Clinical trial NCT04682301: Tailoring Shared Decision Making for Lung Cancer Screening in Persons Living With HIV
Official title: Tailoring Shared Decision Making for Lung Cancer Screening in Persons With HIV (PWH)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Carcinoma
Lead sponsor: Fred Hutchinson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2020-12-23
Enrollment: 102
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: PWH enrolled in the local University of Washington (UW) HIV cohort and primary providers at Madison Clinic

Brief summary: This study tailors a shared decision making intervention for lung cancer screening in persons living with human immunodeficiency virus (HIV). Information collected in this study may help doctors better understand how to perform lung cancer screening in persons living with HIV, so as to enhance shared decision making in persons living with HIV.

Detailed description: OUTLINE:

AIM I: Participants attend a focus group over 1-1.5 hours providing feedback on refining potential methods of shared decision making (SDM).

AIM II: Participants receive the SDM intervention developed in Aim I and provide feedback. Participants may attend a telephone interview over 45 minutes 1 month later.

Eligibility criteria: Inclusion Criteria:

* AIM I: Patients with human immunodeficiency virus (PWH) enrolled in the local UW HIV cohort and primary providers at Madison Clinic and other Seattle-based clinics serving PWH
* AIM I: Using proposed United States Preventive Services Task Force (USPSTF) guidelines, participants enrolled in the registry who are current or former smokers, report \>= 20 pack-years smoking history, and \>= 50 years old (n=165) will be eligible for recruitment
* AIM I: Clinicians (medical doctors, physicians assistants and nurse practitioners) who provide primary care for PWH (n=48) will be eligible
* AIM II: PWH who are eligible for lung cancer screening (LCS) based on proposed USPSTF criteria

Exclusion Criteria:

* Those found to be ineligible for LCS on coordinator review
* Are non-English speaking or have cognitive dysfunction that would prevent participation in SDM

Primary outcomes:
measure: Focus Group Analysis (Aim I)
timeFrame: During focus participation, an average of 1-1.5 hours
measure: Improvement in Lung Cancer Screening Knowledge (LKS), According to Pre- vs. Post-intervention Scores (Aim II)
timeFrame: During shared decision-making participation, an average of 1 hour
measure: Decision of Cancer Screening (DCS) (Aim II)
timeFrame: During shared decision-making participation, an average of 1 hour
measure: Acceptability of Intervention Measure (AIM) (Aim II)
timeFrame: During shared decision-making participation, an average of 1 hour
measure: Fidelity (Aim II)
timeFrame: During shared decision-making participation, an average of 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Fred Hutch/University of Washington Cancer Consortium
state: Washington
Study officials:
affiliation: Fred Hutch/University of Washington Cancer Consortium
name: Matthew Triplette, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: