Early Palliative Care in Advanced Lung and Gastrointestinal Malignancies

Study Overview
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Brief Summary
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The purpose of this study is to compare two types of care - standard oncology care and standard oncology care with early palliative care (started soon after diagnosis) to see which is better for improving the experience of patients and families with advanced lung and non-colorectal GI cancer. The study will use questionnaires to measure patients' and caregivers' quality of life, mood, coping and understanding of their illness.

Detailed Description
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Subjects and their caregiver will complete a baseline questionnaire and then be randomized to a study group. Subjects who are randomized to Standard Oncology Care will follow up with their treating oncologist. They will consult with the palliative care team at their request or at the request of the treating oncologist. They will complete questionnaires at 12 weeks and 24 weeks after enrollment. Subjects who are randomized to the Standard Oncology Care with Early Palliative Care will meet with a palliative care clinician at their next medical oncology visit or infusion visit. They will meet with the palliative care clinician at least every three weeks. They will complete questionnaires at 12 and 24 weeks after enrollment.

Official Title
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Randomized Study of Early Palliative Care Integrated With Standard Oncology Care Versus Standard Oncology Care Alone in Patients With Advanced Lung and Non-colorectal Gastrointestinal Malignancies

Conditions
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Non-small Cell Lung Cancer, Small Cell Lung Cancer, Mesothelioma, Esophageal Cancer, Gastric Cancer, Liver Cancer, Pancreatic Cancer

Intervention / Treatment
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* Other: early palliative care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Confirmed metastatic lung cancer (NSCLC, small cell lung cancer, and mesothelioma)or non-colorectal GI cancer (esophageal, gastric and hepatobiliary) not being treated with curative intent Informed of metastatic disease within the previous 8 weeks No prior therapy for metastatic disease Able to read questions in English or willing to complete questionnaires with the assistance of an interpreter Relative or friend of patient who will likely accompany the patient to clinic visits Exclusion Criteria: Significant psychiatric or other co-morbid disease

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: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: early palliative care
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Early Palliative Care<br>Subjects receive standard of care with early palliative care. | Other: early palliative care<br>* patient assigned to the intervention will receive early palliative care along with standard oncology care.<br>|
| No Intervention: Standard of Care<br>Subjects receives standard of care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional Assessment of Cancer Therapy (Quality of Life Measure) | The Functional Assessment of Cancer Therapy - General is a quality of life measure with higher scores indicating better quality of life (range 0-108). We are examining the adjusted mean difference from baseline to 12 weeks in this study | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional Assessment of Cancer Therapy (Quality of Life Measure) | The Functional Assessment of Cancer Therapy - General is a quality of life measure with higher scores indicating better quality of life (range 0-108). We are examining the adjusted mean difference from baseline to 24 weeks. | 24 weeks | 
| Rate of Clinically Significant Depression Symptoms Based on Hospital Anxiety and Depression Scale | The hospital anxiety and depression scale examines symptoms of depression and anxiety. We compared rates of clinically significant depression symptoms (using a cut off of 8 on the depression subscale score) between study arms at week-12 and week-24. | Week-12 and Week-24 | 
| Number and Percentage of Participants Who Reported Goal of Their Cancer Treatment is to Cure Their Cancer | We used the response to an item on Perception of Treatment and Prognosis Questionnaire to compare rates of accurate prognostic understanding between study arms. Participants reported their primary goal of their current cancer treatment: 1) to cure my cancer; 2) to lesson my suffering as much as possible; 3) for me and/or my family to be able to keep hoping; 4) to make sure I have done everything; 5) to extend my life as long as possible; 6) to help cancer research. Participants' responses were dichotomized as 1) to cure my cancer vs. all other. | Week12 and Week 24 | 
| Family Caregiver Quality of Life as Measured by the SF-36 | The Medical Health Outcomes Survey- Short Form (SF-36) is a measure of QOL. The SF-36 measures eight domains of health-related quality of life: physical functioning, role limitation due to physical health, bodily pain, general health perceptions, vitality, social functioning, role limitation due to emotional health, and mental health. The response choices are scored and summed to yield two physical (PCS) and mental (MCS) component summary measures with ranges from 0-100. Higher scores indicate better quality of life. We compared family caregiver PCS and MCS scores between the two study arms at week-12 and week-24 adjusting for baseline scores. | Week-12 and Week-24 | 
| Family Caregiver Psychological Distress (Based on the Hospital Anxiety and Depression Scale) | We used the Hospital Anxiety and Depression scale to measure overall psychological distress in family caregivers. The Hospital Anxiety and Depression Scale contains two subscales measuring depression and anxiety respectively. When examined continuously, this scale reflects degree of psychological distress with higher scores indicating more psychological distress (range 0-42). We compared overall psychological distress (HADS-total) among family caregivers between the two study arms | Week 12 and Week 24 | 
| Number and Percentage of Family Caregivers Who Reported the Goal of Treatment is to Cure Cancer | We used the response to an item on Perception of Treatment and Prognosis Questionnaire to compare rates of accurate prognostic understanding between study arms. Family caregivers reported their primary goal of the current cancer treatment: 1) to cure my cancer; 2) to lesson my suffering as much as possible; 3) for me and/or my family to be able to keep hoping; 4) to make sure I have done everything; 5) to extend my life as long as possible; 6) to help cancer research. Family caregivers' responses were dichotomized as 1) to cure my cancer vs. all other. | 12 and 24 weeks | 
| Coping (Brief Cope) | compare mean change in approach oriented coping from baseline to week-24. Approach oriented coping scale is composed of active coping, positive reframing, and acceptance subscales. Scores range from 0-8 with higher scores indicate higher approach-oriented coping | Up to week-24 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Palliative care, Lung, Gastric, Liver, Pancreatic, Esophageal, Caregiver