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.
Lung cancer is a leading cause of cancer death, and lung cancer screening (LCS) with low-dose computed tomography can reduce lung cancer-related mortality among eligible individuals. However, uptake of LCS remains low, particularly among populations that face barriers to accessing preventive care. Community health worker (CHW) interventions have been effective at promoting screening and reducing barriers to care in other cancer settings. This study was designed to develop and pilot test a multi-component intervention intended to improve LCS uptake and tobacco treatment utilization. The intervention includes four components: 1) patient outreach, 2) patient-centered shared decision-making about lung cancer screening, 3) tobacco treatment counseling for participants who currently smoke, and 4) navigation of logistical barriers to care. The intervention was developed in partnership with a community advisory board composed of community stakeholders and individuals with lived experience, using principles from the Transcreation Framework for Community-Engaged Behavioral Interventions. The pilot randomized controlled trial is being conducted within Baystate Health community health centers. Participants are randomized to one of three study arms: 1) enhanced usual care, which includes mailed lung cancer screening educational materials and usual screening care through the participant's primary care provider; 2) the multi-component intervention delivered by a community health worker; or 3) the same multi-component intervention delivered by a trained lay navigator, such as a research assistant or pre-medical student. The study will evaluate the feasibility of implementing the intervention using different navigator models. Primary pilot outcomes include participant recruitment, measure completion, retention, intervention fidelity, and acceptability. Secondary outcomes include lung cancer screening and tobacco treatment utilization. The study will also explore potential mechanisms through which the intervention may influence screening, including knowledge about lung cancer screening and assistance overcoming logistical barriers to care. Findings from this pilot study will inform the design of a future, fully powered randomized controlled trial evaluating approaches to improving access to lung cancer screening and tobacco treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
120
The CHW will perform: 1) patient outreach 2) patient-centered shared-decision making, 3) tobacco treatmnet counseling, and 4) navigation of logistical barriers
The lay navigator will perform: 1) patient outreach 2) patient-centered shared-decision making, 3) tobacco treatment counseling, and 4) navigation of logistical barriers
Participants will receive educational materials about lung cancer screening and usual lung cancer screening care through their primary care provider.
Baystate Health
Springfield, Massachusetts, United States
RECRUITINGFeasibility: Number of participants at each stage of the recruitment and retention cascade
Counts abstracted from the study screening and enrollment log at each of the following stages: approached, screened eligible, consented, randomized, completed baseline data collection, and completed post-intervention follow-up assessment.
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
Percentages calculated from the study screening and enrollment log. Eligibility rate = number screened eligible divided by number approached. Consent rate = number consented divided by number screened eligible. Randomization rate = number randomized divided by number consented. Baseline completion rate = number completing baseline data collection divided by number randomized. Retention rate = number completing post-intervention follow-up divided by number randomized.
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 in minutes spent on SDM, recorded by community health workers (CHWs) and lay navigators in the encounter/call tracking log.
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 in minutes spent on smoking cessation counseling,recorded by community health workers (CHWs) and lay navigators in the encounter/call tracking log.
Time frame: once a month until study trial ends, an average of 1 year
Fidelity - SDM quality using OPTION Scale Observer OPTION Scale
Mean total score on the OPTION Scale Observer OPTION Scale scored from audio-recorded SDM encounters; 12 items rated 0 ("not observed") to 4 ("exhibited at a very high standard"), total score 0-48, with higher scores indicating greater SDM competence.
Time frame: once a month until study trial ends, an average of 1 year
Fidelity - Completion of SDM required elements
Mean count of CMS SDM Elements completed during each encounter: reduced lung cancer mortality, false positive, overdiagnosis, radiation exposure, annual screening, smoking cessation, follow-up testing, and diagnostic procedures.
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
Proportion of participants for whom the SDM decision aid was used, documented in the CHW and lay navigator encounter log.
Time frame: Monthly through study completion, an average of 1 year
Fidelity: Percentage of participants referred to tobacco treatment services, by type
Proportion referred to any tobacco treatment service by type (telephone quitline, in-person counseling,), from EHR referral orders and the CHW and lay navigator encounter log.
Time frame: Monthly through study completion, an average of 1 year
Acceptability of the CHW and lay navigator intervention to participants
Qualitative themes regarding overall experience with the CHW and lay navigator intervention and barriers to lung cancer screening, identified through thematic analyses of semi-structured interviews using a study-specific interview guide. Participants (N=15), \~40-45 minutes, conducted in private at 3-month follow-up;
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
Qualitative themes regarding overall experience with the Naviagtor intervention and barriers to lung cancer screening, identified through thematic analysis of Navigator encounter logs and semi-structured interviews using a study-specific interview guide. Navigators (N=3), one 45-minute interview each after final intervention delivery.
Time frame: 3 months post-enrollment (participants) and through study completion, an average of 1 year (navigators)
Percentage of participants with a lung cancer screening (LCS) referral order
Proportion of participants with an order placed in the electronic health record referring them to the LCS program, abstracted from EHR order data. Reported overall and by ordering source (community health worker vs. primary care provider).
Time frame: 3 months post study enrollment
Percentage of participants completing low-dose CT lung cancer screening (LCS uptake)
Proportion of participants with a completed low-dose CT scan documented in the electronic health record, ascertained by EHR chart abstraction
Time frame: Baseline and post intervention, 3 months post study enrollment
Percentage of participants initiating tobacco treatment, by treatment type
Proportion of participants initiating any tobacco treatment, and proportion by type (telephone quitline, in-person counseling, nicotine replacement therapy, prescription pharmacotherapy), ascertained by EHR chart abstraction and participant self-report at follow-up.
Time frame: 3 months post study enrollment
Duration in weeks of tobacco treatment
Number of weeks of continuous tobacco treatment received, calculated from EHR pharmacy fill and counseling encounter data supplemented by participant self-report.
Time frame: 3 months post study enrollment
Number of self-reported quit attempts per participant
Count of quit attempts lasting at least 24 hours, measured by participant self-report at the 3-month follow-up assessment.
Time frame: 3 months post study enrollment
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