Health Care Coach Support in Reducing Acute Care Use and Cost in Patients With Cancer
NCT ID: NCT03154190
Last Updated: 2025-01-24
Study Results
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View full resultsBasic Information
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COMPLETED
NA
128 participants
INTERVENTIONAL
2017-08-08
2022-08-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Arm A (usual care)
Patients receive usual care.
Best Practice
Receive usual care
Laboratory Biomarker Analysis
Correlative studies
Survey Administration
Ancillary studies
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.
Laboratory Biomarker Analysis
Correlative studies
Supportive Care
Undergo health care coach support
Survey Administration
Ancillary studies
Interventions
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Best Practice
Receive usual care
Laboratory Biomarker Analysis
Correlative studies
Supportive Care
Undergo health care coach support
Survey Administration
Ancillary studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Pregnant patients are excluded
18 Years
ALL
No
Sponsors
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Stanford University
OTHER
Responsible Party
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Manali Indravadan Patel
Assistant Professor of Medicine
Principal Investigators
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Manali Patel
Role: PRINCIPAL_INVESTIGATOR
Stanford University
Locations
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Virginia K Crosson Cancer Center
Fullerton, California, United States
Countries
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References
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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.
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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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VAR0134
Identifier Type: -
Identifier Source: org_study_id
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