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 — BEHAVIORAL
    A 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 — OTHER
    Participants 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

Locations (1)

FacilityCityStateZIPSite coordinators
Stanford UniversityPalo AltoCalifornia94304
Yessica Mulet
650 725-7792
Aaron J Dawes, MD, PhD, FACS, FASCRS (PRINCIPAL_INVESTIGATOR)

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