Palliative Care Interventions for Outpatients Newly Diagnosed With Lung Cancer: Phase II

Study Overview
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Brief Summary
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The focus of the study is to test a nurse-led telephone-based palliative care intervention on improving the delivery of care for patients with newly diagnosed lung cancer. The study is a three site randomized control trial to determine the efficacy of the intervention on improving patients' quality of life, symptom burden, and satisfaction of care. Additionally, the study will test an innovative care delivery model to improve patients' access to palliative care. The investigators will also determine the effect of the intervention on patient activation to discuss treatment preferences with their clinician and on clinician knowledge of patients' goals of care.

Detailed Description
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Patients meeting entry criteria will be randomized to the intervention arm, palliative care plus usual care, or the usual care arm. Patients randomized to the intervention arm will receive usual oncologic care and phone calls from a nurse. Outcome measures will be collected at baseline and at the end of the patients' primary cancer treatment. The study will be performed at the Puget Sound Health Care System, Birmingham VA and Portland VA. The investigators will recruit individuals (n=138) with lung cancer over 2.5 years. The primary objective is to determine the efficacy of the nurse-led telephone-based palliative intervention on improving patients' quality of life, symptom burden, and satisfaction of care. In addition, using validated instruments, the investigators will assess the effect of the intervention on patient activation to discuss treatment preferences with their clinician and on clinician knowledge of patients' goals of care. The results of this study will inform a future effectiveness/implementation study.

Official Title
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Palliative Care Interventions for Outpatients Newly Diagnosed With Lung Cancer: Phase II

Conditions
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Lung Cancer

Intervention / Treatment
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* Behavioral: Palliative Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients diagnosed at the Puget Sound Health Care System, Birmingham VA, or Portland VA with a primary diagnosis of lung cancer that requires more than surgical resection: diagnosed within 8 weeks of recruitment must have telephone access ability to understand English able to participate in informed consent process Exclusion Criteria: Patients not eligible to participate in the study include those who are inpatients prior to randomization, those who are under the care of palliative care or hospice at the time of randomization those who have severe mental health disorders those who are unable to speak directly with the nurse over the telephone or those that have the inability to provide informed consent

Ages Eligible for Study
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Minimum Age: 40 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>This is a nurse-led telephone-based program integrating palliative care into usual oncologic care for patients diagnosed within 2 months of any type and stage of lung cancer, who will receive therapy other than solely surgical resection. The intervention lasts for the duration of patients' primary lung cancer treatment (usually 3-4 months). | Behavioral: Palliative Care<br>* Care delivered by a nurse, including symptom assessment and management, patient education on lung cancer and treatment options, discussion and communication about preferences for care, psychosocial assessment (including referrals to ancillary services), and patient-centered resources. A personalized treatment plan based on the patient's lung cancer stage, treatment, symptoms and psychosocial needs will be developed by the palliative care team (physician, study nurse) with input from the patient and family member. The study nurse will assess patient's symptoms, implement and monitor the treatment plan applying established End-of- Life Nursing Education Consortium (ELNEC) for Veterans protocols.<br>* Other names: Supportive Care;|
| No Intervention: Usual Care<br>Subjects randomized to the usual care arm will receive medical oncology, radiation oncology, pulmonary, CT surgery, as indicated by the type and stage of cancer. At the completion of their primary lung cancer treatment, they will be disenrolled from the study. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Functional Assessment of Cancer Therapy-Lung Total Outcome Index Score at Final Visit | Patient Quality of Life including symptoms as measured by the FACT-L (Functional Assessment of Cancer Therapy-Lung Scale). The FACT-L outcome measure reported is the mean change in the TOI subscale (Total Outcome Index) of the instrument, computed as the differences between final and baseline visit scores. The TOI subscale range is 0-84, with a higher score indicating a better quality of life. Among patients with newly diagnosed lung cancer, provision of a telephone-based palliative care intervention will be associated with a change in FACT-L TOI score. The investigators will assess the difference in FACT-L TOI scores between the intervention and control subjects. | Baseline and 3 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Patient Satisfaction of Care at Final Visit | Patient satisfaction with care will be assessed by using the FAMCARE-Patient Survey 13 (full unabbreviated scale name). The FAMCARE is a 13 item, 5 point likert-scale validated questionnaire measuring patient satisfaction with cancer care and assessing interactions with health care providers, performance status and symptom burden. Only total score are reported (no subscales). Scores range from 13-65 with scores of 52 > being satisfied with care. In full randomized clinical trials the estimated MID is 5 points from baseline to 12 weeks. Among patients with newly diagnosed lung cancer, provision of a telephone-based palliative care intervention will be associated with a change in FAMCARE-P13 score. The investigators will assess the difference in FAMCARE-P13 scores between the intervention and control subjects. | Baseline and 3 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Palliative Care, Supportive Care