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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05304390
Recruitment Status : Recruiting
First Posted : March 31, 2022
Last Update Posted : July 13, 2022
Sponsor:
Information provided by (Responsible Party):
Fred Hutchinson Cancer Center

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
Lung Carcinoma Behavioral: Patient Navigation Other: Questionnaire Administration Behavioral: Smoking Cessation Intervention Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Study Start Date : August 11, 2022
Estimated Primary Completion Date : November 1, 2023
Estimated Study Completion Date : November 1, 2023

Resource links provided by the National Library of Medicine


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 Name: Patient Navigator Program

Other: Questionnaire Administration
Ancillary studies

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




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) [ Time Frame: Up to 3 months ]
  2. Number of LBGTQ community members who participate in the Aim 2 focus groups (Aim 2) [ Time Frame: Up to 9 months ]
  3. Acceptability of patient navigation and smoking cessation interventions (Aim 2) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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).



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05304390


Contacts
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Contact: Matthew Triplette 206.667.6335 mtriplet@fredhutch.org

Locations
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United States, Washington
Fred Hutch/University of Washington Cancer Consortium Recruiting
Seattle, Washington, United States, 98109
Contact: Matthew Triplette    206-667-6335    mtriplet@fredhutch.org   
Principal Investigator: Matthew Triplette         
Sponsors and Collaborators
Fred Hutchinson Cancer Center
Investigators
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Principal Investigator: Matthew Triplette Fred Hutch/University of Washington Cancer Consortium
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Responsible Party: Fred Hutchinson Cancer Center
ClinicalTrials.gov Identifier: NCT05304390    
Other Study ID Numbers: RG1122073
NCI-2022-01427 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
10815 ( Other Identifier: Fred Hutch/University of Washington Cancer Consortium )
First Posted: March 31, 2022    Key Record Dates
Last Update Posted: July 13, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases