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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
80
The CHW will perform: 1) patient outreach 2) patient-centered shared-decision making, 3) smoking cessation counseling, and 4) navigation of logistical barriers
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.
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
Time frame: 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
Time frame: 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.
Time frame: once a month until study trial ends, an average of 1 year
Fidelity
SDM aid use and resources utilized
Time frame: 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.
Time frame: 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.
Time frame: 3 months post enrollment (for study participant) and through study completion, an average of 1 year (for CHW staff)
LCS referral
Referral for LCS: Order either by CHW or PCP referring participant to LCS program.
Time frame: 3 months post study enrollment
LCS uptake
Receipt of LCS pre and post intervention
Time frame: Baseline and post intervention, 3 months post study enrollment
Tobacco Treatment receipt
Receipt of tobacco treatment: initiation and type of treatment
Time frame: 3 months post study enrollment
Tobacco Treatment Duration
Duration of tobacco treatment and cessation attempts.
Time frame: 3 months post study enrollment
Tobacco Cessation
Tobacco Cessation: # of quit attempts
Time frame: 3 months post study enrollment
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