Clinical trial NCT05304390: A Tailored Screening and Smoking Cessation Program for the LGBTQ Community of Seattle
Official title: Tailoring Screening and Smoking Cessation for the LGBTQ Community
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Lung Carcinoma
Lead sponsor: Fred Hutchinson Cancer Center
Sponsor class: OTHER
Collaborators: name: LUNGevity Foundation
First posted: 2022-03-31
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of lesbian, gay, bisexual, transgender (trans) and queer (LGBTQ) community stakeholders who participate in the Aim 1 interviews/focus groups (Aim 1)
timeFrame: Up to 3 months
measure: Number of LBGTQ community members who participate in the Aim 2 focus groups (Aim 2)
timeFrame: Up to 9 months
measure: Acceptability of patient navigation and smoking cessation interventions (Aim 3)
timeFrame: Up to 12 months
measure: Patient satisfaction with navigator throughout navigation and smoking cessation interventions (Aim 3)
timeFrame: Up to 12 months
measure: Effectiveness of navigation visit(s): knowledge (Aim 3)
timeFrame: Up to 12 months
measure: Effectiveness of navigation visit(s): smoking cessation (Aim 3)
timeFrame: Up to 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Fred Hutch/University of Washington Cancer Consortium
state: Washington
Study officials:
affiliation: Fred Hutch/University of Washington Cancer Consortium
name: Matthew Triplette
role: PRINCIPAL_INVESTIGATOR
References: