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

NCT07168629 | Not Yet Recruiting

• 2 other identifiers: 2151088-41K08CA289097-01
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Lung Cancer; Tobacco Use

Keywords

lung cancer screening; tobacco treatment; community health workers; community health centers

Outcome Measures

Primary Outcomes (6)

• Feasiblity

  Recruitment \& enrollment: # of participants approached, met eligibility, and randomized Baseline Measures (see Table 5): Completeness of data collection. Retention: Loss of follow-up, reason for discontinuation, completeness of post-intervention data

  once a month until study trial ends, an average one year

• Fidelity

  Duration of SDM and Smoking cessation Navigation: amount of time spent per call

  once a month until study trial ends, an average of 1 year

• Fidelity

  Completion of SDM and Smoking Cessation SDM OPTION Scale: measures 12 SDM items on a 5-point scale with response values ranging from "not observed" (value of 0) to "exhibited at a very high standard" (value of 4), with a total possible score ranging from 0 to 48. CMS SDM elements: reduced lung cancer mortality, false positive, overdiagnosis, radiation exposure, annual screening, smoking cessation, follow-up testing, and diagnostic procedures.

  once a month until study trial ends, an average of 1 year

• Fidelity

  SDM aid use and resources utilized

  once a month until study trial ends, an average of 1 year

• Fidelity

  Referral to tobacco treatment services and type of referral (e.g., telephone quit line, in-person), nicotine replacement therapy.

  once a month until study trial ends, an average of 1 year

• Acceptability

  CHWs: Encounter logs documenting participant concerns and barriers to LCS Qualitative Interviews: Participants (N=15): Completed at the 3-month follow-up in a private setting, duration \~40-45 minutes, to assess the overall experience with the CHW intervention and barriers to LCS. CHWs (N=3): One 45-minute interview with each CHW after completing their last intervention delivery during the trial period.

  3 months post enrollment (for study participant) and through study completion, an average of 1 year (for CHW staff)

Secondary Outcomes (5)

• LCS referral

  3 months post study enrollment

• LCS uptake

  Baseline and post intervention, 3 months post study enrollment

• Tobacco Treatment receipt

  3 months post study enrollment

• Tobacco Treatment Duration

  3 months post study enrollment

• Tobacco Cessation

  3 months post study enrollment

Other Outcomes (4)

• LCS knowledge

  Baseline and at 3 months post-enrollment

• LCS beliefs and barriers

  At baseline and at 3 months post-enrollment

• Trust in Navigator

  3 months post-enrollment

Study Arms (2)

Enhanced Usual Care

ACTIVE COMPARATOR

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

Other: Enhanced Usual Care

Intervention

EXPERIMENTAL

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

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

Interventions

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

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

Intervention

Enhanced Usual Care 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.

Enhanced Usual Care

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Baystate Medical Center: lead
• National Cancer Institute (NCI): collaborator

MeSH Terms

Conditions

Lung Neoplasms; Tobacco Use

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Behavior

Study Officials

• Jennifer Pacheco

  Baystate Health

  STUDY DIRECTOR

Central Study Contacts

Eduardo R Nunez, MD, MS

CONTACT

1-855-794-5864; Eduardo.nunez2@baystatehealth.org

Chisom Unegbu, BS

CONTACT

CHISOM.UNEGBU@baystatehealth.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor Departments of Medicine and Healthcare Delivery and Population Sciences

Model Details: Randomized Control Trial

Study Record Dates

• First Submitted: August 13, 2025
• First Posted: September 11, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): August 1, 2028
• Last Updated: September 11, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share