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

Not Applicable

Completed

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

• Registration Number: NCT02243748
• Lead Sponsor: City of Hope Medical Center

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.

Study Timeline

• Study First Submitted: 2014-09-16
• Study First Submitted QC: 2014-09-16
• Study First Posted: 2014-09-18
• Study Start: 2015-02
• Primary Completion: 2019-04
• Study Completion: 2019-04-22
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-06
• Last Update Posted: 2019-05-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 361

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Phase II (individualized palliative care)	quality-of-life assessment	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.
Phase I (usual care)	quality-of-life assessment	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 (individualized palliative care)	questionnaire administration	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.
Phase I (usual care)	questionnaire administration	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 (individualized palliative care)	Palliative Therapy	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.

Primary Outcome Measures

Name	Time	Method
Impact of the PCI on symptom control as compared to the usual care group	Up to 3 months	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).
Impact of the PCI on caregiver burden as compared to the usual care group	Up to 3 months	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).
Impact of the PCI on caregiver distress as compared to the usual care group	Up to 3 months	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).
Impact of the PCI on psychological distress as compared to the usual care group	Up to 3 months	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).
Impact of the PCI on patient QOL as compared to the usual care group	Up to 3 months	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).
Impact of the PCI on caregiver skills preparation as compared to the usual care group	Up to 3 months	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).
Impact of the PCI on caregiver QOL as compared to the usual care group	Up to 3 months	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).
Effects of the PCI on resource utilization as compared to the usual care group	Up to 3 months

Trial Locations

Locations (5)

City of Hope Medical Center; 🇺🇸 Duarte, 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

Southern California Permanente Medical Group; 🇺🇸 Irvine, California, United States

Kaiser Permanente Medical Center; 🇺🇸 Riverside, California, United States