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NCT Number: NCT07403981

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford University

Palo Alto, California, 94304, United States

Location contact

Aaron J Dawes, MD, PhD, FACS, FASCRS

PRINCIPAL_INVESTIGATOR

Yessica Mulet

CONTACT

[email protected]

650 725-7792

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

Primary outcomes

  1. Quality of Life Score (EORTC QLQ-C30)

    Time frame: Baseline to 6 months after randomization

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Yessica Mulet

CONTACT

[email protected]

650 725-7792

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Feb 11, 2026
Registry last updated
Jun 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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