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

Tailoring Screening and Smoking Cessation for the LGBTQ Community

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.

Study Overview

• Status: Terminated
• Conditions: Lung Carcinoma
• Intervention / Treatment: Other: Questionnaire Administration; Behavioral: Patient Navigation; Behavioral: Smoking Cessation Intervention; Procedure: Carbon Monoxide Measurement

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 53
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98109
      • Fred Hutch/University of Washington Cancer Consortium

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Health services research (patient navigation intervention); 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.

Other: Questionnaire Administration; Ancillary studies; Behavioral: Patient Navigation; Receive patient navigation intervention; Other Names: Patient Navigator Program; Behavioral: Smoking Cessation Intervention; Receive an intervention for smoking cessation; Other Names: Smoking and Tobacco Use Cessation Interventions; Procedure: Carbon Monoxide Measurement; Undergo carbon monoxide measurement; Other Names: CMONOX

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Fred Hutchinson Cancer Center
• Collaborators: LUNGevity Foundation
• Investigators: Principal Investigator: Matthew Triplette, Fred Hutch/University of Washington Cancer Consortium

Study record dates

Study Major Dates

• Study Start (Actual): June 6, 2022
• Primary Completion (Actual): October 28, 2024
• Study Completion (Actual): October 28, 2024

Study Registration Dates

• First Submitted: March 8, 2022
• First Submitted That Met QC Criteria: March 22, 2022
• First Posted (Actual): March 31, 2022

Study Record Updates

• Last Update Posted (Estimated): December 2, 2024
• Last Update Submitted That Met QC Criteria: November 27, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antimetabolites; Neurotransmitter Agents; Gasotransmitters; Carbon Monoxide
• Other Study ID Numbers: RG1122073; NCI-2022-01427 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); 10815 (Other Identifier: Fred Hutch/University of Washington Cancer Consortium)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No