Comparative Effectiveness Trial of Two Supportive Cancer Care Delivery Models for Adults With Cancer
1 other identifier
interventional
2,996
1 country
17
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2022
Longer than P75 for not_applicable
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 17, 2022
CompletedFirst Posted
Study publicly available on registry
March 28, 2022
CompletedStudy Start
First participant enrolled
June 24, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 28, 2028
April 30, 2026
April 1, 2026
5.6 years
March 17, 2022
April 24, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (10)
Change in health-related quality of life as assessed by the Functional Assessment of Cancer Therapy (FACT-G).
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).
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.
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)
Change in satisfaction with decision from baseline to 3, 6, and 12 months
Palliative Care Use (Self-reported and Chart Review)
3, 6, and 12 months after patient enrollment
- +5 more secondary outcomes
Other Outcomes (2)
Time Toxicity
3, 6, and 12 months after patient enrollment
Financial Toxicity
3, 6, and 12 months after patient enrollment
Study Arms (2)
Technology-based supportive cancer care
ACTIVE COMPARATORPatients 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
EXPERIMENTALPatients 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Newly diagnosed patients with solid tumor cancer diagnosis or recurrence of the disease.
- Patients must have the ability to understand and willingness to provide verbal consent.
- Participants must speak English, Spanish, Chinese, or Vietnamese.
You may not qualify if:
- Inability to consent to the study
- Plans to change oncologist within 12 months
- Employed by the practice site
- Patients who anticipate moving from the area within 12 months
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Stanford Universitylead
- Patient-Centered Outcomes Research Institutecollaborator
Study Sites (17)
University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
University of South Alabama
Mobile, Alabama, 36688, United States
Beckman Research Institute of City of Hope
Duarte, California, 91010, United States
VA Medical Center, Fresno
Fresno, California, 93703, United States
Santa Clara Valley Medical Center
Fruitdale, California, 95128, United States
St Jude Heritage Medical Group
Fullerton, California, 92835, United States
Oncology Institute for Hope and Innovation
Los Angeles, California, 90017, United States
Sacramento VA Medical Center - VA Northern California Health Care System
Mather, California, 95655, United States
Pacific Cancer Care
Monterey, California, 93940, United States
VA Palo Alto
Palo Alto, California, 94305, United States
Zuckerberg San Francisco General
San Francisco, California, 94110, United States
Kaiser Foundation Research Institute
San Francisco, California, 94115, United States
University of San Francisco
San Francisco, California, 94117, United States
San Francisco VA Medical Center
San Francisco, California, 94121, United States
Spark M. Matsunaga VA Medical Center
Honolulu, Hawaii, 96819, United States
North Las Vegas VA Medical Center
Las Vegas, Nevada, 89086, United States
George E. Wahlen Department of Veterans Affairs Medical Center
Salt Lake City, Utah, 84148, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor of Medicine
Study Record Dates
First Submitted
March 17, 2022
First Posted
March 28, 2022
Study Start
June 24, 2022
Primary Completion (Estimated)
January 31, 2028
Study Completion (Estimated)
February 28, 2028
Last Updated
April 30, 2026
Record last verified: 2026-04