Community Health Workers and Precision Medicine

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-03

Study Completion Date

2023-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this randomized controlled trial is to evaluate whether a trained community health worker (CHW) who engages with newly diagnosed patients after a diagnosis of cancer can effectively improve knowledge and receipt of evidence-based precision medicine cancer care services among low-income and minority patients.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

COVID-19 Testing in Underserved and Vulnerable Populations

NCT05315908

Heart Failure Coronary Artery Disease Cancer +5 more

TERMINATED NA

Increasing Implementation of Evidence-based Interventions at Low-wage Worksites

NCT02005497

Cancer Health Promotion

COMPLETED NA

A Community Health Education Intervention for Increasing Community-driven Actions to Reduce the Cancer Burden in Western New York

NCT06681077

Healthy

RECRUITING NA

Advance Care Planning for Older Latinos With Chronic Illness

NCT06081660

Patient Engagement End of Life Chronic Disease +1 more

COMPLETED NA

A Multi-center Trial of IMPaCT CHW Support for Chronically-ill Patients

NCT02347787

Hypertension Diabetes Obesity +1 more

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The goal of this study is to reduce cancer disparities by improving the knowledge and delivery of evidence-based precision medicine for cancer care. We plan to randomize newly diagnosed patients and those currently under cancer care to either a control arm (usual cancer care alone) versus an intervention arm (layered on top of usual cancer care alone) where patients are assigned to a community health worker who will assist patients in ensuring the following discussions with their care team: 1) precision cancer care 2) cancer diagnosis and treatment plan 2) adherence to treatments and 3) goals of care and symptom burden. A total of 55 participants per study group (total 110) will be recruited in Monterey County from Pacific Cancer Care.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cancer Tumor

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This will be a parallel two-arm randomized controlled trial with the following two arms: (1) usual oncology care or (2) usual oncology care + supplemental community health worker intervention. All participants who consent to the study will be randomized 1:1 into the usual oncology care arm versus the intervention arm. Patients randomized into the intervention arm will be assigned a community health worker who will begin the intervention. Each arm will include 55 participants (total for the study n=110).

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Usual Oncology Care

This arm is the control group. They will receive usual oncology care from their regular oncologist and care team with no change in their care plan or treatment as a result of the intervention. Outcomes will be assessed at each of the following times: baseline, 3-months, 6-months, and 12-months.

Group Type NO_INTERVENTION

No interventions assigned to this group

Community Health Worker Intervention

This arm is the treatment group. Patients randomized into the intervention will be assigned a community health worker who will contact the patient to begin the intervention. They will receive usual oncology care from their regular oncologist and care team but will also receive supplemental support and health education from a community health worker. The lay health worker will assist patients in ensuring that patients discuss the following with their cancer care teams: 1) precision medicine 2) cancer diagnosis and treatment plan 3) adherence to treatments and 3) goals of care and 4) symptom burden. Outcomes will be assessed at each of the following times: baseline, 3-months, 6-months, and 12-months.

Group Type EXPERIMENTAL

Community Health Worker Support

Intervention Type BEHAVIORAL

For those in the experimental group, a community health worker will provide health education and support as described in the Community Health Worker Intervention arm.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Community Health Worker Support

For those in the experimental group, a community health worker will provide health education and support as described in the Community Health Worker Intervention arm.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Newly diagnosed patients with a cancer diagnosis.
* Patients with any relapse or progressive disease (any cancer diagnosis) as identified by imaging or biopsy and confirmed by a physician.
* The patients must be 18 years or older.
* Patients must have the capacity to verbally consent in English or Spanish.
* Patients must be racial/ethnic minorities OR low-income status OR public insurance (Medi-Cal or other) OR have health insurance provided by an agricultural company OR be uninsured

Exclusion Criteria

* Patients under 18 years of age.
* Inability to consent to the study due to lack of capacity as documented by the referring physician.
* Patients without a newly diagnosed malignancy or patients without relapse of disease.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No