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| Name | Class |
|---|---|
| Patient-Centered Outcomes Research Institute | OTHER |
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This cluster-randomized comparative effectiveness trial compares a technology-based supportive cancer care (SCC) approach with a redesigned team-based supportive cancer care (SCC) approach.
PRIMARY OBJECTIVES:
I. Greater intervention effects on health-related quality of life
SECONDARY OBJECTIVES:
I. Greater intervention effects on patient activation II. Greater satisfaction with care and decision-making III. Greater documentation of goals of care and symptoms IV. To lower acute care V. Greater palliative care and hospice
OUTLINE: Sites are randomized to 1 of 2 arms.
ARM A: Patients receive educational materials to assist with advance care planning and symptom management through a technology-based supportive cancer care weekly during months 1-4 and every other week during months 5-12.
ARM B: Patients are paired with a lay health worker who will discuss the same educational materials from ARM A either in person or by telephone discussions weekly during months 1-4 and every other week during months 5-12.
All participants complete a baseline interview upon enrollment during the initial consent phone contact and then a survey at 3-, 6-and 12-months post enrollment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Technology-based supportive cancer care | Active Comparator | Patients receive educational materials to assist with advance care planning and symptom management through a technology-based supportive cancer care weekly during months 1-4 and every other week during months 5-12. |
|
| Redesigned team-based supportive cancer care | Experimental | Patients are paired with a health educator who will discuss the same educational materials from ARM A either in person or by telephone discussions weekly during months 1-4 and every other week during months 5-12. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Receive technology-based supportive cancer care | Other | All participants will receive an electronic health record message or email with standardized information provided regarding advance care planning and symptom management. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in health-related quality of life as assessed by the Functional Assessment of Cancer Therapy (FACT-G). | Each patient will receive a health-related quality of life survey (FACT-G) at baseline, 3 months, 6 months, and 12 months. | Change in health-related quality of life from baseline to 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in health-related quality of life as assessed by the Functional Assessment of Cancer Therapy (FACT-G). | Each patient will receive a health-related quality of life survey (FACT-G) at baseline, 3 months, 6 months, and 12 months. | Change in health-related quality of life from baseline to 6, and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Time Toxicity | Each patient will receive a time toxicity survey at baseline, 3 months, 6 months and 12 months. | 3, 6, and 12 months after patient enrollment |
| Financial Toxicity | Each patient will receive the validated COmprehensive Score for financial Toxicity (COST)-Functional Assessment of Chronic Illness Therapy (COST-FACIT) questionnaire at baseline, 3 months, 6 months, and 12 months. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Manali I Patel, MD MPH MS | Contact | 6507234000 | manalip@stanford.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Recruiting | Birmingham | Alabama | 35294 | United States |
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Cluster Randomized Controlled Trial among 26 clinics
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| Receive redesigned team-based supportive cancer care | Behavioral | Lay Health Workers will meet with 1:1 with participants over 12 months to discuss advance care planning, surrogate decision-makers, advance directives and physician orders for life sustaining treatment. |
|
|
| Change in patient activation using the Patient Activation Measure (PAM-13). |
Each patient will receive a validated patient activation survey (PAM-13) to assess their activation at baseline, 3 months, 6 months, and 12 months. |
| Change in patient activation from baseline to 3, 6, and 12 months |
| Change in satisfaction with care using the Consumer Assessment of Health Care (Providers and Systems (CAHPS) Cancer Care Survey Questions #39 and #42. | Each patient will receive a validated satisfaction with care survey at baseline, 3 months, 6 months, and 12 months. | Change in satisfaction with care from baseline to 3, 6, and 12 months |
| Change in satisfaction with decision using the Satisfaction with Decision Scale (SWD) | Each patient will receive a validated satisfaction with decision survey at baseline, 3 months, 6 months and 12 months. | Change in satisfaction with decision from baseline to 3, 6, and 12 months |
| Palliative Care Use (Self-reported and Chart Review) | Palliative care use will be self-reported by each patient or abstracted by electronic medical record at 3, 6 and 12 months after patient enrollment. | 3, 6, and 12 months after patient enrollment |
