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Completed

NCT Number: NCT03154190

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

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.

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Key information

Conditions

Acute Myeloid Leukemia Adenocarcinoma Adnexal Diseases Bone Diseases Bone Marrow Diseases Bone Neoplasms Brain Glioblastoma Breast Diseases Breast Neoplasms Bronchial Neoplasms Carcinoma Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Carcinoma, Renal Cell Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Disease Attributes Disease Progression Endocrine Gland Neoplasms Endocrine System Diseases Esophageal Diseases Esophageal Neoplasms Estrogen Receptor Negative Extensive Stage Small Cell Lung Carcinoma Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastrointestinal Diseases Gastrointestinal Neoplasms Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders HER2/Neu Negative Head and Neck Carcinoma Head and Neck Neoplasms Hematologic Diseases Hemic and Lymphatic Diseases Hormone-Resistant Prostate Cancer Intestinal Diseases Intestinal Neoplasms Kidney Diseases Kidney Neoplasms Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Limited Stage Small Cell Lung Carcinoma Lung Diseases Lung Neoplasms Male Urogenital Diseases Melanoma Musculoskeletal Diseases Myelodysplastic Syndrome Myelodysplastic Syndromes Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Connective and Soft Tissue Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Ovarian Diseases Ovarian Neoplasms Pancreatic Diseases Pancreatic Neoplasms Pathologic Processes Pathological Conditions, Signs and Symptoms Progesterone Receptor Negative Progressive Disease Rectal Diseases Rectal Neoplasms Recurrence Recurrent Carcinoma Respiratory Tract Diseases Respiratory Tract Neoplasms Sarcoma Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases 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 Stomach Diseases Stomach Neoplasms Thoracic Neoplasms Triple Negative Breast Neoplasms Triple-Negative Breast Carcinoma Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Virginia K Crosson Cancer Center

Fullerton, California, 29835, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Best Practice

Other

Receive usual care

Other names: standard of care, standard therapy

laboratory biomarker analysis

Other

Correlative studies

Supportive Care

Procedure

Undergo health care coach support

Other names: Supportive Therapy, Symptom Management, Therapy, Supportive

Survey Administration

Other

Ancillary studies

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  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 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."

  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 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."

  3. 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.

  4. 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.

  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. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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. 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.

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Official study title

St. Judes-Stanford Comprehensive Support Initiative

Important dates

Study start
2017
Primary completion
2021
Study completion
2022
First posted
May 16, 2017
Registry last updated
Jan 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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