A Tailored Screening and Smoking Cessation Program for the LGBTQ Community of Seattle

Study Overview
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Brief Summary
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This clinical trial develops a tailored screening and smoking cessation program for the lesbian, gay, bisexual, transgender (trans) and queer (LGBTQ) community of Seattle, Washington. A lung cancer screening program may help LGTBQ people who smoke overcome unique barriers that keep them from receiving preventive care, and constantly facing healthcare discrimination. Members of the LGBTQ community have historically smoked at higher rates than the general population and thus could benefit greatly from targeted efforts to improve lung cancer screening and smoking cessation implementation.

Detailed Description
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OUTLINE: AIM 1: Stakeholders (community organization leaders, medical providers of LGBTQ patients, and LGBTQ community members and tobacco users) participate in an interview over 45 minutes to 1 hour. AIM 2: Participants participate in focus groups over 1-1.5 hours. AIM 3: Participants receive a patient navigation intervention consisting of a series of points of contact (mostly via telephone) between the patient navigator/tobacco treatment specialist (PN/TTS) and includes: 1) An introduction and enrollment in LCS, 2) facilitation of a shared decision-making (SDM) visit with the LCS-dedicated nurse practitioner, 3) individual assessment of barriers and facilitators to in-person low-dose CT screening, 4) explanation of results and needed follow-up, and 5) follow-up reminders. Participants also undergo carbon monoxide measurement by exhaling into a disposable monitor for 10 seconds at the initial visit and the post-intervention visit. The PN may also provide an intervention for smoking cessation. After completion of Aim 3 study intervention, participants are followed up at 3 months.

Official Title
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Tailoring Screening and Smoking Cessation for the LGBTQ Community

Conditions
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Lung Carcinoma

Intervention / Treatment
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* Behavioral: Patient Navigation
* Other: Questionnaire Administration
* Behavioral: Smoking Cessation Intervention
* Procedure: Carbon Monoxide Measurement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: AIM 1 MEDICAL PROVIDER OF LGBTQ PATIENTS: Age minimum of 18 AIM 1 MEDICAL PROVIDER OF LGBTQ PATIENTS: Affiliation with Cancer Consortium, Seattle's LGBTQ Center, or other organization serving LGBTQ persons AIM 1 MEDICAL PROVIDER OF LGBTQ PATIENTS: Identifies as providing primary care or specialty care to largely LGBTQ population (doctor of medicine [MD], registered nurse [RN], physician assistants [PA], advanced registered nurse practitioner [ARNP]) AIM 1, COMMUNITY ORGANIZATION LEADERS: Age minimum of 18 AIM 1, COMMUNITY ORGANIZATION LEADERS: Broadly defined as community leader (i.e. leadership in Seattle-area volunteer, philanthropic, community service groups) in discussions with with community-based participatory research (CBPR) partners AIM 2: Current cigarette smoker (defined as actively smoking within the last 6 months, this is consistent with (c/w) standard and Seattle Cancer Care Alliance (SCCA) definition of current smoker) or former cigarette smoker AIM 2: Aged 50-80 years AIM 2: At least 20 pack-year smoking history AIM 3: Identify as a member of the LGBTQ community AIM 3: Eligible for no-cost sharing LCS based on United States Preventive Services Task Force (USPSTF) criteria As of Jan 2022: aged 50-80 years, at least 20 pack-year smoking history, and currently smoke tobacco cigarettes [as this intervention is based around current cigarette smokers (as defined above)], former cigarette smokers not included in this Aim Exclusion Criteria: AIM 1: Non-English speaking participants AIM 2: Those found to be ineligible for LCS on coordinator review; or who are non-English speaking or have cognitive dysfunction that would prevent participation in SDM AIM 3: Those found to be ineligible for LCS on coordinator review; or who are non-English speaking or have cognitive dysfunction that would prevent participation in SDM

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Health services research (patient navigation intervention)<br>Participants receive a patient navigation intervention consisting of a series of points of contact (mostly via telephone) between the PN/TTS and includes: 1) An introduction and enrollment in LCS, 2) facilitation of a SDM visit with the LCS-dedicated nurse practitioner, 3) individual assessment of barriers and facilitators to in-person low-dose CT screening, 4) explanation of results and needed follow-up, and 5) follow-up reminders. Participants also undergo carbon monoxide measurement by exhaling into a disposable monitor for 10 seconds at the initial visit and the post-intervention visit. The PN may also provide an intervention for smoking cessation. | Behavioral: Patient Navigation<br>* Receive patient navigation intervention<br>* Other names: Patient Navigator Program;Other: Questionnaire Administration<br>* Ancillary studies<br>Behavioral: Smoking Cessation Intervention<br>* Receive an intervention for smoking cessation<br>* Other names: Smoking and Tobacco Use Cessation Interventions;Procedure: Carbon Monoxide Measurement<br>* Undergo carbon monoxide measurement<br>* Other names: CMONOX;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of lesbian, gay, bisexual, transgender (trans) and queer (LGBTQ) community stakeholders who participate in the Aim 1 interviews/focus groups (Aim 1) |  | Up to 3 months | 
| Number of LBGTQ community members who participate in the Aim 2 focus groups (Aim 2) |  | Up to 9 months | 
| Acceptability of patient navigation and smoking cessation interventions (Aim 3) | The Acceptability of Intervention Measure (AIM) will be summarized and presented as range of scores from 1 (low acceptability) to 5 (high acceptability), with at least 75% of participants giving the interventions at least a 4, the threshold for acceptability. | Up to 12 months | 
| Patient satisfaction with navigator throughout navigation and smoking cessation interventions (Aim 3) | The Patient Satisfaction with Navigator (PSN-1) will also be summarized and presented as range of scores from 1 (high satisfaction) to 5 (low satisfaction), with at least 75% of participants giving the navigator interactions at maximum a 2, the threshold for satisfaction. | Up to 12 months | 
| Effectiveness of navigation visit(s): knowledge (Aim 3) | Pre- and post-intervention Lung cancer screening Knowledge Survey (LKS) responses will be compared via Cochran-Mantel-Haenszel tests for all categorical data. | Up to 12 months | 
| Effectiveness of navigation visit(s): smoking cessation (Aim 3) | Initiation of pharmacotherapy and/or behavioral treatment, floating cigarette abstinence (>7 days abstinence among those currently smoking at intervention start date, as defined in post-intervention survey) [Aim 3] | Up to 12 months |