This randomized phase III trial studies how well early palliative care integrated with standard care works compared with standard care alone in improving the quality of life of patients with lung or non-colorectal gastrointestinal cancer that cannot be cured and their family caregivers. Palliative care focuses on improving the quality of life for patients with advanced diseases and their family members by providing support for relief of physical symptoms, emotional and psychological support, and counseling. Patients who receive palliative care along with their regular care at an earlier time in their disease may experience fewer emotional and physical issues from their cancer. This may also improve the quality of life of family caregivers.
Additional locations may be listed on ClinicalTrials.gov for NCT02349412.
See trial information on ClinicalTrials.gov for a list of participating sites.
PRIMARY OBJECTIVES:
I. To determine the efficacy of early integrated palliative care (PC) on patient reported quality-of-life (QOL) at 12 weeks using the Functional Assessment of Cancer Therapy (FACT) in patients with newly diagnosed incurable lung or non-colorectal gastrointestinal cancer.
SECONDARY OBJECTIVES:
I. To determine the efficacy of early integrated palliative care (PC) on other patient reported outcomes in patients with newly diagnosed incurable lung or non-colorectal gastrointestinal cancer, by assessing the endpoints detailed.
II. To determine the efficacy of early integrated palliative care (PC) on family caregiver reported outcomes in those with newly diagnosed incurable lung or non-colorectal gastrointestinal cancer, by assessing the endpoints detailed.
III. To assess the impact of early, integrated PC on quality of end-of-life (EOL) care and resource utilization in patients with newly diagnosed incurable lung or non-colorectal gastrointestinal cancer by assessing the endpoints detailed.
IV. To determine concordance between patient and family caregiver report of prognosis/curability.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I (EARLY PALLIATIVE CARE): Patients receive standard oncology care and early integrated palliative care comprising clinic visits (or phone calls if visits are not feasible) at baseline and as needed or at least every 4 weeks throughout the patient’s life.
ARM II (STANDARD ONCOLOGY CARE): Patients receive standard oncology care.
After completion of study, patients are followed up every 4 months from week 24 to up to 3 years.
Trial PhasePhase III
Trial Typesupportive care
Lead OrganizationAlliance for Clinical Trials in Oncology
Principal InvestigatorJennifer Gold Temel
