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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2022-01427 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 10815 | Other Identifier | Fred Hutch/University of Washington Cancer Consortium |
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Terminated due to end of funding. Enrollment sufficient to evaluate primary and secondary outcomes measures.
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| Name | Class |
|---|---|
| LUNGevity Foundation | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Health services research (patient navigation intervention) | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Patient Navigation | Behavioral | Receive patient navigation intervention |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
| Number of LBGTQ community members who participate in the Aim 2 focus groups (Aim 2) | Up to 9 months | |
| 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. | Up to 12 months |
| 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. | Up to 12 months |
| 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. | Up to 12 months |
| 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] |
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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
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Matthew Triplette | Fred Hutch/University of Washington Cancer Consortium | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fred Hutch/University of Washington Cancer Consortium | Seattle | Washington | 98109 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40440319 | Derived | 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. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Jan 24, 2024 | Nov 4, 2024 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D062526 | Patient Navigation |
| D000074602 | Smoking Devices |
| D002248 | Carbon Monoxide |
| ID | Term |
|---|---|
| D018802 | Patient-Centered Care |
| D011320 | Primary Health Care |
| D003191 | Comprehensive Health Care |
| D010346 | Patient Care Management |
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| Questionnaire Administration | Other | Ancillary studies |
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| Smoking Cessation Intervention | Behavioral | Receive an intervention for smoking cessation |
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| Carbon Monoxide Measurement | Procedure | Undergo carbon monoxide measurement |
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| Up to 12 months |
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D006298 | Health Services Administration |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
| D017554 | Carbon Compounds, Inorganic |
| D007287 | Inorganic Chemicals |
| D005740 | Gases |
| D010087 | Oxides |
| D017601 | Oxygen Compounds |