This trial will compare Molecular Tumor Board (MTB) assisted care to usual care for patients who have newly diagnosed histologically or cytologically confirmed stage IIb-IV Non-Small Cell Lung Cancer (NSCLC) and are planning to undergo treatment for their cancer.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
659
Participants in this group will obtain recommendations for care from the molecular tumor board.
University of Kentucky
Lexington, Kentucky, United States
Overall survival
Overall survival 1 year survival between individuals with stage IIb-IV NSCLC who receive MTB assisted care to those who receive usual care.
Time frame: 1 year
Change in quality of life (QOL)
Quality of life will be assessed via the FACT-L (The Functional Assessment of Cancer Therapy - Lung). FACT-L has 5 areas of measurement: physical wellbeing, social/family wellbeing, emotional wellbeing, functional wellbeing, and an additional concerns list of problems specific to lung cancer. Areas are measured on a 5-point Likert-type scale of 0-4. The FACT-L subscales can be scored to yield a total score, subscale scores, as well as the Trial Outcome Index (TOI), which reflects the physical wellbeing, functional wellbeing, and lung cancer symptom subscales. TOI scores range from 0-84, with a higher score reflecting better QOL. Total FACT-G scores (physical, social, emotional, and functional wellbeing subscales) range from 0-108, with higher scores reflecting better QOL. The lung cancer subscale (i.e., additional concerns subscale) can range from 0-28 (only 7 items are scored), with higher scores reflecting better QOL.
Time frame: At enrollment, 8 weeks, and 12 weeks.
Overall survival
Comparison of overall survival between individuals with stage IIb-IV NSCLC who receive MTB assisted care to those who receive usual care
Time frame: 1 year
Change in guideline concordant care
Comparison of guideline concordant care (specifically receiving next generation sequencing (NGS) testing and treatments based on identified mutations) between individuals with stage IIb-IV NSCLC who receive MTB assisted care to those who receive usual care.
Time frame: 8 weeks, 12 weeks, and 1 year
Change in satisfaction with treatment
To compare satisfaction with treatment between individuals with stage IIb-IV NSCLC who receive MTB assisted care to those who receive usual care, including financial, psychosocial, and physical measures of satisfaction using the Functional Assessment of Chronic Illness Therapy (FACIT) - Treatment Satisfaction - General (TSG) (version 4). The FACIT-TSG is an 8-item questionnaire, with each item score ranging from 0 ("not at all") to 4 ("very much"). Total scores range from 0 to 32 with higher scores indicating greater satisfaction with treatment.
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Time frame: At enrollment, 8 weeks, and 12 weeks.