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

NCT ID: NCT05304390

Last Updated: 2024-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

53 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-06

Study Completion Date

2024-10-28

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.

Conditions

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Lung Carcinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Patient Navigation

Intervention Type BEHAVIORAL

Receive patient navigation intervention

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Smoking Cessation Intervention

Intervention Type BEHAVIORAL

Receive an intervention for smoking cessation

Carbon Monoxide Measurement

Intervention Type PROCEDURE

Undergo carbon monoxide measurement

Interventions

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Patient Navigation

Receive patient navigation intervention

Intervention Type BEHAVIORAL

Questionnaire Administration

Ancillary studies

Intervention Type OTHER

Smoking Cessation Intervention

Receive an intervention for smoking cessation

Intervention Type BEHAVIORAL

Carbon Monoxide Measurement

Undergo carbon monoxide measurement

Intervention Type PROCEDURE

Other Intervention Names

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Patient Navigator Program Smoking and Tobacco Use Cessation Interventions CMONOX

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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LUNGevity Foundation

OTHER

Sponsor Role collaborator

Fred Hutchinson Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Matthew Triplette

Role: PRINCIPAL_INVESTIGATOR

Fred Hutch/University of Washington Cancer Consortium

Locations

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Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 40440319 (View on PubMed)

Provided Documents

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Document Type: Informed Consent Form

View Document

Other Identifiers

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NCI-2022-01427

Identifier Type: REGISTRY

Identifier Source: secondary_id

10815

Identifier Type: OTHER

Identifier Source: secondary_id

RG1122073

Identifier Type: -

Identifier Source: org_study_id