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

Primary Purpose

Lung Carcinoma

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Patient Navigation
Questionnaire Administration
Smoking Cessation Intervention
Carbon Monoxide Measurement
Sponsored by
Fred Hutchinson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Lung Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Fred Hutch/University of Washington Cancer ConsortiumRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Health services research (patient navigation intervention)

Arm Description

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.

Outcomes

Primary Outcome Measures

Number of lesbian, gay, bisexual, transgender (trans) and queer (LGBTQ) community stakeholders who participate in the Aim 1 interviews/focus groups (Aim 1)
Number of LBGTQ community members who participate in the Aim 2 focus groups (Aim 2)
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.
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.
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.
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]

Secondary Outcome Measures

Full Information

First Posted
March 8, 2022
Last Updated
September 20, 2023
Sponsor
Fred Hutchinson Cancer Center
Collaborators
LUNGevity Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT05304390
Brief Title
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

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 6, 2022 (Actual)
Primary Completion Date
November 1, 2023 (Anticipated)
Study Completion Date
November 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fred Hutchinson Cancer Center
Collaborators
LUNGevity Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Carcinoma

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
61 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Health services research (patient navigation intervention)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Patient Navigation
Other Intervention Name(s)
Patient Navigator Program
Intervention Description
Receive patient navigation intervention
Intervention Type
Other
Intervention Name(s)
Questionnaire Administration
Intervention Description
Ancillary studies
Intervention Type
Behavioral
Intervention Name(s)
Smoking Cessation Intervention
Other Intervention Name(s)
Smoking and Tobacco Use Cessation Interventions
Intervention Description
Receive an intervention for smoking cessation
Intervention Type
Procedure
Intervention Name(s)
Carbon Monoxide Measurement
Other Intervention Name(s)
CMONOX
Intervention Description
Undergo carbon monoxide measurement
Primary Outcome Measure Information:
Title
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
Title
Number of LBGTQ community members who participate in the Aim 2 focus groups (Aim 2)
Time Frame
Up to 9 months
Title
Acceptability of patient navigation and smoking cessation interventions (Aim 3)
Description
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.
Time Frame
Up to 12 months
Title
Patient satisfaction with navigator throughout navigation and smoking cessation interventions (Aim 3)
Description
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.
Time Frame
Up to 12 months
Title
Effectiveness of navigation visit(s): knowledge (Aim 3)
Description
Pre- and post-intervention Lung cancer screening Knowledge Survey (LKS) responses will be compared via Cochran-Mantel-Haenszel tests for all categorical data.
Time Frame
Up to 12 months
Title
Effectiveness of navigation visit(s): smoking cessation (Aim 3)
Description
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]
Time Frame
Up to 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Matthew Triplette
Phone
206.667.6335
Email
mtriplet@fredhutch.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthew Triplette
Organizational Affiliation
Fred Hutch/University of Washington Cancer Consortium
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fred Hutch/University of Washington Cancer Consortium
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matthew Triplette
Phone
206-667-6335
Email
mtriplet@fredhutch.org
First Name & Middle Initial & Last Name & Degree
Matthew Triplette

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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