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

NCT07403981 | Not Yet Recruiting

• 1 other identifier: IRB-82643
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Community Health Worker (CHW)/Patient Navigator (Intervention Group)

EXPERIMENTAL

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

Usual Care plus Social Services Resource List (Control Group)

ACTIVE COMPARATOR

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

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.

Community Health Worker (CHW)/Patient Navigator (Intervention Group)

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.

Usual Care plus Social Services Resource List (Control Group)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Unable to speak and understand either Spanish or English
• 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

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University

Palo Alto, California, 94304, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Aaron J Dawes, MD, PhD, FACS, FASCRS

  Stanford University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yessica Mulet

CONTACT

650 725-7792; yessicam@stanford.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2026
• First Posted: February 11, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: February 13, 2026

Record last verified: 2026-02

Locations

US (1)