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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2016-00649 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| CCCWFU 98515 | Other Identifier | Comprehensive Cancer Center of Wake Forest University | |
| P30CA012197 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This pilot trial studies patient function/fitness and psychosocial health in improving health-related quality of life and decreasing treatment-related toxicity in patients with stage I-IV non-small cell lung cancer. Studying function/fitness and psychosocial health may help doctors improve conventional therapy in patients with non-small cell lung cancer.
PRIMARY OBJECTIVES:
I. To determine the correlation of patient-reported health-related quality of life (HRQOL) outcomes with clinical/treatment variables as well as a panel of both function/fitness and psychosocial health assessments in non-small cell lung cancer (NSCLC).
SECONDARY OBJECTIVES:
I. To investigate the panel of function/fitness and psychosocial health assessments with patient's smoking history/status as a predictor for treatment related toxicity.
TERTIARY OBJECTIVES:
I. The documentation of the NSCLC lung population from this prospective combined with others.
OUTLINE:
Patients scheduled for surgery, radiation therapy, or chemotherapy complete the European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ)-core 30 (C30) and QLQ-Lung Cancer 13 (LC13) in addition to psychosocial health and smoking status questions from baseline up to 2 weeks prior to the start of treatment, 5-6 weeks after treatment begins, and 5-6 months from the start of treatment. During the same time points, patients also undergo function/fitness assessments including standard health measurements, short physical performance battery (SPPB), 6 minute walk test (6MWT), and a grip strength test.
After completion of study treatment, patients are followed up every 3-6 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ancillary-Correlative (HRQOL, fitness and psychosocial health) | Patients scheduled for surgery, radiation therapy, or chemotherapy complete the European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ)-core 30 (C30) and QLQ-Lung Cancer 13 (LC13) in addition to psychosocial health and smoking status questions from baseline up to 2 weeks prior to the start of treatment, 5-6 weeks after treatment begins, and 5-6 months from the start of treatment. During the same time points, patients also undergo function/fitness assessments including standard health measurements, short physical performance battery (SPPB), 6 minute walk test (6MWT), and a grip strength test. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Integrated Fitness Assessment | Other | Undergo function/fitness assessment |
|
| Measure | Description | Time Frame |
|---|---|---|
| Patient function/fitness | Assessed by standard health measurements. | Up to 6 months |
| Patient well-being | Assessed by questionnaires. | Up to 6 months |
| Patient function/fitness | Assessed by performance-based measures. | Up to 6 months |
| Patient well-being | Assessed by psychosocial health questions. | Up to 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with Non-Small Cell Lung Cancer
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| Name | Affiliation | Role |
|---|---|---|
| Brian Lally | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Comprehensive Cancer Center of Wake Forest University | Winston-Salem | North Carolina | 27157 | United States |
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| Psychosocial Assessment and Care | Procedure | Undergo psychosocial health assessments |
|
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| Quality-of-Life Assessment | Procedure | Complete EORTC QLQ-C30 and QLQ-LC13 questionnaires |
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| ID | Term |
|---|---|
| D012907 | Smoking |
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D000067250 | Psychiatric Rehabilitation |
| ID | Term |
|---|---|
| D012046 | Rehabilitation |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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