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

Stanford University

Status: Active, not recruiting

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

Treatments: Procedure: Supportive Care; Other: Laboratory Biomarker Analysis; Other: Best Practice; Other: Survey Administration

Study type: Interventional

Funder types: Other

Identifiers

NCT03154190

VAR0134

Details and patient eligibility

About

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.

Full 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.

Enrollment: 128 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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128 participants in 2 patient groups

Arm A (usual care)

Active Comparator group

Description:

Patients receive usual care.

Treatment:

Other: Survey Administration

Other: Best Practice

Other: Laboratory Biomarker Analysis

Arm B (health care coach support)

Experimental group

Description:

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.

Treatment:

Other: Survey Administration

Other: Laboratory Biomarker Analysis

Procedure: Supportive Care