Health Care Coach Support in Reducing Acute Care Use and Cost in Patients With Cancer

Study Overview
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Brief Summary
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This randomized pilot clinical trial studies health care coach support in reducing acute care use and cost in patients with cancer. Health care coach support may help cancer patients to make decisions about their care that matches what is important to them with symptom management.

Detailed Description
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PRIMARY OBJECTIVES: I. To reduce acute care utilization by 2-5% for advanced cancer patients by training and deploying health care coaches who help patients and families discuss care goals, virtual modalities, engage in shared-decision-making, and participate in educational activities. SECONDARY OBJECTIVES: I. To improve patients' experience of their care. II. Improve patient understanding of advanced care planning. III. To improve the receipt of goal concordant care. IV. To reduce total healthcare costs. OUTLINE: Patients are randomized to 1 of 2 arms. ARM A: Patients receive usual care. ARM B: Patients undergo health care coach support with a baseline introduction (either telephonic or in-person) of the program followed by a visit (telephonic or in-person) with the health care coach after the first oncology appointment to discuss goals of care. The health care coach will contact patient based on patients' ongoing needs (weekly to monthly) and will conduct symptom assessments based on patients' treatment plans and symptoms. After completion of study, patients are followed up for 6 months.

Official Title
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St. Judes-Stanford Comprehensive Support Initiative

Conditions
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Stage IIA Pancreatic Cancer, Stage IV Colon Cancer, Acute Myeloid Leukemia, Brain Glioblastoma, Estrogen Receptor Negative, Extensive Stage Small Cell Lung Carcinoma, Head and Neck Carcinoma, HER2/Neu Negative, Hormone-Resistant Prostate Cancer, Limited Stage Small Cell Lung Carcinoma, Myelodysplastic Syndrome, Progesterone Receptor Negative, Progressive Disease, Recurrent Carcinoma, Stage II Pancreatic Cancer, Stage II Rectal Cancer, Stage IIA Rectal Cancer, Stage IIB Pancreatic Cancer, Stage IIB Rectal Cancer, Stage IIC Rectal Cancer, Stage III Colon Cancer, Stage III Esophageal Cancer, Stage III Gastric Cancer, Stage III Non-Small Cell Lung Cancer, Stage III Ovarian Cancer, Stage III Pancreatic Cancer, Stage III Rectal Cancer, Stage III Skin Melanoma, Stage IIIA Colon Cancer, Stage IIIA Esophageal Cancer, Stage IIIA Gastric Cancer, Stage IIIA Non-Small Cell Lung Cancer, Stage IIIA Ovarian Cancer, Stage IIIA Rectal Cancer, Stage IIIA Skin Melanoma, Stage IIIB Colon Cancer, Stage IIIB Esophageal Cancer, Stage IIIB Gastric Cancer, Stage IIIB Non-Small Cell Lung Cancer, Stage IIIB Ovarian Cancer, Stage IIIB Rectal Cancer, Stage IIIB Skin Melanoma, Stage IIIC Colon Cancer, Stage IIIC Esophageal Cancer, Stage IIIC Gastric Cancer, Stage IIIC Ovarian Cancer, Stage IIIC Rectal Cancer, Stage IIIC Skin Melanoma, Stage IV Bladder Cancer, Stage IV Bone Sarcoma, Stage IV Breast Cancer, Stage IV Esophageal Cancer, Stage IV Gastric Cancer, Stage IV Non-Small Cell Lung Cancer, Stage IV Ovarian Cancer, Stage IV Pancreatic Cancer, Stage IV Rectal Cancer, Stage IV Renal Cell Cancer, Stage IV Skin Melanoma, Stage IV Soft Tissue Sarcoma, Stage IVA Bone Sarcoma, Stage IVA Colon Cancer, Stage IVA Rectal Cancer, Stage IVB Bone Sarcoma, Stage IVB Colon Cancer, Stage IVB Rectal Cancer, Triple-Negative Breast Carcinoma

Intervention / Treatment
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* Other: Best Practice
* Other: Laboratory Biomarker Analysis
* Procedure: Supportive Care
* Other: Survey Administration


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Newly diagnosed patients for the following conditions Colon cancer stage III and IV Rectal cancer stage II, III, IV Glioblastoma multiforme (brain) -- no stage Non-small cell lung cancer stage IIIA, IIIB, IV Small cell lung cancer, limited stage and extensive stage Castration-resistant prostate cancer Head and neck cancer stage III and IV Gastric cancer stage III and IV Esophageal cancer stage III and IV Pancreatic cancer stage II, III, IV Renal cell carcinoma, stage IV Breast cancer, stage IV, if triple negative ER/PR/H2N negative or on systemic chemotherapy Sarcoma, stage IV Bladder carcinoma, stage IV Acute myeloid leukemia Melanoma, stage III and IV Ovarian cancer, stage III and IV High grade myelodysplastic syndrome (MDS) Any patient with recurrent or progressive cancer Patients must have the ability to understand and willingness to sign a written informed consent document Patient must have ongoing oncologic needs and plan to receive all care at the study institution and not already be in hospice or home-care Exclusion Criteria: Patients must have capacity to consent Pregnant patients are excluded

