This clinical trial studies a palliative care intervention in improving symptom control and quality of life in patients with stage II-IV non-small cell lung cancer and their family caregivers. Palliative care programs can provide patients and their caregivers with information on how to manage their symptoms, maintain health and well-being, and access supportive care services. An interdisciplinary palliative care model may effectively link lung cancer patients to the appropriate supportive care services in a timely fashion.
PRIMARY OBJECTIVES: I. Adapt a Palliative Care Intervention (PCI) tested in a National Cancer Institute (NCI) funded Program Project (P01) for dissemination to other oncology settings. II. Determine the impact of the PCI on patient outcomes including symptom control, quality of life (QOL), and distress as compared to the usual care group. III. Determine the impact of the PCI on family caregivers (FCG) outcomes including caregiver burden, caregiver distress, skills preparation and QOL as compared to the usual care group. IV. Test the effects of the PCI on patient resource utilization as compared to the usual care group. OUTLINE: Participants are enrolled sequentially to 1 of 2 phases. PHASE I: Participants receive usual care. This phase will aid in identifying usual care patterns in each site and provide an audit of system utilization as well as finalization of the educational materials for Phase II. PHASE II: Participants receive individualized palliative care comprised of tailored educational sessions designed for each patient and FCG that have been modified based on patterns observed in Phase I. The first patient teaching session will cover physical and psychological areas and the second will cover social and spiritual areas. These sessions will be completed within 2 weeks of accrual. A third teaching session is held with the FCG alone to give the FCG the opportunity to discuss their perspectives and focus on their needs. Patients will be asked to identify topics they want included and which if any should be omitted which provides for tailoring of the content to the patient's needs and preferences. In both groups, participants are followed up for 3 months.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
361
City of Hope Medical Center
Duarte, California, United States
Southern California Permanente Medical Group
Irvine, California, United States
Kaiser Permanente-Ontario Vineyard Medical Offices and Ambulatory SurgiCenter
Ontario, California, United States
Kaiser Permanente Department of Research and Evaluation
Pasadena, California, United States
Kaiser Permanente Medical Center
Riverside, California, United States
Impact of the PCI on symptom control as compared to the usual care group
The demographic and clinical characteristics as well as baseline symptom control scores in the two phases will be compared. A repeated measures mixed model will be utilized for the three repeated measures (0, 1, and 3 months).
Time frame: Up to 3 months
Impact of the PCI on patient QOL as compared to the usual care group
The demographic and clinical characteristics as well as baseline QOL scores in the two phases will be compared. A repeated measures mixed model will be utilized for the three repeated measures (0, 1, and 3 months).
Time frame: Up to 3 months
Impact of the PCI on psychological distress as compared to the usual care group
The demographic and clinical characteristics as well as baseline psychological distress scores in the two phases will be compared. A repeated measures mixed model will be utilized for the three repeated measures (0, 1, and 3 months).
Time frame: Up to 3 months
Impact of the PCI on caregiver burden as compared to the usual care group
The demographic and clinical characteristics as well as baseline caregiver burden scores in the two phases will be compared. A repeated measures mixed model will be utilized for the three repeated measures (0, 1, and 3 months).
Time frame: Up to 3 months
Impact of the PCI on caregiver distress as compared to the usual care group
The demographic and clinical characteristics as well as baseline caregiver distress scores in the two phases will be compared. A repeated measures mixed model will be utilized for the three repeated measures (0, 1, and 3 months).
Time frame: Up to 3 months
Impact of the PCI on caregiver skills preparation as compared to the usual care group
The demographic and clinical characteristics as well as baseline caregiver skills preparation scores in the two phases will be compared. A repeated measures mixed model will be utilized for the three repeated measures (0, 1, and 3 months).
Time frame: Up to 3 months
Impact of the PCI on caregiver QOL as compared to the usual care group
The demographic and clinical characteristics as well as baseline caregiver QOL scores in the two phases will be compared. A repeated measures mixed model will be utilized for the three repeated measures (0, 1, and 3 months).
Time frame: Up to 3 months
Effects of the PCI on resource utilization as compared to the usual care group
Time frame: Up to 3 months
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