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

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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

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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