Advocacy, Partnership, Outreach, and Yielding Optimized Care for Oncology Patients

Advocacy, Partnership, Outreach, and Yielding Optimized Care for Oncology Patients (APOYO): A Community Health Worker Intervention for Latinx Colorectal Cancer Patients

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Colorectal Cancer
• Intervention / Treatment: Behavioral: CHW/P Navigator Support; Other: Social Services Resource List

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yessica Mulet; Phone Number: 650 725-7792; Email: yessicam@stanford.edu

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94304
      • Stanford University
      • Principal Investigator: Aaron J Dawes, MD, PhD, FACS, FASCRS
      • Contact: Yessica Mulet; Phone Number: 650 725-7792; Email: yessicam@stanford.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. New diagnosis of colon or rectal cancer in the last 30 days
2. Identify as Latinx/Hispanic/Latino
3. Aged 18 years or older
4. Reside in and planning to receive care in Santa Clara County
5. Ability to understand and the willingness to provide written informed consent

Exclusion Criteria:

1. Unable to speak and understand either Spanish or English
2. Any concurrent malignancy other than nonmelanoma skin cancer or carcinoma in situ of the cervix. Patients with any previous malignancy without evidence of disease for >3 years will be allowed to enter the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Behavioral: CHW/P Navigator Support; 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.
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.	Other: Social Services Resource List; Participants receive a printed or digital list of local social service resources, including websites and phone numbers for enrollment and access to services.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Life Score (EORTC QLQ-C30)	Quality of life will be measured using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ-C30), comparing participants randomized to CHW/P navigator support versus usual care with a social services resource list. Scores are linearly transformed to a 0-100 scale, with higher scores indicating better overall quality of life and functioning.	Baseline to 6 months after randomization

Collaborators and Investigators

• Sponsor: Stanford University
• Investigators: Principal Investigator: Aaron J Dawes, MD, PhD, FACS, FASCRS, Stanford University

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027

Study Registration Dates

• First Submitted: February 4, 2026
• First Submitted That Met QC Criteria: February 4, 2026
• First Posted (Actual): February 11, 2026

Study Record Updates

• Last Update Posted (Actual): June 4, 2026
• Last Update Submitted That Met QC Criteria: June 2, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colonic Diseases; Colorectal Neoplasms
• Other Study ID Numbers: IRB-82643

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No