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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Translation of a Lung Cancer Palliative Care Intervention for Clinical Practice

Conditions
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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

Intervention / Treatment
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* Other: Palliative Therapy
* Other: quality-of-life assessment
* Other: questionnaire administration


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Phase I (usual care)<br>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: quality-of-life assessment<br>* Ancillary studies<br>* Other names: quality of life assessment;Other: questionnaire administration<br>* Ancillary studies<br>|
| Experimental: Phase II (individualized palliative care)<br>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: Palliative Therapy<br>* Receive individualized palliative care<br>* Other names: Symptom Management;Other: quality-of-life assessment<br>* Ancillary studies<br>* Other names: quality of life assessment;Other: questionnaire administration<br>* Ancillary studies<br>|

What is the study measuring?
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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 |