Recruiting

APOYO

Sponsor:

Stanford University

Code:

NCT07403981

Conditions

Colorectal Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

CHW/P Navigator Support

Social Services Resource List

Study Details

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

Study ID

NCT07403981

Start date

Sep 1, 2026

Status verified date

Oct, 2026

Completion date

Jul 31, 2028

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. New diagnosis of colon or rectal cancer in the last 3 months
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 Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

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.

Interventions

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.

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.

Primary outcome measure

  • Quality of Life Score (EORTC QLQ-C30) [ Time Frame: Baseline to 6 months after randomization ]

Central Contacts and Locations

Central contacts

Study Coordinator

‪(408) 753-8976‬apoyo_team@stanford.edu

Locations

Stanford University

Recruiting

Palo Alto, California, United States, 94304

Contacts

Study Coordinator

408-753-8976apoyo_team@stanford.edu

Principal Investigator:

Aaron J Dawes, MD, PhD

More Information

Sponsor

Stanford University

Last update posted

Oct 6, 2026

Last verified

Oct, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-25. This information was provided to ClinicalTrials.gov by Stanford University on 2026-10-06. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.