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

May 2, 2024 updated by: Matthew Triplette, Fred Hutchinson Cancer Center

Tailoring Shared Decision Making for Lung Cancer Screening in Persons With HIV (PWH)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

102

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Washington
      • Seattle, Washington, United States, 98109
        • Fred Hutch/University of Washington Cancer Consortium

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Other: Survey Administration
Ancillary studies
Behavioral: Behavioral Intervention
Receive SDM intervention
Other Names:
  • Behavior Conditioning Therapy
  • Behavior Modification
  • Behavior or Life Style Modifications
  • Behavior Therapy
  • Behavioral Interventions
  • Behavioral Modification
  • Behavioral Therapy
  • Behavioral Treatment
  • Behavioral Treatments
Other: Discussion (focus group)
Attend focus group
Other Names:
  • Discuss
Other: Discussion (feedback on SDM)
Provide feedback on SDM
Other Names:
  • Discuss
Other: Interview
Attend a telephone interview

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Focus Group Analysis (Aim I)
Time Frame: During focus participation, an average of 1-1.5 hours

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)
Time Frame: During shared decision-making participation, an average of 1 hour
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)
Time Frame: During shared decision-making participation, an average of 1 hour
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)
Time Frame: During shared decision-making participation, an average of 1 hour

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)
Time Frame: During shared decision-making participation, an average of 1 hour
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fred Hutchinson Cancer Center

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Matthew Triplette, MD, MPH, Fred Hutch/University of Washington Cancer Consortium

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 5, 2021

Primary Completion (Actual)

March 14, 2023

Study Completion (Actual)

March 14, 2023

Study Registration Dates

First Submitted

December 9, 2020

First Submitted That Met QC Criteria

December 18, 2020

First Posted (Actual)

December 23, 2020

Study Record Updates

Last Update Posted (Actual)

May 6, 2024

Last Update Submitted That Met QC Criteria

May 2, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RG1121165
  • P30CA015704 (U.S. NIH Grant/Contract)
  • NCI-2020-08393 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
  • 10557 (Fred Hutch/University of Washington Cancer Consortium)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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