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Early Palliative Care With Standard Care or Standard Care Alone in Improving Quality of Life of Patients With Incurable Lung or Non-colorectal Gastrointestinal Cancer and Their Family Caregivers

By April 24, 2017 No Comments

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

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