Advocacy, Partnership, Outreach, and Yielding Optimized Care for Oncology Patients
Part of paid clinical trials in Palo Alto, California.
- Sponsor
- Stanford University
- Study ID
- NCT07403981
- Status
- Not Yet Recruiting
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Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- CHW/P Navigator Support — BEHAVIORALA Community Health Worker/Patient Navigator provides care coordination, social needs assessment, assistance accessing services, logistical support, and ongoing contact for up to 6 months following randomization.
- Social Services Resource List — OTHERParticipants receive a printed or digital list of local social service resources, including websites and phone numbers for enrollment and access to services.
Study Details
This study is a pilot feasibility randomized trial involving newly diagnosed colorectal cancer (CRC) patients who identify as Latinx. The study aims to leverage existing academic-community partnerships in Santa Clara County to develop and evaluate a multi-level community health worker/promotora (CHW/P) navigator intervention. If found effective, APOYO has the potential to affect clinical outcomes for Latinx colorectal cancer patients both directly and indirectly, including improving health-related quality of life, health care utilization, and reducing social needs.
Key Dates
- Start date
- Jul 31, 2026
- Status verified
- Jun 2026
- Primary completion
- Apr 30, 2027
- Completion
- Apr 30, 2027
Study Design
- Enrollment
- 60 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- SINGLE_GROUP
- Primary purpose
- SUPPORTIVE_CARE
Arms
- Experimental: Community Health Worker (CHW)/Patient Navigator (Intervention Group)Participants randomized to the intervention group will be assigned a CHW/P who will provide support for up to 6 months after randomization. CHW/Ps will attend the initial oncology visit when possible, review and explain the treatment plan, assist with scheduling and logistics (e.g., transportation, language services), complete a social needs assessment, connect patients to social support services, and offer peer support connections. CHW/Ps will maintain regular contact with patients, at least every other week for the first 3 months, and be available by phone as needed for an additional 3 months. They will also alert the clinical team if the patient expresses unresolved concerns or questions.
- Active Comparator: Usual Care plus Social Services Resource List (Control Group)Participants in the control group will receive a printed or digital list of local social service resources, including websites and phone numbers, but will not receive CHW/P support or navigation services.
Primary Outcome Measure
Quality of Life Score (EORTC QLQ-C30) [ Time Frame: Baseline to 6 months after randomization ]
Central Contacts
- Yessica Mulet650 725-7792
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Stanford University | Palo Alto | California | 94304 | Aaron J Dawes, MD, PhD, FACS, FASCRS (PRINCIPAL_INVESTIGATOR) |
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