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
3 other identifiers
interventional
361
1 country
5
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2015
Longer than P75 for not_applicable
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 16, 2014
CompletedFirst Posted
Study publicly available on registry
September 18, 2014
CompletedStudy Start
First participant enrolled
February 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
April 22, 2019
CompletedMay 8, 2019
May 1, 2019
4.2 years
September 16, 2014
May 6, 2019
Conditions
Outcome Measures
Primary Outcomes (8)
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
Study Arms (2)
Phase I (usual care)
ACTIVE COMPARATORParticipants 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 (individualized palliative care)
EXPERIMENTALParticipants 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.
Interventions
Receive individualized palliative care
Ancillary studies
Ancillary studies
Eligibility Criteria
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- City of Hope Medical Centerlead
- National Cancer Institute (NCI)collaborator
- National Institute of Nursing Research (NINR)collaborator
Study Sites (5)
City of Hope Medical Center
Duarte, California, 91010, United States
Southern California Permanente Medical Group
Irvine, California, 92618, United States
Kaiser Permanente-Ontario Vineyard Medical Offices and Ambulatory SurgiCenter
Ontario, California, 91761, United States
Kaiser Permanente Department of Research and Evaluation
Pasadena, California, 91101, United States
Kaiser Permanente Medical Center
Riverside, California, 92505, United States
Related Publications (1)
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.
PMID: 28598227DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Betty Ferrell
City of Hope Medical Center
- PRINCIPAL INVESTIGATOR
Huong Nguyen, MD
Kaiser Permanente Department of Research and Evaluation
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 16, 2014
First Posted
September 18, 2014
Study Start
February 1, 2015
Primary Completion
April 1, 2019
Study Completion
April 22, 2019
Last Updated
May 8, 2019
Record last verified: 2019-05