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

NCT05304390 | Terminated

• 3 other identifiers: RG1122073NCI-2022-0142710815
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lung Carcinoma

Outcome Measures

Primary Outcomes (6)

• 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

Study Arms (1)

Health services research (patient navigation intervention)

EXPERIMENTAL

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; Other: Questionnaire Administration; Behavioral: Smoking Cessation Intervention; Procedure: Carbon Monoxide Measurement

Interventions

Patient Navigation BEHAVIORAL

Receive patient navigation intervention

Also known as: Patient Navigator Program

Health services research (patient navigation intervention)

Questionnaire Administration OTHER

Ancillary studies

Health services research (patient navigation intervention)

Smoking Cessation Intervention BEHAVIORAL

Receive an intervention for smoking cessation

Also known as: Smoking and Tobacco Use Cessation Interventions

Health services research (patient navigation intervention)

Carbon Monoxide Measurement PROCEDURE

Undergo carbon monoxide measurement

Also known as: CMONOX

Health services research (patient navigation intervention)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fred Hutchinson Cancer Center: lead
• LUNGevity Foundation: collaborator

Study Sites (1)

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

Location

Related Publications (1)

• Triplette M, Omernik B, Snidarich M, Heffner JL, Brooks E, Crothers K, Brown MC, Murphy NR, Louie T. Tailored Patient Navigation to Support Lung Cancer Screening and Smoking Cessation in LGBTQ+ Individuals: A Pilot Study. Ann Am Thorac Soc. 2025 Oct;22(10):1592-1600. doi: 10.1513/AnnalsATS.202502-215OC.

  PMID: 40440319 DERIVED

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Patient Navigation; Smoking Devices; Carbon Monoxide

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Patient-Centered Care; Primary Health Care; Comprehensive Health Care; Patient Care Management; Health Services Administration; Manufactured Materials; Technology, Industry, and Agriculture; Carbon Compounds, Inorganic; Inorganic Chemicals; Gases; Oxides; Oxygen Compounds

Study Officials

• Matthew Triplette

  Fred Hutch/University of Washington Cancer Consortium

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2022
• First Posted: March 31, 2022
• Study Start: June 6, 2022
• Primary Completion: October 28, 2024
• Study Completion: October 28, 2024
• Last Updated: December 2, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)