Baystate Health
Springfield, Massachusetts, 01107, United States
Location status: Recruiting
NCT Number: NCT07168629
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.
Interested in participating?
Request Info50 year–80 year
All sexes
Interventional
Not applicable
Springfield, Massachusetts, 01107, United States
Location status: Recruiting
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: once a month until study trial ends, an average one year
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
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 of 1 year
Time in minutes spent on SDM, recorded by community health workers (CHWs) in the encounter/call tracking log.
Time frame: once a month until study trial ends, an average of 1 year
Time in minutes spent on smoking cessation counseling,recorded by community health workers (CHWs) in the encounter/call tracking log.
Time frame: once a month until study trial ends, an average of 1 year
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
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: Monthly through study completion, an average of 1 year
Proportion of participants for whom the SDM decision aid was used, documented in the CHW encounter log.
Time frame: Monthly through study completion, an average of 1 year
Proportion referred to any tobacco treatment service by type (telephone quitline, in-person counseling,), from EHR referral orders and the CHW encounter log.
Time frame: 3 months post-enrollment (participants) and through study completion, an average of 1 year (CHWs)
Qualitative themes regarding overall experience with the CHW 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 (CHWs)
Qualitative themes regarding overall experience with the CHW intervention and barriers to lung cancer screening, identified through thematic analysis of CHW encounter logs and semi-structured interviews using a study-specific interview guide. CHWs (N=3), one 45-minute interview each after final intervention delivery.
Time frame: 3 months post study enrollment
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: Baseline and post intervention, 3 months post study enrollment
Proportion of participants with a completed low-dose CT scan documented in the electronic health record, ascertained by EHR chart abstraction
Time frame: 3 months post study enrollment
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
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
Count of quit attempts lasting at least 24 hours, measured by participant self-report at the 3-month follow-up assessment.
Time frame: Baseline and at 3 months post-enrollment
The Lung Cancer Screening Knowledge Measure (published as "a brief measure of smokers' knowledge of lung cancer screening with low-dose computed tomography") is a 12-item instrument assessing knowledge of lung cancer screening eligibility, benefits, and harms. One point is awarded per correct response. Total score ranges from 0 (minimum) to 12 (maximum). Higher scores indicate greater knowledge and are a better outcome.
Time frame: At baseline and at 3 months post-enrollment
The Lung Cancer Screening Health Belief Scales are a 35-item instrument based on the Expanded Health Belief Model. The Perceived Risk of Lung Cancer subscale comprises 3 items rated on a 4-point Likert scale from 1 (strongly disagree) to 4 (strongly agree). The subscale score is the mean of the item responses and ranges from 1 (minimum) to 4 (maximum). Higher scores indicate greater perceived personal risk of lung cancer. This construct is not inherently better or worse; higher perceived risk is hypothesized to be associated with greater screening uptake.
Time frame: At baseline and at 3 months post-enrollment
The Perceived Benefits subscale comprises 6 items rated on a 4-point Likert scale from 1 (strongly disagree) to 4 (strongly agree). The subscale score is the mean of the item responses and ranges from 1 (minimum) to 4 (maximum). Higher scores indicate greater perceived benefit of lung cancer screening and are a better outcome.
Time frame: At baseline and at 3 months post-enrollment
The Perceived Barriers subscale comprises 17 items rated on a 4-point Likert scale from 1 (strongly disagree) to 4 (strongly agree). The subscale score is the mean of the item responses and ranges from 1 (minimum) to 4 (maximum). Higher scores indicate greater perceived barriers to lung cancer screening and are a worse outcome.
Time frame: At baseline and at 3 months post-enrollment
The Self-Efficacy subscale comprises 9 items rated on a 4-point Likert scale from 1 (strongly disagree) to 4 (strongly agree), assessing patient confidence in the ability to arrange and complete lung cancer screening. The subscale score is the mean of the item responses and ranges from 1 (minimum) to 4 (maximum). Higher scores indicate greater self-efficacy and are a better outcome.
Time frame: 3 months post-enrollment
Trust in Navigator Scale: 6-item instrument developed to measure interpersonal trust in a patient's navigator (i.e., the CHW), adapted from the trust in physician scale. Items are rated on a 5-point Likert scale. The score is the mean of the 6 item responses and ranges from 1 (minimum) to 5 (maximum) with higher mean scores indicating greater trust.
Time frame: 3 months post-enrollment
The Shared Decision Making Process Scale (also referred to as the SDM Process Survey; National Quality Forum measure 2962) is a 4-item patient-reported instrument assessing whether the clinical conversation addressed the benefits of the option, addressed the harms of the option, and elicited the patient's preference. Total score ranges from 0 (minimum) to 4 (maximum). Higher scores indicate a more complete shared decision making process and are a better outcome.
Contact information is provided by the study sponsor or research team.
Chisom Unegbu, BS
CONTACT
Eduardo R Nunez, MD, MS
CONTACT
Baystate Medical Center
Other
Acronym: CHATS
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