Baystate Health
Springfield, Massachusetts, 01107, United States
Location status: Recruiting
NCT Number: NCT07168629
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.
Interested in participating?
Request Info50 year–80 year
All sexes
Interventional
Not applicable
Springfield, Massachusetts, 01107, United States
Location status: Recruiting
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.
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) 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.
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) and lay navigators 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) and lay navigators 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 and lay navigator 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 and lay navigator encounter log.
Time frame: 3 months post-enrollment (participants) and through study completion, an average of 1 year (navigators)
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)
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 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, 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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