Condition
Liver Cancer|Anxiety Disorder|Depression|Small Cell Lung Cancer|Extrahepatic Bile Duct Cancer|Malignant Mesothelioma|Pancreatic Cancer|Esophageal Cancer|Gastric Cancer|Non-small Cell Lung Cancer
Estimated Enrollment: 405
Age Group: 18 Years and older (Adult, Senior)
Gender: All
Study Type: Interventional
Study Design Allocation: Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: No masking|Primary Purpose: Supportive Care
Study ID Numbers: A221303|U10CA037447|UG1CA189823|NCI-2014-01943
Study First Received: January 23, 2015
Last Updated: April 19, 2017
Estimated Primary Completion Date: June 2018
Primary Outcome Measures:
Change in FACT-G scores from baseline to 12 weeks between study arms|Change in QOL on the FACT over time|Rate of depressive symptoms as per Hospital Anxiety and Depression Scale (HADS) at 12 weeks and over time|Rate of anxiety symptoms as per HADS at 12 weeks and over time|Change in illness understanding over time|Change in QOL on the SF-36 over time|Rate of referral, enrollment and length of stay on hospice|Location of death|Number of hospital and intensive care unit (ICU) admissions and days|Chemotherapy and radiation administration|Overall survival|Concordance between patient and family caregiver report of prognosis/curability
Sponsors and Collaborators:
Alliance for Clinical Trials in Oncology|National Cancer Institute (NCI)
Website Link: https://ClinicalTrials.gov/show/NCT02349412