NCT03154190

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
128

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 14, 2016

Completed
6 months until next milestone

First Posted

Study publicly available on registry

May 16, 2017

Completed
3 months until next milestone

Study Start

First participant enrolled

August 8, 2017

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2021

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2022

Completed
2.4 years until next milestone

Results Posted

Study results publicly available

January 24, 2025

Completed
Last Updated

January 24, 2025

Status Verified

December 1, 2024

Enrollment Period

4.3 years

First QC Date

November 14, 2016

Results QC Date

August 25, 2022

Last Update Submit

December 18, 2024

Conditions

Acute Myeloid LeukemiaBrain GlioblastomaEstrogen Receptor NegativeExtensive Stage Small Cell Lung CarcinomaHead and Neck CarcinomaHER2/Neu NegativeHormone-Resistant Prostate CancerLimited Stage Small Cell Lung CarcinomaMyelodysplastic SyndromeProgesterone Receptor NegativeProgressive DiseaseRecurrent CarcinomaStage II Pancreatic CancerStage II Rectal CancerStage IIA Pancreatic CancerStage IIA Rectal CancerStage IIB Pancreatic CancerStage IIB Rectal CancerStage IIC Rectal CancerStage III Colon CancerStage III Esophageal CancerStage III Gastric CancerStage III Non-Small Cell Lung CancerStage III Ovarian CancerStage III Pancreatic CancerStage III Rectal CancerStage III Skin MelanomaStage IIIA Colon CancerStage IIIA Esophageal CancerStage IIIA Gastric CancerStage IIIA Non-Small Cell Lung CancerStage IIIA Ovarian CancerStage IIIA Rectal CancerStage IIIA Skin MelanomaStage IIIB Colon CancerStage IIIB Esophageal CancerStage IIIB Gastric CancerStage IIIB Non-Small Cell Lung CancerStage IIIB Ovarian CancerStage IIIB Rectal CancerStage IIIB Skin MelanomaStage IIIC Colon CancerStage IIIC Esophageal CancerStage IIIC Gastric CancerStage IIIC Ovarian CancerStage IIIC Rectal CancerStage IIIC Skin MelanomaStage IV Bladder CancerStage IV Bone SarcomaStage IV Breast CancerStage IV Colon CancerStage IV Esophageal CancerStage IV Gastric CancerStage IV Non-Small Cell Lung CancerStage IV Ovarian CancerStage IV Pancreatic CancerStage IV Rectal CancerStage IV Renal Cell CancerStage IV Skin MelanomaStage IV Soft Tissue SarcomaStage IVA Bone SarcomaStage IVA Colon CancerStage IVA Rectal CancerStage IVB Bone SarcomaStage IVB Colon CancerStage IVB Rectal CancerTriple-Negative Breast Carcinoma

Outcome Measures

Primary Outcomes (2)

  • Number of Emergency Department Visits (Chart Review)

    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)

    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 Outcomes (12)

  • 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 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.

    Change in patient satisfaction with care from baseline to 6 and 12 months

  • Mean Emergency Department Visits (Chart Review)

    12 months after patient enrollment

  • Number of People With Emergency Department Visit (Chart Review)

    30 days prior to death

  • Hospitalization Visits (Chart Review)

    12 months after patient enrollment

  • +7 more secondary outcomes

Study Arms (2)

Arm A (usual care)

ACTIVE COMPARATOR

Patients receive usual care.

Other: Best PracticeOther: Laboratory Biomarker AnalysisOther: Survey Administration

Arm B (health care coach support)

EXPERIMENTAL

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 AnalysisProcedure: Supportive CareOther: Survey Administration

Interventions

Best PracticeOTHER

Receive usual care

Also known as: standard of care, standard therapy
Arm A (usual care)
Laboratory Biomarker AnalysisOTHER

Correlative studies

Arm A (usual care)Arm B (health care coach support)
Supportive CarePROCEDURE

Undergo health care coach support

Also known as: Supportive Therapy, Symptom Management, Therapy, Supportive
Arm B (health care coach support)
Survey AdministrationOTHER

Ancillary studies

Arm A (usual care)Arm B (health care coach support)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • +7 more criteria

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Virginia K Crosson Cancer Center

Fullerton, California, 29835, United States

Location

Related Publications (2)

  • 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.

    PMID: 35771552DERIVED

  • 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.

    PMID: 34749008DERIVED

MeSH Terms

Conditions

Leukemia, Myeloid, AcuteMyelodysplastic SyndromesDisease ProgressionRecurrencePancreatic NeoplasmsRectal NeoplasmsColonic NeoplasmsEsophageal NeoplasmsStomach NeoplasmsCarcinoma, Non-Small-Cell LungOvarian NeoplasmsMelanomaUrinary Bladder NeoplasmsBone NeoplasmsBreast NeoplasmsCarcinoma, Renal CellSarcomaTriple Negative Breast Neoplasms

Interventions

Practice Guidelines as TopicStandard of CarePalliative Care

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesBone Marrow DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsDigestive System NeoplasmsNeoplasms by SiteEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System DiseasesColorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsGastrointestinal DiseasesIntestinal DiseasesRectal DiseasesColonic DiseasesHead and Neck NeoplasmsEsophageal DiseasesStomach DiseasesCarcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsLung DiseasesRespiratory Tract DiseasesOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesGonadal DisordersNeuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsSkin DiseasesSkin and Connective Tissue DiseasesUrologic NeoplasmsUrinary Bladder DiseasesUrologic DiseasesMale Urogenital DiseasesBone DiseasesMusculoskeletal DiseasesBreast DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialKidney NeoplasmsKidney DiseasesNeoplasms, Connective and Soft Tissue

Intervention Hierarchy (Ancestors)

Guidelines as TopicQuality Assurance, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and EvaluationQuality Indicators, Health CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Results Point of Contact

Title
Manali Patel
Organization
Stanford University School of Medicine
manalip@stanford.edu
650-723-4000

Study Officials

  • Manali Patel

    Stanford University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Medicine

Study Record Dates

First Submitted

November 14, 2016

First Posted

May 16, 2017

Study Start

August 8, 2017

Primary Completion

November 30, 2021

Study Completion

August 30, 2022

Last Updated

January 24, 2025

Results First Posted

January 24, 2025

Record last verified: 2024-12

Locations

US(1)