NCT02243748

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

Translation of a Lung Cancer Palliative Care Intervention for Clinical Practice

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 361 (actual)
• Sponsor: City of Hope Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Caregiver
• Psychological Impact of Cancer and Its Treatment
• Recurrent Non-small Cell Lung Cancer
• Stage IIA Non-small Cell Lung Cancer
• Stage IIB Non-small Cell Lung Cancer
• Stage IIIA Non-small Cell Lung Cancer
• Stage IIIB Non-small Cell Lung Cancer
• Stage IV Non-small Cell Lung Cancer

Interventions

Type	Name	Description
OTHER	Palliative Therapy	Receive individualized palliative care
OTHER	quality-of-life assessment	Ancillary studies
OTHER	questionnaire administration	Ancillary studies

Timeline

• Start date: 2015-02-01
• Primary completion: 2019-04-01
• Completion: 2019-04-22
• First posted: 2014-09-18
• Last updated: 2019-05-08

Locations

5 sites across 1 country: United States