A Community Health Worker Intervention to Improve Lung Cancer Screening Uptake in Community Health Centers

NCT ID: NCT07168629

Last Updated: 2025-09-11

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-01
• Study Completion Date: 2028-08-01

Brief Summary

Lung cancer screening (LCS) can reduce lung cancer-related mortality by 20%, but only 5-10% of eligible individuals have received an initial LCS. The goal of this study is to partner with community stakeholders to jointly develop and pilot test a multi-component community health worker-delivered intervention targeting key barriers to improve LCS and tobacco treatment utilization. The proposed activities will lay the groundwork for a subsequent R01 grant, conducting a fully powered randomized clinical trial to establish CHWs as an evidence-based practice that will facilitate access to screening and tobacco treatment, to reduce lung cancer mortality.

Detailed Description

Lung cancer is the leading cause of cancer death, and lung cancer screening (LCS) can reduce lung cancer-related mortality by 20%. However, only 5-10% of eligible individuals have received an initial LCS exam. Community health worker (CHW) interventions have been effective at promoting screening in other cancer settings. Whether a CHW-delivered intervention can be effective in the context of LCS and address key barriers to receiving LCS remains unknown. The goal of this study is to develop and pilot test a four-part CHW-delivered intervention to improve LCS uptake, which includes: 1) patient outreach, 2) patient-centered shared decision-making, 3) smoking cessation counseling, and 4) navigation of logistical barriers. Our central hypothesis, based on our qualitative work and informed by the expanded Health Belief Model, proposes that a CHW-delivered intervention can address key modifiable factors to improve LCS awareness, engagement, and barriers to accessing care, leading to increased LCS uptake. Our aims are to: Jointly "transcreate" a CHW-delivered intervention to increase LCS uptake among patients served by community health centers (Aim 1); conduct a pilot randomized controlled trial of the intervention (Aim 2a); and obtain empiric estimates of effect size in LCS and tobacco treatment utilization (Aim 2b). We first seek to jointly "transcreate" the intervention with our community advisory board, comprised of key stakeholders in LCS and patients with lived experience, applying the Transcreation Framework for Community-Engaged Behavioral Interventions. Then we will conduct a pilot randomized controlled trial of the CHW-delivered intervention at Baystate Health's three community health centers. We will randomize 80 LCS-eligible individuals (40 in each arm) to either the intervention or enhanced usual care (i.e., mailed LCS educational materials and usual LCS as per primary care provider). Primary pilot outcomes are focused on feasibility, including participant recruitment, measure completion, retention, fidelity, and acceptability. We will also conduct an evaluation of secondary trial outcomes, including LCS and tobacco treatment utilization, as well as explore potential mediators (e.g., knowledge, facilitation of logistical barriers). The proposed activities will provide me with crucial skills in community-engaged research, implementation science, and clinical trial design, and launch my career as a clinician-scientist dedicated to addressing lung cancer mortality. This work will also lay the groundwork for a subsequent R01 grant conducting a fully powered randomized controlled trial of the CHW-delivered intervention that directly addresses top priorities from the President's Cancer Moonshot and NCI's mission to develop multi-level interventions that facilitate access to cancer screening and reduce lung cancer mortality.

Conditions

Lung Cancer; Tobacco Use

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Enhanced Usual Care

Will receive educational materials about lung cancer screening and tobacco treatment.

Group Type: ACTIVE_COMPARATOR

Enhanced Usual Care

Intervention Type: OTHER

After randomization, the control group will receive the same mailed LCS educational materials as the intervention group and encouraged to discuss screening with their PCP, the typical pathway through which patients enter the LCS program.

Intervention

Will receive a four-part community health worker-delivered intervention to improve LCS uptake, which includes: 1) patient outreach, 2) patient-centered shared decision-making, 3) smoking cessation counseling, and 4) navigation of logistical barriers

Group Type: EXPERIMENTAL

Community health worker delivered outreach, shared decision-making, tobacco treatment, and navigation

Intervention Type: BEHAVIORAL

The CHW will perform: 1) patient outreach 2) patient-centered shared-decision making, 3) smoking cessation counseling, and 4) navigation of logistical barriers

Interventions

Community health worker delivered outreach, shared decision-making, tobacco treatment, and navigation

The CHW will perform: 1) patient outreach 2) patient-centered shared-decision making, 3) smoking cessation counseling, and 4) navigation of logistical barriers

Intervention Type: BEHAVIORAL

Enhanced Usual Care

After randomization, the control group will receive the same mailed LCS educational materials as the intervention group and encouraged to discuss screening with their PCP, the typical pathway through which patients enter the LCS program.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Adults between the age of 50 and 80.
• Potentially eligible for LCS according to the Electronic Health Record smoking history.
• Receive their primary care at Mason Square, High Street, or Brightwood community health centers.
• English- or Spanish- speaking.

Exclusion Criteria

• Not eligible for lung cancer screening based on age (age < 50 or > 80 years) or smoking history (has not smoked more than 20 pack-years of tobacco cigarettes or quit more than 15 years ago).
• Have received a lung cancer screen in the past.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Baystate Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Eduardo

Assistant Professor Departments of Medicine and Healthcare Delivery and Population Sciences

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jennifer Pacheco

Role: STUDY_DIRECTOR

Baystate Health

Central Contacts

Eduardo R Nunez, MD, MS

Role: CONTACT

Eduardo.nunez2@baystatehealth.org

1-855-794-5864

Chisom Unegbu, BS

Role: CONTACT

CHISOM.UNEGBU@baystatehealth.org

Other Identifiers

1K08CA289097-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2151088-4

Identifier Type: -

Identifier Source: org_study_id