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Lung CarcinomaNCT05304390

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

A study testing Patient Navigation, Questionnaire Administration and Smoking Cessation Intervention in people with Lung Carcinoma, run by Fred Hutchinson Cancer Center at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Lung Carcinoma
What is being tested?
Patient Navigation, Questionnaire Administration and Smoking Cessation Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
53 participants
Where
1 siteUnited States
Study dates
6 Jun 2022to 28 Oct 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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
Show all 11Show fewer
  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Fred Hutch/University of Washington Cancer Consortium

    Seattle, Washington, 98109

Other trials in United States

About this study

Official title: 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.

Read the 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.

Conditions
Lung Carcinoma
Being tested
Patient Navigation, Questionnaire Administration, Smoking Cessation Intervention, Carbon Monoxide Measurement
Medical subject headings
Lung Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Patient NavigationBehavioural

    Also called Patient Navigator Program

    Receive patient navigation intervention

  • Questionnaire AdministrationOther

    Ancillary studies

  • Smoking Cessation InterventionBehavioural

    Also called Smoking and Tobacco Use Cessation Interventions

    Receive an intervention for smoking cessation

  • Carbon Monoxide MeasurementProcedure or surgery

    Also called CMONOX

    Undergo carbon monoxide measurement

Study groups in NCT05304390
Study groupRoleWhat they receive
Health services research (patient navigation intervention)ExperimentalParticipants 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.
Receives: Behavioral: Patient Navigation; Other: Questionnaire Administration; Behavioral: Smoking Cessation Intervention; Procedure: Carbon Monoxide Measurement

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of lesbian, gay, bisexual, transgender (trans) and queer (LGBTQ) community stakeholders who participate in the Aim 1 interviews/focus groups (Aim 1)

    Measured: Up to 3 months

  2. Number of LBGTQ community members who participate in the Aim 2 focus groups (Aim 2)

    Measured: Up to 9 months

  3. 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.

    Measured: Up to 12 months

  4. 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.

    Measured: Up to 12 months

  5. 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.

    Measured: Up to 12 months

  6. 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]

    Measured: Up to 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Mar 2022
  2. Study start6 Jun 2022
  3. Primary completion28 Oct 2024
  4. Study completion28 Oct 2024

Why it stopped: Terminated due to end of funding. Enrollment sufficient to evaluate primary and secondary outcomes measures.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
53 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05304390
Sponsor's protocol ID
RG1122073
Other IDs
NCI-2022-01427, 10815
Status last verified
Nov 2024
First submitted
8 Mar 2022
Last updated
2 Dec 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 40440319

Questions about this trial

What is this clinical trial studying?

A study testing Patient Navigation, Questionnaire Administration and Smoking Cessation Intervention in people with Lung Carcinoma, run by Fred Hutchinson Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 2 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Terminated due to end of funding. Enrollment sufficient to evaluate primary and secondary outcomes measures.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of lesbian, gay, bisexual, transgender (trans) and queer (LGBTQ) community stakeholders who participate in the Aim 1 interviews/focus groups (Aim 1) (time frame: Up to 3 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05304390, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2024.

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