Clinical trial 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
Official title: Translation of a Lung Cancer Palliative Care Intervention for Clinical Practice
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: City of Hope Medical Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: National Institute of Nursing Research (NINR)
First posted: 2014-09-18
Enrollment: 361
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Eligibility criteria: Inclusion Criteria:

Patient eligibility criteria for entry into the project include:

* Diagnosis of stages II-IV non-small cell lung cancer (NSCLC)
* Undergoing treatment with surgery, chemotherapy, radiation, or combined modalities
* In Phase 2, subjects are also required on accrual to be referred to Palliative Care

FCG eligibility criteria include:

* Designated by the patient as a person closely involved in their care
* Age 18 years and older

All subjects must have the ability to understand and the willingness to sign a written informed consent

Primary outcomes:
measure: Impact of the PCI on symptom control as compared to the usual care group
timeFrame: Up to 3 months
measure: Impact of the PCI on patient QOL as compared to the usual care group
timeFrame: Up to 3 months
measure: Impact of the PCI on psychological distress as compared to the usual care group
timeFrame: Up to 3 months
measure: Impact of the PCI on caregiver burden as compared to the usual care group
timeFrame: Up to 3 months
measure: Impact of the PCI on caregiver distress as compared to the usual care group
timeFrame: Up to 3 months
measure: Impact of the PCI on caregiver skills preparation as compared to the usual care group
timeFrame: Up to 3 months
measure: Impact of the PCI on caregiver QOL as compared to the usual care group
timeFrame: Up to 3 months
measure: Effects of the PCI on resource utilization as compared to the usual care group
timeFrame: Up to 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope Medical Center
state: California
city: Irvine
country: United States
facility: Southern California Permanente Medical Group
state: California
city: Ontario
country: United States
facility: Kaiser Permanente-Ontario Vineyard Medical Offices and Ambulatory SurgiCenter
state: California
city: Pasadena
country: United States
facility: Kaiser Permanente Department of Research and Evaluation
state: California
city: Riverside
country: United States
facility: Kaiser Permanente Medical Center
state: California
Study officials:
affiliation: City of Hope Medical Center
name: Betty Ferrell
role: PRINCIPAL_INVESTIGATOR
affiliation: Kaiser Permanente Department of Research and Evaluation
name: Huong Nguyen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nguyen HQ, Cuyegkeng T, Phung TO, Jahn K, Borneman T, Macias M, Ruel N, Ferrell BR. Integration of a Palliative Care Intervention into Community Practice for Lung Cancer: A Study Protocol and Lessons Learned with Implementation. J Palliat Med. 2017 Dec;20(12):1327-1337. doi: 10.1089/jpm.2017.0143. Epub 2017 Jun 9.