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

Stage IV Non-small Cell Lung Cancer Clinical Trial

Official title:

Translation of a Lung Cancer Palliative Care Intervention for Clinical Practice

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02243748
• Other study ID #: 14206
• Secondary ID: NCI-2014-0192614
• Status: Completed
• Phase: N/A
• Start date: February 2015
• Est. completion date: April 22, 2019

Study information

• Verified date: May 2019
• Source: City of Hope Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 361
• Est. completion date: April 22, 2019
• Est. primary completion date: April 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Caregiver
• Lung Neoplasms
• 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

Intervention

Other:
• Palliative Therapy
Receive individualized palliative care
• quality-of-life assessment
Ancillary studies
• questionnaire administration
Ancillary studies

Locations

Country	Name	City	State
United States	City of Hope Medical Center	Duarte	California
United States	Southern California Permanente Medical Group	Irvine	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	Kaiser Permanente Medical Center	Riverside	California

Sponsors (3)

Lead Sponsor	Collaborator
City of Hope Medical Center	National Cancer Institute (NCI), National Institute of Nursing Research (NINR)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Effects of the PCI on resource utilization as compared to the usual care group		Up to 3 months