A Community Health Worker Intervention to Improve Lung Cancer Screening Uptake in Community Health Centers
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Community health worker delivered outreach, shared decision-making, tobacco treatment, and navigation, Enhanced Usual Care.
- Who it may be relevant to
- Registry conditions: Lung Cancer, Tobacco Use. Basic parameters: 50 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Behavioral 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 - Other 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 measures
- Feasiblity [Time frame: once a month until study trial ends, an average one year]
- Fidelity [Time frame: once a month until study trial ends, an average of 1 year]
- Fidelity [Time frame: once a month until study trial ends, an average of 1 year]
- Fidelity [Time frame: once a month until study trial ends, an average of 1 year]
- Fidelity [Time frame: once a month until study trial ends, an average of 1 year]
- Acceptability [Time frame: 3 months post enrollment (for study participant) and through study completion, an average of 1 year (for CHW staff)]
Secondary outcome measures (5)
- LCS referral [Time frame: 3 months post study enrollment]
- LCS uptake [Time frame: Baseline and post intervention, 3 months post study enrollment]
- Tobacco Treatment receipt [Time frame: 3 months post study enrollment]
- Tobacco Treatment Duration [Time frame: 3 months post study enrollment]
- Tobacco Cessation [Time frame: 3 months post study enrollment]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Health services research
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07168629 · 2151088-4 · 1K08CA289097-01