Comparative Effectiveness Trial of Two Supportive Cancer Care Delivery Models for Adults With Cancer
Part of paid clinical trials in Birmingham, Alabama.
- Sponsor
- Stanford University
- Study ID
- NCT05297734
- Status
- Recruiting
Conditions
- Cancer
- End of Life
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Receive technology-based supportive cancer care — OTHERAll participants will receive an electronic health record message or email with standardized information provided regarding advance care planning and symptom management.
- Receive redesigned team-based supportive cancer care — BEHAVIORALLay 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.
Study Details
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.
Key Dates
- Start date
- Jun 24, 2022
- Status verified
- Apr 2026
- Primary completion
- Jan 31, 2028
- Completion
- Feb 28, 2028
Study Design
- Enrollment
- 2,996 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- HEALTH_SERVICES_RESEARCH
Arms
- Active Comparator: Technology-based supportive cancer carePatients 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.
- Experimental: Redesigned team-based supportive cancer carePatients 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.
Primary Outcome Measure
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 3 months ]
Central Contacts
- Manali I Patel, MD MPH MS6507234000
Locations (17)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | Gabrielle Rocque, MD |
| University of South Alabama | Mobile | Alabama | 36688 | Jennifer Y Pierce, MD |
| Beckman Research Institute of City of Hope | Duarte | California | 91010 | Finly Zachariah, MD 800-826-4673 |
| VA Medical Center, Fresno | Fresno | California | 93703 | - |
| Santa Clara Valley Medical Center | Fruitdale | California | 95128 | Sangeeta Aggarwal, MD |
| St Jude Heritage Medical Group | Fullerton | California | 92835 | David Park, MD |
| Oncology Institute for Hope and Innovation | Los Angeles | California | 90017 | Richy Agajanian, MD |
| 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 | - |
| Kaiser Foundation Research Institute | San Francisco | California | 94115 | Raymond Liu, MD |
| San Francisco VA Medical Center | San Francisco | California | 94121 | - |
| University of San Francisco | San Francisco | California | 94117 | Kim Rhoads, MD |
| Zuckerberg San Francisco General | San Francisco | California | 94110 | Niharika Dixit, MD |
| 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 | - |
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