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: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arm A (usual care)<br>Patients receive usual care. | Other: Best Practice<br>* Receive usual care<br>* Other names: standard therapy;Other: Laboratory Biomarker Analysis<br>* Correlative studies<br>Other: Survey Administration<br>* Ancillary studies<br>|
| Experimental: Arm B (health care coach support)<br>Patients undergo health care coach support with a baseline introduction (either telephonic or in-person) of the program followed by a visit (telephonic or in-person) with the health care coach after the first oncology appointment to discuss goals of care. The health care coach will contact patient based on patients' ongoing needs (weekly to monthly) and will conduct symptom assessments based on patients' treatment plans and symptoms. | Other: Laboratory Biomarker Analysis<br>* Correlative studies<br>Procedure: Supportive Care<br>* Undergo health care coach support<br>* Other names: Therapy, Supportive;Other: Survey Administration<br>* Ancillary studies<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Emergency Department Visit (Chart Review) | Emergency Department use for each patient will be abstracted by electronic medical record chart review for each patient at 6 months after enrollment. We will evaluate comparisons of emergency department visits between study arms. | 6 months after patient enrollment | 
| Hospitalization Visits (Chart Review) | Hospitalization use for each patient will be abstracted by electronic medical record chart review for each patient at 6 months after enrollment. We will evaluate comparisons of hospitalizations between the two study arms. | 6 months after patient enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in patient satisfaction with care and decision making among patients undergoing health care coach support as assessed by Consumer Assessment of Healthcare Providers and Systems-G and Patient Satisfaction with Decision Scale | Each patient will receive a satisfaction with decision-making survey (The Satisfaction with Decision Survey) at 3 months, 6 months, 9 months, and 12 months. | Change in patient satisfaction with care and decision making from 3 months to 6, 9, and 12 months | 
| Change in patient satisfaction with care among patients undergoing health care coach support as assessed by Consumer Assessment of Healthcare Providers and Systems-G. | Each patient will receive a satisfaction with care survey (The Consumer Assessment of Healthcare Providers and Systems-G) at 3 months, 6 months, 9 months, and 12 months. | Change in patient satisfaction with care from 3 months to 6, 9, and 12 months | 
| Emergency Department Visit (Chart Review) | Emergency Department use for each patient will be abstracted by electronic medical record chart review for each patient at 12 months after enrollment. We will evaluate comparisons of emergency department visits between study arms. | 12 months after patient enrollment | 
| Emergency Department Visit (Chart Review) | Emergency Department use for each patient will be abstracted by electronic medical record chart review for each patient who has died. We will evaluate comparisons of emergency department visits between study arms. | 30 days prior to death | 
| Hospitalization Visits (Chart Review) | Hospital use for each patient will be abstracted by electronic medical record chart review for each patient at 12 months after enrollment. We will evaluate comparisons of hospitalization use between study arms. | 12 months after patient enrollment | 
| Hospitalization Visits (Chart Review) | Hospital use for each patient will be abstracted by electronic medical record chart review for each patient who has died. We will evaluate comparisons of hospitalization use between study arms. | 30 days prior to death | 
| Hospice Consult (Chart Review) | Hospice use for each patient will be abstracted by electronic medical record chart review for each patient at 12 months after enrollment. We will evaluate comparisons of hospice use between study arms. | 6 months after patient enrollment | 
| Hospice Consult (Chart Review) | Hospice use for each patient will be abstracted by electronic medical record chart review for each patient at 12 months after enrollment. We will evaluate comparisons of hospice use between study arms. | 12 months after patient enrollment | 
| Hospice Consult (Chart Review) | Hospice use for each patient will be abstracted by electronic medical record chart review for each patient who has died. We will evaluate comparisons of hospice use between study arms. | 30 days prior to death | 
| Palliative Care Consult (Chart Review) | Palliative Care consult for each patient will be abstracted by electronic medical record chart review for each patient at 12 months after enrollment. We will evaluate comparisons of palliative care use between study arms. | 6 months after patient enrollment | 
| Palliative Care Consult (Chart Review) | Palliative Care consult for each patient will be abstracted by electronic medical record chart review for each patient at 12 months after enrollment. We will evaluate comparisons of palliative care use between study arms. | 12 months after patient enrollment | 
| Palliative Care Consult (Chart Review) | Palliative Care consult for each patient will be abstracted by electronic medical record chart review for each patient who has died. We will evaluate comparisons of palliative care use between study arms. | 30 days prior to death |