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

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.

Study Overview

• Status: Completed
• Conditions: Stage IIIA Non-small Cell Lung Cancer; Stage IIIB Non-small Cell Lung Cancer; Caregiver; Recurrent Non-small Cell Lung Cancer; Stage IV Non-small Cell Lung Cancer; Stage IIA Non-small Cell Lung Cancer; Stage IIB Non-small Cell Lung Cancer; Psychological Impact of Cancer and Its Treatment
• Intervention / Treatment: Other: questionnaire administration; Other: quality-of-life assessment; Other: Palliative Therapy

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.

• Study Type: Interventional
• Enrollment (Actual): 361
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Duarte, California, United States, 91010
      • City of Hope Medical Center
    • Irvine, California, United States, 92618
      • Southern California Permanente Medical Group
    • Ontario, California, United States, 91761
      • Kaiser Permanente-Ontario Vineyard Medical Offices and Ambulatory SurgiCenter
    • Pasadena, California, United States, 91101
      • Kaiser Permanente Department of Research and Evaluation
    • Riverside, California, United States, 92505
      • Kaiser Permanente Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Phase I (usual care); 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.	Other: questionnaire administration; Ancillary studies; Other: quality-of-life assessment; Ancillary studies; Other Names: quality of life assessment
Experimental: Phase II (individualized palliative care); 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.	Other: questionnaire administration; Ancillary studies; Other: quality-of-life assessment; Ancillary studies; Other Names: quality of life assessment; Other: Palliative Therapy; Receive individualized palliative care; Other Names: Symptom Management; Comfort Care; Palliative Care; Palliative Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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).	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).	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).	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).	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).	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).	Up to 3 months
Effects of the PCI on resource utilization as compared to the usual care group		Up to 3 months

Collaborators and Investigators

• Sponsor: City of Hope Medical Center
• Collaborators: National Cancer Institute (NCI); National Institute of Nursing Research (NINR)
• Investigators: Principal Investigator: Betty Ferrell, City of Hope Medical Center; Principal Investigator: Huong Nguyen, MD, Kaiser Permanente Department of Research and Evaluation

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: February 1, 2015
• Primary Completion (Actual): April 1, 2019
• Study Completion (Actual): April 22, 2019

Study Registration Dates

• First Submitted: September 16, 2014
• First Submitted That Met QC Criteria: September 16, 2014
• First Posted (Estimate): September 18, 2014

Study Record Updates

• Last Update Posted (Actual): May 8, 2019
• Last Update Submitted That Met QC Criteria: May 6, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: 14206 (Other Identifier: City of Hope Medical Center); NCI-2014-01926 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); 1R01NR015341-01 (U.S. NIH Grant/Contract)