Acute Myeloid Leukemia Clinical Trial
Official title:
St. Judes-Stanford Comprehensive Support Initiative
Verified date | January 2022 |
Source | Stanford University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 128 |
Est. completion date | August 30, 2022 |
Est. primary completion date | November 30, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Virginia K Crosson Cancer Center | Fullerton | California |
Lead Sponsor | Collaborator |
---|---|
Stanford University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Emergency Department Visit (Chart Review) | Emergency Department 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 emergency department visits between study arms. | 6 months after patient enrollment | |
Primary | Hospitalization Visits (Chart Review) | 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 hospitalizations between the two study arms. | 6 months after patient enrollment | |
Secondary | 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 | Each patient will receive a satisfaction with decision-making survey (The Satisfaction with Decision Survey) at 3 months, 6 months, 9 months, and 12 months. | Change in patient satisfaction with care and decision making from 3 months to 6, 9, and 12 months | |
Secondary | Change in patient satisfaction with care among patients undergoing health care coach support as assessed by Consumer Assessment of Healthcare Providers and Systems-G. | Each patient will receive a satisfaction with care survey (The Consumer Assessment of Healthcare Providers and Systems-G) at 3 months, 6 months, 9 months, and 12 months. | Change in patient satisfaction with care from 3 months to 6, 9, and 12 months | |
Secondary | Emergency Department Visit (Chart Review) | Emergency Department use for each patient will be abstracted by electronic medical record chart review for each patient at 12 months after enrollment. We will evaluate comparisons of emergency department visits between study arms. | 12 months after patient enrollment | |
Secondary | Emergency Department Visit (Chart Review) | Emergency Department use for each patient will be abstracted by electronic medical record chart review for each patient who has died. We will evaluate comparisons of emergency department visits between study arms. | 30 days prior to death | |
Secondary | Hospitalization Visits (Chart Review) | Hospital use for each patient will be abstracted by electronic medical record chart review for each patient at 12 months after enrollment. We will evaluate comparisons of hospitalization use between study arms. | 12 months after patient enrollment | |
Secondary | Hospitalization Visits (Chart Review) | Hospital use for each patient will be abstracted by electronic medical record chart review for each patient who has died. We will evaluate comparisons of hospitalization use between study arms. | 30 days prior to death | |
Secondary | Hospice Consult (Chart Review) | Hospice use for each patient will be abstracted by electronic medical record chart review for each patient at 12 months after enrollment. We will evaluate comparisons of hospice use between study arms. | 6 months after patient enrollment | |
Secondary | Hospice Consult (Chart Review) | Hospice use for each patient will be abstracted by electronic medical record chart review for each patient at 12 months after enrollment. We will evaluate comparisons of hospice use between study arms. | 12 months after patient enrollment | |
Secondary | Hospice Consult (Chart Review) | Hospice use for each patient will be abstracted by electronic medical record chart review for each patient who has died. We will evaluate comparisons of hospice use between study arms. | 30 days prior to death | |
Secondary | Palliative Care Consult (Chart Review) | Palliative Care consult for each patient will be abstracted by electronic medical record chart review for each patient at 12 months after enrollment. We will evaluate comparisons of palliative care use between study arms. | 6 months after patient enrollment | |
Secondary | Palliative Care Consult (Chart Review) | Palliative Care consult for each patient will be abstracted by electronic medical record chart review for each patient at 12 months after enrollment. We will evaluate comparisons of palliative care use between study arms. | 12 months after patient enrollment | |
Secondary | Palliative Care Consult (Chart Review) | Palliative Care consult for each patient will be abstracted by electronic medical record chart review for each patient who has died. We will evaluate comparisons of palliative care use between study arms. | 30 days prior to death |
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