Tailoring Shared Decision Making for Lung Cancer Screening in Persons Living With HIV

NCT04682301 | Completed Results

• 4 other identifiers: RG1121165NCI-2020-0839310557P30CA015704
• Study Type: observational
• Target: 102
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Carcinoma

Outcome Measures

Primary Outcomes (5)

• Focus Group Analysis (Aim I)

  All focus groups will be recorded and transcribed. Will use a framework analysis approach which combines both inductive and deductive methods where generated themes are mapped onto an implementation framework, specifically the Tailored Implementation of Chronic Diseases (TICD) checklist. Codes will then be analyzed through a constant comparison method to determine key themes. Will analyze all focus groups in real time to make iterative changes to the focus group guide based on feedback and refining potential methods of shared decision making (SDM). Pre-/post-SDM survey data will be collected via tablet, with a paper option if desired. Effectively, number of participants who complete focus group participation for analysis.

  During focus participation, an average of 1-1.5 hours

• Improvement in Lung Cancer Screening Knowledge (LKS), According to Pre- vs. Post-intervention Scores (Aim II)

  The primary outcome was change in knowledge of LCS after using the tailored decision aid. We used two validated measures of LCS knowledge, the LCS-12 and LKS-7, to evaluate knowledge of risks, benefits, and characteristics of LCS. The LCS-12 includes twelve multiple-choice questions which assess knowledge of lung cancer risk, characteristics of LCS, and benefits and harms of LCS. The LKS-7 uses seven questions assessing understanding of the harms and benefits LCS, incidental findings, and the screening process. Our enrollment target was 40-50 patients to achieve greater than 90% power to observe a difference similar to a prior study in pre- and post-SDM knowledge of screening harms (69% to 93%). Minimum score of 0 for LCS-12 and LKS-7, indicating no improvement from pre- to post-intervention assessment on LCS knowledge; maximum score of 12 for LCS-12 and 7 for LKS-7. Higher score represents better outcome, or greater improvement from pre- to post-intervention on measures of LKS.

  During shared decision-making participation, an average of 1 hour

• Decision of Cancer Screening (DCS) (Aim II)

  The Decision of cancer screening (DCS) was used to evaluate participants' decisional conflict after SDM visits. The ten-item lower literacy DCS was selected with possible scores ranging from 0 (minimum; no decisional conflict) to 100 (maximum; extremely high decisional conflict), with possible sub-scores for resulting feelings of uncertainty, feeling informed, clarity of values regarding risks and benefits, and feeling supported. Each question has options for yes (0), unsure (2), and no (4); answers are summed, divided by ten, then multiplied by 25 to provide the overall DCS. Lower scores represent a better outcome, or no/low decisional conflict.

  During shared decision-making participation, an average of 1 hour

• Acceptability of Intervention Measure (AIM) (Aim II)

  The AIM was used to evaluate the acceptability of the intervention for participants. The AIM is a four-item measure to assess the acceptability of a given intervention, in this case the decision aid, producing responses on a scale from 1 (completely disagree) to 5 (completely agree) and higher scores indicating greater acceptability. The score is calculated by taking the mean of the four responses. Scores range from 1-5.

  During shared decision-making participation, an average of 1 hour

• Fidelity (Aim II)

  Fidelity summarized as median percent of a 10-item checklist completed. Higher percentages represented a better outcome, or greater fidelity to the intervention/completion of items throughout intervention. Minimum percentage of completion is 0; maximum percentage of completion is 100.

  During shared decision-making participation, an average of 1 hour

Study Arms (1)

Aims I-II

AIM I: Participants attend a focus group over 1-1.5 hours providing feedback on refining potential methods of 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.

Behavioral: Behavioral Intervention; Other: Discussion (focus group); Other: Discussion (feedback on SDM); Other: Interview; Other: Survey Administration

Interventions

Behavioral Intervention BEHAVIORAL

Receive SDM intervention

Also known as: Behavior Conditioning Therapy, Behavior Modification, Behavior or Life Style Modifications, Behavior Therapy, Behavioral Interventions, Behavioral Modification, Behavioral Therapy, Behavioral Treatment, Behavioral Treatments

Aims I-II

Discussion (focus group) OTHER

Attend focus group

Also known as: Discuss

Aims I-II

Discussion (feedback on SDM) OTHER

Provide feedback on SDM

Also known as: Discuss

Aims I-II

Interview OTHER

Attend a telephone interview

Aims I-II

Survey Administration OTHER

Ancillary studies

Aims I-II

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

PWH enrolled in the local University of Washington (UW) HIV cohort and primary providers at Madison Clinic

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Fred Hutchinson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

Location

Related Publications (1)

• Murphy NR, Crothers K, Snidarich M, Budak JZ, Brown MC, Weiner BJ, Giustini N, Caverly T, Durette K, DeCell K, Triplette M. The Use of a Tailored Decision Aid to Improve Understanding of Lung Cancer Screening in People With HIV. Chest. 2025 Jan;167(1):259-269. doi: 10.1016/j.chest.2024.07.147. Epub 2024 Jul 29.

  PMID: 39084517 DERIVED

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Behavior Therapy; Focus Groups; Interviews as Topic

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Limitations and Caveats

Limitations of this study are largely related to this being a pilot single-center study with no control arm. Additionally, it was implemented in a clinic already familiar with having regular SDM conversations regarding LCS which may limit generalizability to a primary care setting. Our study did not assess the durability of this improvement over weeks to months.

Results Point of Contact

• Title: Madison Snidarich, Clinical Research Coordinator
• Organization: Fred Hutchinson Cancer Center

msnidari@fredhutch.org

2066674589

Study Officials

• Matthew Triplette, MD, MPH

  Fred Hutch/University of Washington Cancer Consortium

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 9, 2020
• First Posted: December 23, 2020
• Study Start: February 5, 2021
• Primary Completion: March 14, 2023
• Study Completion: March 14, 2023
• Last Updated: May 6, 2024
• Results First Posted: May 6, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)