| Hospice Care Use (Self-reported and Chart Review) | Hospice care use will be self-reported by each patient or abstracted by electronic medical record at 3, 6, and 12 months after patient enrollment. | 3, 6, and 12 months after patient enrollment |
| Emergency Department Visits (Self-reported and Chart Review) | Emergency Department use will be self-reported by each patient or abstracted by electronic medical record at 3, 6, and 12 months after enrollment. | 3, 6, and 12 months after patient enrollment |
| Hospitalization Visits (Self-reported and Chart Review) | Hospital use for each patient will be self-reported by each patient or abstracted by electronic medical record at 3, 6, and 12 months after enrollment. | 3, 6, and 12 months after patient enrollment |
| Documentation of goals of care discussions (Chart Review) | Documentation of goals of care discussions will be abstracted by electronic medical record chart review for each patient at 3, 6, and 12 months after enrollment. | 3, 6, and 12 months after patient enrollment |
| Documentation of symptom discussions (Chart Review) | Documentation of symptom discussions will be abstracted by electronic medical record chart review for each patient at 3, 6, and 12 months after enrollment. | 3, 6, and 12 months after patient enrollment |
| 3, 6, and 12 months after patient enrollment |
| University of South Alabama | Recruiting | Mobile | Alabama | 36688 | United States |
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| Beckman Research Institute of City of Hope | Recruiting | Duarte | California | 91010 | United States |
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| VA Medical Center, Fresno | Recruiting | Fresno | California | 93703 | United States |
| Santa Clara Valley Medical Center | Recruiting | Fruitdale | California | 95128 | United States |
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| St Jude Heritage Medical Group | Recruiting | Fullerton | California | 92835 | United States |
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| Oncology Institute for Hope and Innovation | Recruiting | Los Angeles | California | 90017 | United States |
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| Sacramento VA Medical Center - VA Northern California Health Care System | Active, not recruiting | Mather | California | 95655 | United States |
| Pacific Cancer Care | Active, not recruiting | Monterey | California | 93940 | United States |
| VA Palo Alto | Active, not recruiting | Palo Alto | California | 94305 | United States |
| Zuckerberg San Francisco General | Recruiting | San Francisco | California | 94110 | United States |
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| Kaiser Foundation Research Institute | Recruiting | San Francisco | California | 94115 | United States |
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| University of San Francisco | Recruiting | San Francisco | California | 94117 | United States |
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| San Francisco VA Medical Center | Active, not recruiting | San Francisco | California | 94121 | United States |
| Spark M. Matsunaga VA Medical Center | Recruiting | Honolulu | Hawaii | 96819 | United States |
| North Las Vegas VA Medical Center | Active, not recruiting | Las Vegas | Nevada | 89086 | United States |
| George E. Wahlen Department of Veterans Affairs Medical Center | Recruiting | Salt Lake City | Utah | 84148 | United States |
| ID | Term |
|---|---|
| D003643 | Death |
| D009369 | Neoplasms |
| D002277 | Carcinoma |
| D008175 | Lung Neoplasms |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D008545 | Melanoma |
| D010190 | Pancreatic Neoplasms |
| D012509 | Sarcoma |
| D010051 | Ovarian Neoplasms |
| D000077216 | Carcinoma, Ovarian Epithelial |
| D013274 | Stomach Neoplasms |
| D005909 | Glioblastoma |
| D012004 | Rectal Neoplasms |
| D003110 | Colonic Neoplasms |
| D004938 | Esophageal Neoplasms |
| D001943 | Breast Neoplasms |
| D002292 | Carcinoma, Renal Cell |
| D012878 | Skin Neoplasms |
| D055752 | Small Cell Lung Carcinoma |
| D012516 | Osteosarcoma |
| D009190 | Myelodysplastic Syndromes |
| D018450 | Disease Progression |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D014565 | Urogenital Neoplasms |
| D002283 | Carcinoma, Bronchogenic |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001984 | Bronchial Neoplasms |
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D004067 | Digestive System Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D018204 | Neoplasms, Connective and Soft Tissue |
| 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 |
| D000091662 | Genital Diseases |
| D006058 | Gonadal Disorders |
| D005770 | Gastrointestinal Neoplasms |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
| D001254 | Astrocytoma |
| D005910 | Glioma |
| D018302 | Neoplasms, Neuroepithelial |
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D003108 | Colonic Diseases |
| D006258 | Head and Neck Neoplasms |
| D004935 | Esophageal Diseases |
| D001941 | Breast Diseases |
| D000230 | Adenocarcinoma |
| D007680 | Kidney Neoplasms |
| D014571 | Urologic Neoplasms |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D018213 | Neoplasms, Bone Tissue |
| D009372 | Neoplasms, Connective Tissue |
| D001855 | Bone Marrow Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D020969 | Disease Attributes |
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