Navigator Support for Colorectal Cancer

Overseen By Yessica Mulet

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Stanford University

Disqualifiers: Concurrent malignancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

Aaron J Dawes, MD, PhD, FACS, FASCRS

Principal Investigator

Stanford University

Are You a Good Fit for This Trial?

This trial is for newly diagnosed Latinx patients with colorectal cancer in Santa Clara County. It's designed to test if support from community health workers/promotoras and a list of social services can help improve their care.

Inclusion Criteria

Reside in and planning to receive care in Santa Clara County

Ability to understand and the willingness to provide written informed consent

I am 18 years old or older.

Exclusion Criteria

I cannot speak or understand Spanish or English.

I have no other cancers except for non-dangerous skin cancer or treated cervical cancer.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants in the intervention group receive support from a community health worker/patient navigator for up to 6 months

6 months

Regular contact every other week for the first 3 months, available by phone as needed for an additional 3 months

Follow-up

Participants are monitored for quality of life and healthcare utilization outcomes

6 months

What Are the Treatments Tested in This Trial?

Interventions

• CHW/P Navigator Support

Trial Overview

The study compares two approaches: one group receives support from community health workers/promotoras (CHW/P) navigators, while the other gets a list of social service resources. The goal is to see which method better improves quality of life and healthcare use.

How Is the Trial Designed?

Group I: Community Health Worker (CHW)/Patient Navigator (Intervention Group) Experimental Treatment 1 Intervention

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.

Group II: Usual Care plus Social Services Resource List (Control Group) Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+