Patient Function/Fitness and Psychosocial Health in Improving Health-Related Quality of Life in Patients With Stage I-IV Non-Small Cell Lung Cancer
NCT ID: NCT02835066
Last Updated: 2018-07-27
Study Results
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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WITHDRAWN
OBSERVATIONAL
2016-07-31
2018-07-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
Integrated Fitness Assessment
Undergo function/fitness assessment
Psychosocial Assessment and Care
Undergo psychosocial health assessments
Quality-of-Life Assessment
Complete EORTC QLQ-C30 and QLQ-LC13 questionnaires
Interventions
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Integrated Fitness Assessment
Undergo function/fitness assessment
Psychosocial Assessment and Care
Undergo psychosocial health assessments
Quality-of-Life Assessment
Complete EORTC QLQ-C30 and QLQ-LC13 questionnaires
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Wake Forest University Health Sciences
OTHER
Responsible Party
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Principal Investigators
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Brian Lally
Role: PRINCIPAL_INVESTIGATOR
Wake Forest University Health Sciences
Locations
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Comprehensive Cancer Center of Wake Forest University
Winston-Salem, North Carolina, United States
Countries
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Other Identifiers
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NCI-2016-00649
Identifier Type: REGISTRY
Identifier Source: secondary_id
CCCWFU 98515
Identifier Type: OTHER
Identifier Source: secondary_id
CCCWFU 98515
Identifier Type: -
Identifier Source: org_study_id
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