Recruiting

Community Health Workers

Sponsor:

Baystate Medical Center

Code:

NCT07168629

Conditions

Lung Cancer

Tobacco Use

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Accepted

Interventions

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

Enhanced Usual Care

Study Details

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

Study ID

NCT07168629

Start date

May 10, 2026

Status verified date

Aug, 2026

Completion date

Aug 1, 2028

Anticipated

Primary completion date

Feb 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

active comparator: Enhanced Usual Care

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

experimental: 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

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

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.

Primary outcome measure

  • Feasibility: Number of participants at each stage of the recruitment and retention cascade [ Time Frame: once a month until study trial ends, an average one year ]
  • Feasibility: Percentage of participants at each stage of the recruitment and retention cascade [ Time Frame: once a month until study trial ends, an average one year ]
  • Fidelity: Duration in minutes of shared decision making (SDM) counseling per encounter [ Time Frame: once a month until study trial ends, an average of 1 year ]
  • Fidelity: Duration in minutes of smoking cessation counseling per encounter [ Time Frame: once a month until study trial ends, an average of 1 year ]
  • Fidelity - SDM quality using OPTION Scale Observer OPTION Scale [ Time Frame: once a month until study trial ends, an average of 1 year ]
  • Fidelity - Completion of SDM required elements [ Time Frame: once a month until study trial ends, an average of 1 year ]
  • Fidelity: Percentage of participants with documented use of the SDM decision aid [ Time Frame: Monthly through study completion, an average of 1 year ]
  • Fidelity: Percentage of participants referred to tobacco treatment services, by type [ Time Frame: Monthly through study completion, an average of 1 year ]
  • Acceptability of the CHW intervention to participants [ Time Frame: 3 months post-enrollment (participants) and through study completion, an average of 1 year (CHWs) ]
  • Acceptability of the CHW intervention to CHWs [ Time Frame: 3 months post-enrollment (participants) and through study completion, an average of 1 year (CHWs) ]

Central Contacts and Locations

Central contacts

Eduardo R Nunez, MD, MS

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

Chisom Unegbu, BS

CHISOM.UNEGBU@baystatehealth.org

Locations

Baystate Health

Recruiting

Springfield, Massachusetts, United States, 01107

More Information

Sponsor

Baystate Medical Center

Last update posted

Aug 21, 2026

Last verified

Aug, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Baystate Medical Center on 2026-08-21.