Navigator Support for Colorectal Cancer

YM
Overseen ByYessica Mulet
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Stanford University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new support program for Latinx individuals recently diagnosed with colorectal cancer. The researchers aim to determine if a community health worker (CHW) or patient navigator can enhance the healthcare experience by providing support such as attending medical visits, arranging transportation, and connecting participants to social services. Participants will be randomly assigned to either a group receiving this additional support or a group receiving a list of social services. Ideal candidates are those diagnosed with colon or rectal cancer in the last 30 days who plan to receive treatment in Santa Clara County. As an unphased trial, this study offers a unique opportunity to improve healthcare experiences through personalized support.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the CHW/P Navigator Support is safe for colorectal cancer patients?

Research has shown that using Community Health Workers (CHWs) and Patient Navigators is both safe and beneficial. Studies have found that these programs expedite and enhance cancer screenings, such as for colorectal cancer. This indicates successful past use without safety issues.

CHWs and navigators assist patients by explaining treatment plans, scheduling appointments, and connecting them to social support services. They also regularly check in with patients. No evidence suggests these activities cause harm, so they are considered safe. Overall, these support systems effectively aid patients without negative effects.12345

Why are researchers excited about this trial?

Researchers are excited about Navigator Support for Colorectal Cancer because it offers a personalized, hands-on approach that’s different from standard care. While usual care might involve receiving a list of social services, this method assigns a Community Health Worker/Patient Navigator to each participant. These navigators don’t just explain treatment plans but also help with scheduling, transportation, and connecting patients with social support services, maintaining regular contact for up to six months. This approach aims to address both medical and social needs, potentially improving patient experiences and outcomes in ways that traditional treatments alone might not achieve.

What evidence suggests that the CHW/P Navigator Support is effective for colorectal cancer patients?

Research has shown that programs with community health workers (CHWs) and patient navigators help more people complete cancer screenings, such as those for colorectal cancer, on time. In this trial, participants in the intervention group will receive support from a CHW or patient navigator. One study found that these programs improve cancer care by connecting patients with necessary resources and support. They also prove cost-effective, especially for individuals with low incomes or no insurance, by making cancer screenings more accessible. By reducing health disparities among groups, CHW programs can enhance health outcomes for colorectal cancer patients. This support can lead to better disease management and may improve quality of life.12467

Who Is on the Research Team?

AJ

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.
See 2 more

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?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Community Health Worker (CHW)/Patient Navigator (Intervention Group)Experimental Treatment1 Intervention
Group II: Usual Care plus Social Services Resource List (Control Group)Active Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials
2,527
Recruited
17,430,000+

Citations

Use of Community Health Workers and Patient Navigators to ...

Our findings support the effectiveness of CHW/PN programs to improve completion and timeliness of breast, cervical, and colorectal cancer screening in FQHCs.

Examining the Cost-Effectiveness of Introducing Patient ...

This study looked at whether community health workers (CHWs) helping uninsured, low-income adults get screened for colorectal cancer is cost-effective. Using ...

Engaging Community Health Workers to Increase Cancer ...

Use of community health workers and patient navigators to improve cancer outcomes among patients served by federally qualified health centers: a systematic ...

An Exploration of Patient Navigation and Community Health ...

Patient navigation (PN) and community health worker (CHW) interventions have been demonstrated to reduce health disparities by addressing the ...

Engaging Community Health Workers to Increase Cancer ...

For colorectal cancer screening, 2 U.S. studies reported both a negative incremental cost and an increase in quality-adjusted life years saved with colonoscopy ...

Cancer Screening: Interventions Engaging ...

Cancer Screening: Interventions Engaging Community Health Workers—Colorectal Cancer ... o PN: patient navigator o RCT: randomized control trial. Page 2 ...

The Role of CHWs in Combatting Colorectal Cancer

Use of a patient navigator to increase colorectal cancer screening in an urban neighborhood health clinic. J Urban Health. 2005;82(2):216-224. http://www.