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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Enrollment
2,996
All participants will receive an electronic health record message or email with standardized information provided regarding advance care planning and symptom management.
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.
University of Alabama at Birmingham
Birmingham, Alabama, United States
RECRUITINGChange 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.
Time frame: Change in health-related quality of life from baseline to 3 months
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.
Time frame: Change in health-related quality of life from baseline to 6, and 12 months
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.
Time frame: 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.
Time frame: 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.
Time frame: Change in satisfaction with decision from baseline to 3, 6, and 12 months
Palliative Care Use (Self-reported and Chart Review)
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University of South Alabama
Mobile, Alabama, United States
RECRUITINGBeckman Research Institute of City of Hope
Duarte, California, United States
RECRUITINGVA Medical Center, Fresno
Fresno, California, United States
RECRUITINGSanta Clara Valley Medical Center
Fruitdale, California, United States
RECRUITINGSt Jude Heritage Medical Group
Fullerton, California, United States
RECRUITINGOncology Institute for Hope and Innovation
Los Angeles, California, United States
RECRUITINGSacramento VA Medical Center - VA Northern California Health Care System
Mather, California, United States
ACTIVE_NOT_RECRUITINGPacific Cancer Care
Monterey, California, United States
ACTIVE_NOT_RECRUITINGVA Palo Alto
Palo Alto, California, United States
ACTIVE_NOT_RECRUITING...and 7 more locations
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 3, 6, and 12 months after patient enrollment