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

Lay Navigator 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, but screening uptake remains low among eligible individuals. The goal of this study is to partner with community stakeholders to develop and pilot test a multi-component navigator-delivered intervention targeting key barriers to lung cancer screening and tobacco treatment utilization. Participants are randomized to enhanced usual care, a community health worker (CHW)-delivered intervention, or the same intervention delivered by a trained lay navigator. The intervention includes patient outreach, patient-centered shared decision-making, tobacco treatment counseling, and assistance navigating logistical barriers to care. The proposed activities will lay the groundwork for a subsequent fully powered randomized clinical trial evaluating CHW- and lay navigator-delivered approaches to facilitate access to lung cancer screening and tobacco treatment.

Conditions

Lung Cancer

Tobacco Use

Study ID

NCT07168629

Start date

May 10, 2026

Status verified date

Sep, 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

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

active comparator: Enhanced Usual Care

Partcipants will receive educational materials about lung cancer screening

experimental: Community Health Worker-delivered Intervention

Participants will receive a four-part intervention delivered by a community health worker to improve lung cancer screening uptake. The intervention includes: 1) patient outreach, 2) patient-centered shared decision-making, 3) tobacco treatment counseling, and 4) navigation of logistical barriers to care.

experimental: Lay Navigator-delivered Intervention

Participants will receive the same four-part intervention delivered by a trained lay navigator to improve lung cancer screening uptake. The intervention includes: 1) patient outreach, 2) patient-centered shared decision-making, 3) tobacco treatment counseling, and 4) navigation of logistical barriers to care.

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) tobacco treatmnet counseling, and 4) navigation of logistical barriers

Lay Navigator delivered outreach, shared decision-making, tobacco treatment, and navigation

The lay navigator will perform: 1) patient outreach 2) patient-centered shared-decision making, 3) tobacco treatment counseling, and 4) navigation of logistical barriers

Enhanced Usual Care

Participants will receive educational materials about lung cancer screening and usual lung cancer screening care through their primary care provider.

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 and lay navigator intervention to participants [ Time Frame: 3 months post-enrollment (participants) and through study completion, an average of 1 year (navigators) ]
  • Acceptability of the intervention to CHWs and Lay navigators [ Time Frame: 3 months post-enrollment (participants) and through study completion, an average of 1 year (navigators) ]

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

Sep 22, 2026

Last verified

Sep, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-25. This information was provided to ClinicalTrials.gov by Baystate Medical Center on 2026-09-22. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.