Comparative Effectiveness Trial of Two Supportive Cancer Care Delivery Models for Adults With Cancer
NCT ID: NCT05297734
Last Updated: 2025-03-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
2996 participants
INTERVENTIONAL
2022-06-24
2028-02-28
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
SINGLE
Study Groups
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Technology-based supportive cancer care
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.
Receive 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.
Redesigned team-based supportive cancer care
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.
Receive 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.
Interventions
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Receive 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.
Receive 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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Patients must have the ability to understand and willingness to provide verbal consent.
3. Participants must speak English, Spanish, Chinese, or Vietnamese.
Exclusion Criteria
2. Plans to change oncologist within 12 months
3. Employed by the practice site
4. Patients who anticipate moving from the area within 12 months
18 Years
ALL
No
Sponsors
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Patient-Centered Outcomes Research Institute
OTHER
Stanford University
OTHER
Responsible Party
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Manali Indravadan Patel
Assistant Professor of Medicine
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
University of South Alabama
Mobile, Alabama, United States
Beckman Research Institute of City of Hope
Duarte, California, United States
VA Medical Center, Fresno
Fresno, California, United States
Santa Clara Valley Medical Center
Fruitdale, California, United States
St Jude Heritage Medical Group
Fullerton, California, United States
Oncology Institute for Hope and Innovation
Los Angeles, California, United States
Sacramento VA Medical Center - VA Northern California Health Care System
Mather, California, United States
Pacific Cancer Care
Monterey, California, United States
VA Palo Alto
Palo Alto, California, United States
Zuckerberg San Francisco General
San Francisco, California, United States
Kaiser Foundation Research Institute
San Francisco, California, United States
University of San Francisco
San Francisco, California, United States
San Francisco VA Medical Center
San Francisco, California, United States
Spark M. Matsunaga VA Medical Center
Honolulu, Hawaii, United States
North Las Vegas VA Medical Center
Las Vegas, Nevada, United States
George E. Wahlen Department of Veterans Affairs Medical Center
Salt Lake City, Utah, United States
Countries
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Central Contacts
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Facility Contacts
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Gabrielle Rocque, MD
Role: primary
Jennifer Y Pierce, MD
Role: primary
Finly Zachariah, MD
Role: primary
Sangeeta Aggarwal, MD
Role: primary
David Park, MD
Role: primary
Richy Agajanian, MD
Role: primary
Niharika Dixit, MD
Role: primary
Raymond Liu, MD
Role: primary
Kim Rhoads, MD
Role: primary
Other Identifiers
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63646
Identifier Type: -
Identifier Source: org_study_id
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