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

Acute Myeloid Leukemia Clinical Trial

Official title:

St. Judes-Stanford Comprehensive Support Initiative

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03154190
• Other study ID #: VAR0134
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 8, 2017
• Est. completion date: August 30, 2022

Study information

• Verified date: January 2022
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 128
• Est. completion date: August 30, 2022
• Est. primary completion date: November 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Myeloid Leukemia
• Brain Glioblastoma
• Breast Neoplasms
• Carcinoma
• Carcinoma, Non-Small-Cell Lung
• Carcinoma, Ovarian Epithelial
• Carcinoma, Renal Cell
• Colonic Neoplasms
• Disease Progression
• Esophageal Neoplasms
• Estrogen Receptor Negative
• Extensive Stage Small Cell Lung Carcinoma
• Glioblastoma
• Head and Neck Carcinoma
• HER2/Neu Negative
• Hormone-Resistant Prostate Cancer
• Limited Stage Small Cell Lung Carcinoma
• Lung Neoplasms
• Melanoma
• Myelodysplastic Syndrome
• Myelodysplastic Syndromes
• Osteosarcoma
• Ovarian Neoplasms
• Pancreatic Neoplasms
• Progesterone Receptor Negative
• Progressive Disease
• Rectal Neoplasms
• Recurrent Carcinoma
• Sarcoma
• Skin Neoplasms
• Small Cell Lung Carcinoma
• Stage II Pancreatic Cancer
• Stage II Rectal Cancer
• Stage IIA Pancreatic 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 Colon 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
• Stomach Neoplasms
• Triple-Negative Breast Carcinoma

Intervention

Other:
• Best Practice
Receive usual care
• Laboratory Biomarker Analysis
Correlative studies

Procedure:
• Supportive Care
Undergo health care coach support

Other:
• Survey Administration
Ancillary studies

Locations

Country	Name	City	State
United States	Virginia K Crosson Cancer Center	Fullerton	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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