location

Billings Clinic - Downtown

Billings, Montana, 59107-7000, United States

Location

Bozeman Deaconess Cancer Center

Bozeman, Montana, 59715, United States

Location

St. James Healthcare Cancer Care

Butte, Montana, 59701, United States

Location

Big Sky Oncology

Great Falls, Montana, 59405-5309, United States

Location

Great Falls Clinic - Main Facility

Great Falls, Montana, 59405, United States

Location

Sletten Cancer Institute at Benefis Healthcare

Great Falls, Montana, 59405, United States

Location

Unknown Facility

Great Falls, Montana, 59405, United States

Location

Northern Montana Hospital

Havre, Montana, 59501, United States

Location

St. Peter's Hospital

Helena, Montana, 59601, United States

Location

Glacier Oncology, PLLC

Kalispell, Montana, 59901, United States

Location

Kalispell Medical Oncology at KRMC

Kalispell, Montana, 59901, United States

Location

Kalispell Regional Medical Center

Kalispell, Montana, 59901, United States

Location

Community Medical Center

Missoula, Montana, 59801, United States

Location

Guardian Oncology and Center for Wellness

Missoula, Montana, 59804, United States

Location

Montana Cancer Specialists at Montana Cancer Center

Missoula, Montana, 59807-7877, United States

Location

Montana Cancer Center at St. Patrick Hospital and Health Sciences Center

Missoula, Montana, 59807, United States

Location

Wayne Memorial Hospital, Incorporated

Goldsboro, North Carolina, 27534, United States

Location

St. Joseph Cancer Center

Bellingham, Washington, 98225, United States

Location

Olympic Hematology and Oncology

Bremerton, Washington, 98310, United States

Location

Columbia Basin Hematology

Kennewick, Washington, 99336, United States

Location

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98104, United States

Location

Harborview Medical Center

Seattle, Washington, 98104, United States

Location

Minor and James Medical, PLLC

Seattle, Washington, 98104, United States

Location

Group Health Central Hospital

Seattle, Washington, 98112, United States

Location

Swedish Cancer Institute at Swedish Medical Center - First Hill Campus

Seattle, Washington, 98122-4307, United States

Location

Polyclinic First Hill

Seattle, Washington, 98122, United States

Location

University Cancer Center at University of Washington Medical Center

Seattle, Washington, 98195-6043, United States

Location

Cancer Care Northwest - Spokane South

Spokane, Washington, 99202, United States

Location

Welch Cancer Center at Sheridan Memorial Hospital

Sheridan, Wyoming, 82801, United States

Location

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Adenocarcinoma of Lung; Adenocarcinoma, Bronchiolo-Alveolar

Interventions

Early Intervention, Educational

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Child Health Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Preventive Health Services

Study Officials

• Antoinette J. Wozniak, MD

  Barbara Ann Karmanos Cancer Institute

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2004
• First Posted: September 8, 2004
• Study Start: September 1, 2004
• Primary Completion: October 1, 2008
• Study Completion: October 1, 2008
• Last Updated: November 1, 2012

Record last verified: 2012-10

Locations

US (60)