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

Sponsor
Fred Hutchinson Cancer Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT05304390
Collaborator
(none)
50
Enrollment
1
Location
1
Arm
13.7
Anticipated Duration (Months)
3.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Patient Navigation
  • Other: Questionnaire Administration
  • Behavioral: Smoking Cessation Intervention
 N/A

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. Community members participate in focus groups over 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. The PN may also provide an intervention for smoking cessation.

After completion of Aim 3 study intervention, participants are followed up at 3 months.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
Tailoring Screening and Smoking Cessation for the LGBTQ Community
Anticipated Study Start Date :
Sep 11, 2022
Anticipated Primary Completion Date :
Nov 1, 2023
Anticipated Study Completion Date :
Nov 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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. The PN may also provide an intervention for smoking cessation.

Behavioral: Patient Navigation
Receive patient navigation intervention
Other Names:
  • Patient Navigator Program

    • Other: Questionnaire Administration
    Ancillary studies

    Behavioral: Smoking Cessation Intervention
    Receive an intervention for smoking cessation
    Other Names:
  • Smoking and Tobacco Use Cessation Interventions

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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]

    2. Number of LBGTQ community members who participate in the Aim 2 focus groups (Aim 2) [Up to 9 months]

    3. Acceptability of patient navigation and smoking cessation interventions (Aim 2) [Up to 12 months]

      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.

    4. Appropriateness of patient navigation and smoking cessation interventions (Aim 3) [Up to 12 months]

      The Intervention Appropriateness Measure (IAM) will be summarized and presented as range of scores from 1 (low appropriateness) to 5 (high appropriateness), with at least 75% of participants giving the interventions at least a "4" the threshold for appropriateness.

    5. Effectiveness of shared decision making visit: knowledge (Aim 3) [Up to 12 months]

      Pre- and post-intervention Lung cancer screening Knowledge Survey (LKS) responses will be compared via Cochran-Mantel-Haenszel tests for all categorical data.

    6. Effectiveness of shared decision making visit: decisional conflict (Aim 3) [Up to 12 months]

      The Decisional Conflict Scale (DCS) will be summarized as the median for participants from 0 (extreme certainty) to 100 (extreme uncertainty).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • AIM 1: The study team and Gay City representatives will meet to broadly identify community members considered key stakeholders in smoking cessation and screening initiatives. A purposive sample of LGBTQ tobacco users will be sought to ensure representation by trans-identified individuals and persons of color. There are no strict inclusion/exclusion criteria for this Aim as this is a formative evaluation to determine community needs and recruitment strategy.

    • Aim 1: Participant is either 1) community organization leaders (n=5), 2) medical provider of LGBTQ patients (n=5), or 3) an LGBTQ community members with variable smoking history (n=20).

    • AIM 2: Participant (n=30) identifies as LGBTQ community member

    • AIM 2: Current smokers

    • AIM 2: Eligible for LCS (those aged 50-80 with at least a 20 pack-year smoking history)

    • AIM 3: Participant identifies as LGBTQ community members

    • AIM 3: Currently uses tobacco

    • AIM 3: Eligible for no-cost sharing LCS based on United States Preventive Services Task Force (USPSTF) criteria

    Exclusion Criteria:

    • AIM 1: Non-English speaking participants

    • AIM 2: Individuals ineligible for LCS on coordinator review

    • AIM 2: Non-English speakers

    • AIM 2: Those with cognitive dysfunction that would prevent participation in SDM

    • AIM 3: Individuals ineligible for LCS on coordinator review

    • AIM 3: Non-English speakers

    • AIM 3: Those with cognitive dysfunction that would prevent participation in SDM.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Fred Hutch/University of Washington Cancer Consortium Seattle Washington United States 98109

    Sponsors and Collaborators

    • Fred Hutchinson Cancer Center

    Investigators

    • Principal Investigator: Matthew Triplette, Fred Hutch/University of Washington Cancer Consortium

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Fred Hutchinson Cancer Center
    ClinicalTrials.gov Identifier:
    NCT05304390
    Other Study ID Numbers:
    • RG1122073
    • NCI-2022-01427
    • 10815
    First Posted:
    Mar 31, 2022
    Last Update Posted:
    Aug 15, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Lung Neoplasms

    Study Results

    No Results Posted as of Aug 15, 2022