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

Lung Carcinoma Clinical Trial

Official title:

Tailoring Screening and Smoking Cessation for the LGBTQ Community

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05304390
• Other study ID #: RG1122073
• Secondary ID: NCI-2022-0142710
• Status: Recruiting
• Phase: N/A
• Start date: June 6, 2022
• Est. completion date: November 15, 2024

Study information

• Verified date: May 2024
• Source: Fred Hutchinson Cancer Center
• Contact: Matthew Triplette
• Phone: 206.667.6335
• Email: mtriplet[@]fredhutch.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 61
• Est. completion date: November 15, 2024
• Est. primary completion date: November 15, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lung Carcinoma
• Lung Neoplasms

Intervention

Behavioral:
• Patient Navigation
Receive patient navigation intervention

Other:
• Questionnaire Administration
Ancillary studies

Behavioral:
• Smoking Cessation Intervention
Receive an intervention for smoking cessation

Procedure:
• Carbon Monoxide Measurement
Undergo carbon monoxide measurement

Locations

Country	Name	City	State
United States	Fred Hutch/University of Washington Cancer Consortium	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Fred Hutchinson Cancer Center	LUNGevity Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Number of LBGTQ community members who participate in the Aim 2 focus groups (Aim 2)		Up to 9 months
Primary	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
Primary	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
Primary	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
Primary	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