Lung Cancer, Tobacco Use
Conditions
Keywords
lung cancer screening, tobacco treatment, community health workers, community health centers
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALCommunity health worker delivered outreach, shared decision-making, tobacco treatment, and navigation
The CHW will perform: 1) patient outreach 2) patient-centered shared-decision making, 3) smoking cessation counseling, and 4) navigation of logistical barriers
OTHEREnhanced Usual Care
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.
Sponsors
Baystate Medical Center
National Cancer Institute (NCI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
Randomized Control Trial
Eligibility
Sex/Gender
ALL
Age
50 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility: Number of participants at each stage of the recruitment and retention cascade | 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. |
| Feasibility: Percentage of participants at each stage of the recruitment and retention cascade | 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. |
| Fidelity: Duration in minutes of shared decision making (SDM) counseling per encounter | 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. |
| Fidelity: Duration in minutes of smoking cessation counseling per encounter | 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. |
| Fidelity - SDM quality using OPTION Scale Observer OPTION Scale | 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. |
| Fidelity - Completion of SDM required elements | 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. |
| Fidelity: Percentage of participants with documented use of the SDM decision aid | 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. |
| Fidelity: Percentage of participants referred to tobacco treatment services, by type | 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. |
| Acceptability of the CHW intervention to participants | 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; |
| Acceptability of the CHW intervention to CHWs | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of participants with a lung cancer screening (LCS) referral order | 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). |
| Percentage of participants completing low-dose CT lung cancer screening (LCS uptake) | 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 |
| Percentage of participants initiating tobacco treatment, by treatment type | 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. |
| Duration in weeks of tobacco treatment | 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. |
| Number of self-reported quit attempts per participant | 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. |
Countries
United States
Contacts
CONTACTEduardo R Nunez, MD, MS
CONTACTChisom Unegbu, BS
STUDY_DIRECTORJennifer Pacheco
Baystate Health
Outcome results
None listed