This randomized clinical trial studies how well stepped palliative care or early integrated palliative care works in improving quality of life in patients with lung cancer that has spread to other places in the body (advanced) or is no longer responding to treatment. Early involvement of a team of clinicians that specialize in lessening (or “palliating”) distressing physical and emotional symptoms and in helping patients and their family cope with a serious illness may improve patients’ and their loved ones’ experience with their cancer.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03337399.
PRIMARY OBJECTIVE:
I. To determine whether stepped palliative care (PC) is non-inferior to early integrated PC in improving patients’ quality of life (QOL) at 24 weeks.
SECONDARY OBJECTIVES:
I. To assess whether stepped PC is non-inferior to early integrated PC with respect to patient-clinician communication about end of life (EOL) care preferences and length of stay in hospice.
II. To compare the superiority of stepped PC versus early integrated PC with respect to resource utilization.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients meet PC clinician in person or via video at 4 weeks, at clinically relevant points in the patients' illness, within 4 weeks after a change in cancer treatment (including radiation), or within 4 weeks of discharge from an inpatient admission. Patients whose Functional Assessment of Cancer Therapy-Lung (FACT-L) scores decrease by > 10-points from baseline at any time during the study start to meet PC clinician at least every 4 weeks.
ARM II: Patients meet PC clinician in person or via video within 4 weeks of enrollment and at least every 4 weeks throughout their course of illness.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationDana-Farber Harvard Cancer Center
Principal InvestigatorJennifer Gold Temel
