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| ID | Type | Description | Link |
|---|---|---|---|
| 1K08CA289097-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Enhanced Usual Care | Active Comparator | Will receive educational materials about lung cancer screening and tobacco treatment. |
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| Intervention | Experimental | Will receive a four-part community health worker-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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Community health worker delivered outreach, shared decision-making, tobacco treatment, and navigation | Behavioral | The CHW will perform: 1) patient outreach 2) patient-centered shared-decision making, 3) smoking cessation counseling, and 4) navigation of logistical barriers |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | 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. | once a month until study trial ends, an average of 1 year |
| Fidelity | SDM aid use and resources utilized | 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| LCS referral | Referral for LCS: Order either by CHW or PCP referring participant to LCS program. | 3 months post study enrollment |
| LCS uptake | Receipt of LCS pre and post intervention |
| Measure | Description | Time Frame |
|---|---|---|
| LCS knowledge | LCS knowledge LCS-12: 12-item instrument measuring LCS knowledge, indications for screening and potential risks | Baseline and at 3 months post-enrollment |
| LCS beliefs and barriers | LCS Health Belief Scale: 35-item instrument based on the Expanded Health Belief Model that measures perceived risk of lung cancer (3 items), knowledge and perceived LCS benefits (6 items), perceived LCS barriers (17 items), and self-efficacy (9 items; e.g. patient confidence in ability to arrange and complete LCS). Item responses use a 4-point Likert scale (e.g. strongly agree to strongly disagree). |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Eduardo R Nunez, MD, MS | Contact | 1-855-794-5864 | Eduardo.nunez2@baystatehealth.org | |
| Chisom Unegbu, BS | Contact | CHISOM.UNEGBU@baystatehealth.org |
| Name | Affiliation | Role |
|---|---|---|
| Jennifer Pacheco | Baystate Health | Study Director |
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Sharing qualitative data such as transcriptions from interviews can potentially reveal sensitive information and identify individual participants. The higher level of redaction needed to remove potentially-identifying and sensitive information would substantially reduce the utility of transcripts in future analyses.To ensure this group's participation and honest responses, we will not share transcripts or coding summaries from participant or community health worker interviews.
The goal of this pilot trial is to provide preliminary information to support a future fully powered randomized trial to address disparities in lung cancer in Black and Hispanic communities. Given that these community members have historically been subject to unethical research practices, we will limit the potential for further distrust by not sharing de-identified information outside of the study team or its collaborators.
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Randomized Control Trial
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| Enhanced Usual Care | Other | 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. |
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| 3 months post enrollment (for study participant) and through study completion, an average of 1 year (for CHW staff) |
| Baseline and post intervention, 3 months post study enrollment |
| Tobacco Treatment receipt | Receipt of tobacco treatment: initiation and type of treatment | 3 months post study enrollment |
| Tobacco Treatment Duration | Duration of tobacco treatment and cessation attempts. | 3 months post study enrollment |
| Tobacco Cessation | Tobacco Cessation: # of quit attempts | 3 months post study enrollment |
| At baseline and at 3 months post-enrollment |
| Trust in Navigator | 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. | 3 months post-enrollment |
| Values-based SDM | SDM Process Survey: 4-item scale that measures whether the conversation discussed harms and benefits, and decisional preferences. | 3 months post-enrollment |
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D064424 | Tobacco Use |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D001519 | Behavior |
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