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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A (usual care) | Active Comparator | Patients receive usual care. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Best Practice | Other | Receive usual care |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 baseline, 6 months, and 12 months. Satisfaction with Decision was assessed using the Satisfaction with Decision scale, which measured rating of decision-making. Questions were assessed with responses on a scale of "strongly disagree," "disagree," "neither agree nor disagree," "agree," or "strongly agree." Results are expressed as proportion of participants who responded "strongly agree." |
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Inclusion Criteria:
Newly diagnosed patients for the following conditions
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:
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| Name | Affiliation | Role |
|---|---|---|
| Manali Patel | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Virginia K Crosson Cancer Center | Fullerton | California | 29835 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35771552 | Derived | 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. | |
| 34749008 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm A (Usual Care) | Patients receive usual care. Best Practice: Receive usual care Laboratory Biomarker Analysis: Correlative studies Survey Administration: Ancillary studies |
| FG001 | Arm B (Health Care Coach Support) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 18, 2016 |
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| Laboratory Biomarker Analysis | Other | Correlative studies |
|
| Supportive Care | Procedure | Undergo health care coach support |
|
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| Survey Administration | Other | Ancillary studies |
|
| 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. | Each patient will receive a satisfaction with care survey (The Consumer Assessment of Healthcare Providers and Systems-G) at baseline, 6 months, and 12 months. Overall Health and Overall Mental or Emotional health was assessed using the Consumer Assessment of Health Care Providers and Systems-Clinician and Group Survey version 2.0 (cite) questions #26, which measured rating of overall health with responses, "excellent," "very good," "fair," or "poor." Questions were assessed with responses "never", "sometimes," "usually," or "always," or care rated as "worst," "fair," good", or "best." Results are expressed as proportion of participants who responded "always", or "best care." | Change in patient satisfaction with care from baseline to 6 and 12 months |
| Mean Emergency Department Visits (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 |
| Number of People With Emergency Department Visit (Chart Review) | Number of people with Emergency Department use in the 30 days before death will be abstracted by electronic medical record chart review for each patient who has died. We will evaluate comparisons of the number of people with emergency department visits between study arms. | 30 days prior to death |
| 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 |
| Number of Patients With Hospital Use (Chart Review) | Number of patients with hospital use in the 30 days before death will be abstracted by electronic medical record chart review for each patient who has died. We will evaluate comparisons of proportion of people with hospitalization use between study arms in the 30 days before death. | 30 days prior to death |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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. |
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
| 6 Months |
|
| COMPLETED |
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| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm A (Usual Care) | Patients receive usual care. Best Practice: Receive usual care Laboratory Biomarker Analysis: Correlative studies Survey Administration: Ancillary studies |
| BG001 | 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 |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||
| Sex/Gender, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Education Level | Count of Participants | Participants |
| ||||||||||||||||
| Insurance Status | Count of Participants | Participants |
| ||||||||||||||||
| Anatomic Site of Cancer Diagnosis | Count of Participants | Participants |
| ||||||||||||||||
| Cancer Stage at Diagnosis | Count of Participants | Participants |
| ||||||||||||||||
| Cancer-Directed Treatment | Number | participants |
| ||||||||||||||||
| Recurrent Cancer - no | Count of Participants | Participants |
| ||||||||||||||||
| Symptom Burden | Symptom-burden was assessed by summing 10 items of the Edmonton Assessment Scale (0-10) resulting in a range from 0-100. Lower scores indicate better symptom control, while higher scores indicated worse symptoms by patients with cancer. | Mean | Standard Deviation | score on a scale |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | visits | 6 months after patient enrollment |
|
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| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | 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. | Posted | Mean | Standard Deviation | visits | 6 months after patient enrollment |
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| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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 baseline, 6 months, and 12 months. Satisfaction with Decision was assessed using the Satisfaction with Decision scale, which measured rating of decision-making. Questions were assessed with responses on a scale of "strongly disagree," "disagree," "neither agree nor disagree," "agree," or "strongly agree." Results are expressed as proportion of participants who responded "strongly agree." | Participants who completed the survey at each respective time point are included in the analysis. | Posted | Count of Participants | Participants | Change in patient satisfaction with care and decision making from baseline to 6 and 12 months |
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| 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 baseline, 6 months, and 12 months. Overall Health and Overall Mental or Emotional health was assessed using the Consumer Assessment of Health Care Providers and Systems-Clinician and Group Survey version 2.0 (cite) questions #26, which measured rating of overall health with responses, "excellent," "very good," "fair," or "poor." Questions were assessed with responses "never", "sometimes," "usually," or "always," or care rated as "worst," "fair," good", or "best." Results are expressed as proportion of participants who responded "always", or "best care." | Participants who completed the survey at each respective time point are included in the analysis. | Posted | Count of Participants | Participants | Change in patient satisfaction with care from baseline to 6 and 12 months |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Emergency Department Visits (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. | Posted | Mean | Standard Deviation | mean visits per year | 12 months after patient enrollment |
