About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Parallel
Treatments tested in this trial
Community health worker delivered outreach, shared decision-making, tobacco treatment, and navigation
BehavioralThe CHW will perform: 1) patient outreach 2) patient-centered shared-decision making, 3) tobacco treatmnet counseling, and 4) navigation of logistical barriers
Lay Navigator delivered outreach, shared decision-making, tobacco treatment, and navigation
BehavioralThe lay navigator will perform: 1) patient outreach 2) patient-centered shared-decision making, 3) tobacco treatment counseling, and 4) navigation of logistical barriers
Enhanced Usual Care
Other interventionParticipants will receive educational materials about lung cancer screening and usual lung cancer screening care through their primary care provider.
Treatment groups
Trial outcomes
Primary outcomes
Feasibility: 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.
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.
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.
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.
Secondary outcomes
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).
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
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.
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.
Other outcomes
Mean score on the LCS-12 lung cancer screening knowledge instrument
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.
Mean score on the Perceived Risk of Lung Cancer subscale of the Lung Cancer Screening Health Belief Scales
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.
Mean score on the Perceived Benefits of Lung Cancer Screening subscale of the Lung Cancer Screening Health Belief Scales
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.
Mean score on the Perceived Barriers to Lung Cancer Screening subscale of the Lung Cancer Screening Health Belief Scales
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.
Sponsors and contacts
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Baystate Medical Center
Lead sponsor
National Cancer Institute (NCI)
Collaborator