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

Not Applicable

• Conditions: Progesterone Receptor Negative; Progressive Disease; Stage IIA Rectal Cancer; Stage IIB Rectal Cancer; Stage III Non-Small Cell Lung Cancer; Head and Neck Carcinoma; Limited Stage Small Cell Lung Carcinoma; Myelodysplastic Syndrome; Stage II Pancreatic Cancer; Stage IIA Pancreatic Cancer
• Interventions: Other: Best Practice; Other: Laboratory Biomarker Analysis; Procedure: Supportive Care; Other: Survey Administration

• Registration Number: NCT03154190
• Lead Sponsor: 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.

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.

Study Timeline

• Study First Submitted: 2016-11-14
• Study First Submitted QC: 2017-05-12
• Study First Posted: 2017-05-16
• Study Start: 2017-08-08
• Primary Completion: 2021-11-30
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-31
• Last Update Posted: 2022-02-03
• Study Completion: 2022-08-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 128

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

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Exclusion Criteria

• Patients must have capacity to consent
• Pregnant patients are excluded

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm A (usual care)	Laboratory Biomarker Analysis	Patients receive usual care.
Arm A (usual care)	Best Practice	Patients receive usual care.
Arm A (usual care)	Survey Administration	Patients receive usual care.
Arm B (health care coach support)	Laboratory Biomarker Analysis	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.
Arm B (health care coach support)	Survey Administration	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.
Arm B (health care coach support)	Supportive Care	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.

Primary Outcome Measures

Name	Time	Method
Emergency Department Visit (Chart Review)	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.
Hospitalization Visits (Chart Review)	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.

Secondary Outcome Measures

Name	Time	Method
Palliative Care Consult (Chart Review)	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.
Hospitalization Visits (Chart Review)	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.
Hospice Consult (Chart Review)	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.
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	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.
Change in patient satisfaction with care among patients undergoing health care coach support as assessed by Consumer Assessment of Healthcare Providers and Systems-G.	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.
Emergency Department Visit (Chart Review)	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.

Trial Locations

Locations (1)

Virginia K Crosson Cancer Center; 🇺🇸 Fullerton, California, United States