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

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ClinicalTrials.gov Identifier: NCT03154190
Recruitment Status : Recruiting
First Posted : May 16, 2017
Last Update Posted : March 17, 2020
Sponsor:
Information provided by (Responsible Party):
Manali Indravadan Patel, Stanford University

Brief 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.

Condition or disease Intervention/treatment Phase
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 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 Triple-Negative Breast Carcinoma Other: Best Practice Other: Laboratory Biomarker Analysis Procedure: Supportive Care Other: Survey Administration Not Applicable

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: St. Judes-Stanford Comprehensive Support Initiative
Actual Study Start Date : December 15, 2016
Estimated Primary Completion Date : November 30, 2020
Estimated Study Completion Date : November 30, 2021


Arm Intervention/treatment
Active Comparator: Arm A (usual care)
Patients receive usual care.
Other: Best Practice
Receive usual care
Other Names:
  • standard of care
  • standard therapy

Other: Laboratory Biomarker Analysis
Correlative studies

Other: Survey Administration
Ancillary studies

Experimental: Arm B (health care coach support)
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
Correlative studies

Procedure: Supportive Care
Undergo health care coach support
Other Names:
  • Supportive Therapy
  • Symptom Management
  • Therapy, Supportive

Other: Survey Administration
Ancillary studies




Primary Outcome Measures :
  1. Emergency Department Visit (Chart Review) [ Time Frame: 6 months after patient enrollment ]
    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.

  2. Hospitalization Visits (Chart Review) [ Time Frame: 6 months after patient enrollment ]
    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.

  3. Hospice Consult (Chart Review) [ Time Frame: 6 months after patient enrollment ]
    Hospice consult for each patient will be abstracted by electronic medical record chart review for each patient at 6 months after enrollment.

  4. Palliative Care Consult (Chart Review) [ Time Frame: 6 months after patient enrollment ]
    Palliative Care consult for each patient will be abstracted by electronic medical record chart review for each patient at 6 months after enrollment.


Secondary Outcome Measures :
  1. 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 [ Time Frame: Change in patient satisfaction with care and decision making from 3 months to 6, 9, and 12 months ]
    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.

  2. Change in patient satisfaction with care among patients undergoing health care coach support as assessed by Consumer Assessment of Healthcare Providers and Systems-G. [ Time Frame: Change in patient satisfaction with care from 3 months to 6, 9, and 12 months ]
    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.

  3. Emergency Department Visit (Chart Review) [ Time Frame: 12 months after patient enrollment ]
    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.

  4. Emergency Department Visit (Chart Review) [ Time Frame: 30 days prior to death ]
    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.

  5. Hospitalization Visits (Chart Review) [ Time Frame: 12 months after patient enrollment ]
    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.

  6. Hospitalization Visits (Chart Review) [ Time Frame: 30 days prior to death ]
    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.

  7. Hospice Consult (Chart Review) [ Time Frame: 12 months after patient enrollment ]
    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.

  8. Hospice Consult (Chart Review) [ Time Frame: 30 days prior to death ]
    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.

  9. Palliative Care Consult (Chart Review) [ Time Frame: 12 months after patient enrollment ]
    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.

  10. Palliative Care Consult (Chart Review) [ Time Frame: 30 days prior to death ]
    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.

  11. Total Costs of Care [ Time Frame: Up to 12 months after patient enrollment ]
    Total costs of care for each patient will be obtained through claims data for each patient at 12 months after enrollment. We will evaluate comparisons of total costs of care for each patient between study arms.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03154190


Contacts
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Contact: Manali Patel manalip@stanford.edu

Locations
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United States, California
Virginia K Crosson Cancer Center Recruiting
Fullerton, California, United States, 29835
Contact: David J. Park       david.park@stjoe.org   
Principal Investigator: David J. Park         
Sponsors and Collaborators
Stanford University
Investigators
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Principal Investigator: Manali Patel Stanford University

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Responsible Party: Manali Indravadan Patel, Assistant Professor of Medicine, Stanford University
ClinicalTrials.gov Identifier: NCT03154190    
Other Study ID Numbers: VAR0134
First Posted: May 16, 2017    Key Record Dates
Last Update Posted: March 17, 2020
Last Verified: March 2020
Additional relevant MeSH terms:
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Carcinoma
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Melanoma
Pancreatic Neoplasms
Sarcoma
Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Stomach Neoplasms
Glioblastoma
Rectal Neoplasms
Colonic Neoplasms
Esophageal Neoplasms
Carcinoma, Renal Cell
Breast Neoplasms
Skin Neoplasms
Small Cell Lung Carcinoma
Osteosarcoma
Myelodysplastic Syndromes
Disease Progression
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Urogenital Neoplasms
Carcinoma, Bronchogenic