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| Secondary | Number of People With Emergency Department Visit (Chart Review) | Number of people with Emergency Department use in the 30 days before death will be abstracted by electronic medical record chart review for each patient who has died. We will evaluate comparisons of the number of people with emergency department visits between study arms. | Posted | Count of Participants | Participants | 30 days prior to death |
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| 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. | Posted | Mean | Standard Deviation | visits | 12 months after patient enrollment |
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| Secondary | Number of Patients With Hospital Use (Chart Review) | Number of patients with hospital use in the 30 days before death will be abstracted by electronic medical record chart review for each patient who has died. We will evaluate comparisons of proportion of people with hospitalization use between study arms in the 30 days before death. | Posted | Count of Participants | Participants | 30 days prior to death |
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| 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. | Posted | Count of Participants | Participants | 6 months after patient enrollment |
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| 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. | Posted | Count of Participants | Participants | 12 months after patient enrollment |
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| 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. | Posted | Count of Participants | Participants | 30 days prior to death |
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| 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. | Posted | Count of Participants | Participants | 6 months after patient enrollment |
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| 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. | Posted | Count of Participants | Participants | 12 months after patient enrollment |
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| 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. | Posted | Count of Participants | Participants | 30 days prior to death |
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|
1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm A (Usual Care) | Patients receive usual care. Best Practice: Receive usual care Laboratory Biomarker Analysis: Correlative studies Survey Administration: Ancillary studies | 26 | 64 | 0 | 64 | 0 | 64 |
| EG001 | 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 | 32 | 64 | 0 | 64 | 0 | 64 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Manali Patel | Stanford University School of Medicine | 650-723-4000 | manalip@stanford.edu |
| Dec 10, 2024 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| D009190 | Myelodysplastic Syndromes |
| D018450 | Disease Progression |
| D012008 | Recurrence |
| D010190 | Pancreatic Neoplasms |
| D012004 | Rectal Neoplasms |
| D003110 | Colonic Neoplasms |
| D004938 | Esophageal Neoplasms |
| D013274 | Stomach Neoplasms |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D010051 | Ovarian Neoplasms |
| D008545 | Melanoma |
| D001749 | Urinary Bladder Neoplasms |
| D001859 | Bone Neoplasms |
| D001943 | Breast Neoplasms |
| D002292 | Carcinoma, Renal Cell |
| D012509 | Sarcoma |
| D064726 | Triple Negative Breast Neoplasms |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D001855 | Bone Marrow Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D003108 | Colonic Diseases |
| D006258 | Head and Neck Neoplasms |
| D004935 | Esophageal Diseases |
| D013272 | Stomach Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D006058 | Gonadal Disorders |
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D014571 | Urologic Neoplasms |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D001941 | Breast Diseases |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D007680 | Kidney Neoplasms |
| D007674 | Kidney Diseases |
| D018204 | Neoplasms, Connective and Soft Tissue |
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| ID | Term |
|---|---|
| D017410 | Practice Guidelines as Topic |
| D059039 | Standard of Care |
| D010166 | Palliative Care |
| ID | Term |
|---|---|
| D017408 | Guidelines as Topic |
| D011785 | Quality Assurance, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
| D019984 | Quality Indicators, Health Care |
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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| Male |
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| Non-binary |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Some High School |
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| High School Graduate or GED |
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| 4-Year College Graduate |
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| Some College or 2-Year Degree |
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| More than 4-Year College Graduate |
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| Prefer Not To Answer |
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| Medicaid |
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| Private |
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| Uninsured |
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| Genitourinary |
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| Gastrointestinal |
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| Breast |
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| Thoracic |
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| Malignant Hematologic |
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| Head and Neck |
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| Melanoma |
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| Glioblastoma |
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| Unknown Primary |
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| 4 |
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| Not applicable (i.e., Leukemia, Glioblastoma) |
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| Radiation |
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| Surgery |
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