Clinical trial NCT03154190: Health Care Coach Support in Reducing Acute Care Use and Cost in Patients With Cancer
Official title: St. Judes-Stanford Comprehensive Support Initiative
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Myeloid Leukemia
Brain Glioblastoma
Estrogen Receptor Negative
Extensive Stage Small Cell Lung Carcinoma
Head and Neck Carcinoma
HER2/Neu Negative
Hormone-Resistant Prostate Cancer
Limited Stage Small Cell Lung Carcinoma
Myelodysplastic Syndrome
Progesterone Receptor Negative
Progressive Disease
Recurrent Carcinoma
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
Triple-Negative Breast Carcinoma
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2017-05-16
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Emergency Department Visits (Chart Review)
timeFrame: 6 months after patient enrollment
measure: Number of Hospitalization Visits (Chart Review)
timeFrame: 6 months after patient enrollment
Secondary outcomes:
measure: 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
timeFrame: Change in patient satisfaction with care and decision making from baseline to 6 and 12 months
measure: Change in Patient Satisfaction With Care Among Patients Undergoing Health Care Coach Support as Assessed by Consumer Assessment of Healthcare Providers and Systems-G.
timeFrame: Change in patient satisfaction with care from baseline to 6 and 12 months
measure: Mean Emergency Department Visits (Chart Review)
timeFrame: 12 months after patient enrollment
measure: Number of People With Emergency Department Visit (Chart Review)
timeFrame: 30 days prior to death
measure: Hospitalization Visits (Chart Review)
timeFrame: 12 months after patient enrollment
measure: Number of Patients With Hospital Use (Chart Review)
timeFrame: 30 days prior to death
measure: Hospice Consult (Chart Review)
timeFrame: 6 months after patient enrollment
measure: Hospice Consult (Chart Review)
timeFrame: 12 months after patient enrollment
measure: Hospice Consult (Chart Review)
timeFrame: 30 days prior to death
measure: Palliative Care Consult (Chart Review)
timeFrame: 6 months after patient enrollment
measure: Palliative Care Consult (Chart Review)
timeFrame: 12 months after patient enrollment
measure: Palliative Care Consult (Chart Review)
timeFrame: 30 days prior to death
Other outcomes:
Locations:
city: Fullerton
country: United States
facility: Virginia K Crosson Cancer Center
state: California
Study officials:
affiliation: Stanford University
name: Manali Patel
role: PRINCIPAL_INVESTIGATOR
References:
citation: Patel MI, Kapphahn K, Dewland M, Aguilar V, Sanchez B, Sisay E, Murillo A, Smith K, Park DJ. Effect of a Community Health Worker Intervention on Acute Care Use, Advance Care Planning, and Patient-Reported Outcomes Among Adults With Advanced Stages of Cancer: A Randomized Clinical Trial. JAMA Oncol. 2022 Aug 1;8(8):1139-1148. doi: 10.1001/jamaoncol.2022.1997.
citation: Patel MI, Aguilar V, Sanchez B, Sisay E, Park DJ. Health care coach support to assist with advance care planning and symptom management -A randomized controlled trial. Contemp Clin Trials. 2021 Dec;111:106617. doi: 10.1016/j.cct.2021.106617. Epub 2021 Nov 5.