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

December 18, 2024 updated by: Manali Indravadan Patel, Stanford University

St. Judes-Stanford Comprehensive Support Initiative

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

128

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Fullerton, California, United States, 29835
        • Virginia K Crosson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Arm A (usual care)
Patients receive usual care.
Other: Laboratory Biomarker Analysis
Correlative studies
Other: Best Practice
Receive usual care
Other Names:
  • standard of care
  • standard therapy
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
Other: Survey Administration
Ancillary studies
Procedure: Supportive Care
Undergo health care coach support
Other Names:
  • Supportive Therapy
  • Symptom Management
  • Therapy, Supportive

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Emergency Department Visits (Chart Review)
Time Frame: 6 months after patient enrollment
Mean emergency department visits 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 mean numbers of emergency department visits between study arms.
6 months after patient enrollment
Number of Hospitalization Visits (Chart Review)
Time Frame: 6 months after patient enrollment
Mean 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 mean numbers of hospitalizations between the two study arms.
6 months after patient enrollment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 months after patient enrollment
Hospice Consult (Chart Review)
Time Frame: 6 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.
6 months after patient enrollment
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.
12 months after patient enrollment
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.
30 days prior to death
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 12 months after enrollment. We will evaluate comparisons of palliative care use between study arms.
6 months after patient enrollment
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.
12 months after patient enrollment
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.
30 days prior to death
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 baseline to 6 and 12 months

Each patient will receive a satisfaction with decision-making survey (The Satisfaction with Decision Survey) at baseline, 6 months, and 12 months.

Satisfaction with Decision was assessed using the Satisfaction with Decision scale, which measured rating of decision-making. Questions were assessed with responses on a scale of "strongly disagree," "disagree," "neither agree nor disagree," "agree," or "strongly agree." Results are expressed as proportion of participants who responded "strongly agree."
Change in patient satisfaction with care and decision making from baseline to 6 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.
Time Frame: Change in patient satisfaction with care from baseline to 6 and 12 months

Each patient will receive a satisfaction with care survey (The Consumer Assessment of Healthcare Providers and Systems-G) at baseline, 6 months, and 12 months.

Overall Health and Overall Mental or Emotional health was assessed using the Consumer Assessment of Health Care Providers and Systems-Clinician and Group Survey version 2.0 (cite) questions #26, which measured rating of overall health with responses, "excellent," "very good," "fair," or "poor." Questions were assessed with responses "never", "sometimes," "usually," or "always," or care rated as "worst," "fair," good", or "best." Results are expressed as proportion of participants who responded "always", or "best care."
Change in patient satisfaction with care from baseline to 6 and 12 months
Mean Emergency Department Visits (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.
12 months after patient enrollment
Number of People With Emergency Department Visit (Chart Review)
Time Frame: 30 days prior to death
Number of people with Emergency Department use in the 30 days before death will be abstracted by electronic medical record chart review for each patient who has died. We will evaluate comparisons of the number of people with emergency department visits between study arms.
30 days prior to death
Number of Patients With Hospital Use (Chart Review)
Time Frame: 30 days prior to death
Number of patients with hospital use in the 30 days before death will be abstracted by electronic medical record chart review for each patient who has died. We will evaluate comparisons of proportion of people with hospitalization use between study arms in the 30 days before death.
30 days prior to death

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Investigators

  • Principal Investigator: Manali Patel, Stanford University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 8, 2017

Primary Completion (Actual)

November 30, 2021

Study Completion (Actual)

August 30, 2022

Study Registration Dates

First Submitted

November 14, 2016

First Submitted That Met QC Criteria

May 12, 2017

First Posted (Actual)

May 16, 2017

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 18, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VAR0134

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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