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

Sponsor
Fred Hutchinson Cancer Center (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT04682301
Collaborator
National Cancer Institute (NCI) (NIH)
263
1
31.8
8.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Behavioral Intervention
  • Other: Discussion (focus group)
  • Other: Discussion (feedback on SDM)
  • Other: Interview
  • Other: Survey Administration

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 Design

Study Type:
Observational
Anticipated Enrollment :
263 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Tailoring Shared Decision Making for Lung Cancer Screening in Persons Living With HIV (PLHIV)
Actual Study Start Date :
Feb 5, 2021
Anticipated Primary Completion Date :
Oct 1, 2023
Anticipated Study Completion Date :
Oct 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Observational (focus group, interview)

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
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

    Other: Survey Administration
    Ancillary studies

    Outcome Measures

    Primary Outcome Measures

    1. Focus group analysis (Aim I) [10 months]

      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.

    2. Lung cancer screening knowledge (LKS) responses (Aim II) [14 months]

      Pre- and post-intervention LKS responses will be compared via Chochran-Mantel-Haenszel or Friedman test based on data type. A Chochran-Mantel-Haenszel test will be used with categorical data and a Friedman test will be used with non-categorical data.

    3. Decision of cancer screening (DCS) (Aim II) [14 months]

      The DCS will be summarized as the median of scores for participants from 0 (extreme certainty) to 100 (extreme uncertainty).

    4. Acceptability of Intervention Measure (AIM) (Aim II) [14 months]

      Will be summarized and presented as range of scores from 1 (low acceptability/appropriateness) to 5 (high acceptability/appropriateness).

    5. Intervention Appropriateness Measure (Aim II) [14 months]

      Will be summarized and presented as range of scores from 1 (low acceptability/appropriateness) to 5 (high acceptability/appropriateness).

    6. Fidelity (Aim II) [14 months]

      Will be summarized as median percent of checklist items completed. Joint displays consistent with a mixed-methods convergent design will be used to analyze and interpret the data.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    50 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • AIM I: PLHIV enrolled in the local UW HIV cohort and primary providers at Madison Clinic

    • AIM I: Using proposed United States Preventive Services Task Force (USPSTF) guidelines, participants enrolled in the registry who are current or former smokers, and report >= 20 pack-years smoking history (n=165) will be eligible for recruitment

    • AIM I: Clinicians (medical doctors, physicians assistants and nurse practitioners) who provide primary care for PLHIV (n=48) will be eligible

    • AIM II: PLHIV 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Fred Hutch/University of Washington Cancer Consortium Seattle Washington United States 98109

    Sponsors and Collaborators

    • Fred Hutchinson Cancer Center
    • National Cancer Institute (NCI)

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Fred Hutchinson Cancer Center
    ClinicalTrials.gov Identifier:
    NCT04682301
    Other Study ID Numbers:
    • RG1121165
    • NCI-2020-08393
    • 10557
    • P30CA015704
    First Posted:
    Dec 23, 2020
    Last Update Posted:
    Mar 17, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Mar 17, 2022