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BRIEF TITLE: St. Judes-Stanford Comprehensive Support Initiative

St. Judes-Stanford Comprehensive Support Initiative


  • Org Study ID: VAR0134
  • Secondary ID:
  • NCT ID: NCT03154190
  • NCT Alias:
  • Sponsor: Stanford University - Other
  • Source: Stanford University

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.

Overal Status Start Date Phase Study Type
Recruiting December 15, 2016 N/A Interventional

Primary Outcomes:

Primary Outcome 1 - Measure: Emergency Department Visit (Chart Review)

Primary Outcome 1 - Time Frame: 6 months after patient enrollment

Primary Outcome 2 - Measure: Hospitalization Visits (Chart Review)

Primary Outcome 2 - Time Frame: 6 months after patient enrollment

Primary Outcome 3 - Measure: Hospice Consult (Chart Review)

Primary Outcome 3 - Time Frame: 6 months after patient enrollment

Primary Outcome 4 - Measure: Palliative Care Consult (Chart Review)

Primary Outcome 4 - Time Frame: 6 months after patient enrollment

Condition:

  • 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

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
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Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Official Information

Name: Manali Patel

Role: Principal Investigator

Affiliation: Stanford University

Overall Contact

Name: Manali Patel

Phone:

Email: manalip@stanford.edu

Location

Facility Status Contact
Virginia K Crosson Cancer Center
Fullerton, California 29835
United States
Recruiting David J. Park

david.park@stjoe.org