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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT03154190
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Stanford University
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Manali Patel
Principal Investigator Affiliation Stanford University
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Completed
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 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
Additional Details

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.

Arms & Interventions

Arms

Active Comparator: Arm A (usual care)

Patients receive usual care.

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.

Interventions

Other: - Best Practice

Receive usual care

Other: - Laboratory Biomarker Analysis

Correlative studies

Procedure: - Supportive Care

Undergo health care coach support

Other: - Survey Administration

Ancillary studies

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Virginia K Crosson Cancer Center, Fullerton, California

Status

Address

Virginia K Crosson Cancer Center

Fullerton, California, 29835

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