Comparative Effectiveness Trial of Two Supportive Cancer Care Delivery Models for Adults With Cancer
Summary
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.
Detailed description
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.
Arms & interventions
- OtherReceive technology-based supportive cancer care
All participants will receive an electronic health record message or email with standardized information provided regarding advance care planning and symptom management.
- BehavioralReceive redesigned team-based supportive cancer care
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.
Outcome measures
Primary
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 3 months
Secondary
Change in health-related quality of life as assessed by the Functional Assessment of Cancer Therapy (FACT-G).
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).
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.
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)
Time frame: Change in satisfaction with decision from baseline to 3, 6, and 12 months
Palliative Care Use (Self-reported and Chart Review)
Time frame: 3, 6, and 12 months after patient enrollment
Hospice Care Use (Self-reported and Chart Review)
Time frame: 3, 6, and 12 months after patient enrollment
Emergency Department Visits (Self-reported and Chart Review)
Time frame: 3, 6, and 12 months after patient enrollment
Hospitalization Visits (Self-reported and Chart Review)
Time frame: 3, 6, and 12 months after patient enrollment
Documentation of goals of care discussions (Chart Review)
Time frame: 3, 6, and 12 months after patient enrollment
Documentation of symptom discussions (Chart Review)
Time frame: 3, 6, and 12 months after patient enrollment
Eligibility criteria
Study locations (17)
University of Alabama at Birmingham
Birmingham, Alabama, 35294
University of South Alabama
Mobile, Alabama, 36688
Beckman Research Institute of City of Hope
Duarte, California, 91010
VA Medical Center, Fresno
Fresno, California, 93703
Santa Clara Valley Medical Center
Fruitdale, California, 95128
St Jude Heritage Medical Group
Fullerton, California, 92835
Oncology Institute for Hope and Innovation
Los Angeles, California, 90017
Sacramento VA Medical Center - VA Northern California Health Care System
Mather, California, 95655
Pacific Cancer Care
Monterey, California, 93940
VA Palo Alto
Palo Alto, California, 94305
Zuckerberg San Francisco General
San Francisco, California, 94110
Kaiser Foundation Research Institute
San Francisco, California, 94115
University of San Francisco
San Francisco, California, 94117
San Francisco VA Medical Center
San Francisco, California, 94121
Spark M. Matsunaga VA Medical Center
Honolulu, Hawaii, 96819
North Las Vegas VA Medical Center
Las Vegas, Nevada, 89086
George E. Wahlen Department of Veterans Affairs Medical Center
Salt Lake City, Utah, 84148