RecruitingRecruiting
Comparative Effectiveness Trial of Two Supportive Cancer Care Delivery Models for Adults With Cancer
NCT05297734 · Stanford University
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
About this study
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.
Eligibility criteria
Inclusion Criteria:
1. Newly diagnosed patients with solid tumor cancer diagnosis or recurrence of the disease.
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:
1. Inability to consent to the study
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
Study design
Enrollment target: 2996 participants
Allocation: randomized
Masking: single
Age groups: adult, older_adult
Timeline
Starts: 2022-06-24
Estimated completion: 2028-02-28
Last updated: 2026-04-30
Interventions
Other: Receive technology-based supportive cancer careBehavioral: Receive redesigned team-based supportive cancer care
Primary outcomes
- • 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 3 months)
Sponsor
Stanford University · other
With: Patient-Centered Outcomes Research Institute
Contacts & investigators
ContactManali I Patel, MD MPH MS · contact · manalip@stanford.edu · 6507234000
All locations (17)
University of Alabama at BirminghamRecruiting
Birmingham, Alabama, United States
University of South AlabamaRecruiting
Mobile, Alabama, United States
Beckman Research Institute of City of HopeRecruiting
Duarte, California, United States
VA Medical Center, FresnoRecruiting
Fresno, California, United States
Santa Clara Valley Medical CenterRecruiting
Fruitdale, California, United States
St Jude Heritage Medical GroupRecruiting
Fullerton, California, United States
Oncology Institute for Hope and InnovationRecruiting
Los Angeles, California, United States
Sacramento VA Medical Center - VA Northern California Health Care SystemActive Not Recruiting
Mather, California, United States
Pacific Cancer CareActive Not Recruiting
Monterey, California, United States
VA Palo AltoActive Not Recruiting
Palo Alto, California, United States
Zuckerberg San Francisco GeneralRecruiting
San Francisco, California, United States
Kaiser Foundation Research InstituteRecruiting
San Francisco, California, United States
University of San FranciscoRecruiting
San Francisco, California, United States
San Francisco VA Medical CenterActive Not Recruiting
San Francisco, California, United States
Spark M. Matsunaga VA Medical CenterRecruiting
Honolulu, Hawaii, United States
North Las Vegas VA Medical CenterActive Not Recruiting
Las Vegas, Nevada, United States
George E. Wahlen Department of Veterans Affairs Medical CenterRecruiting
Salt Lake City, Utah, United States