Neoplasms

All Conditions

Respiratory Tract (Lung and Bronchial) Diseases

Infections

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Immune System Diseases

Carcinoma

Lung Neoplasms

Acquired Immunodeficiency Syndrome

HIV Infections

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

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 Intervention

Discussion (focus group)

Discussion (feedback on SDM)

Interview

Survey Administration

Matthew Triplette, MD, MPH

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.

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.

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

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

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.

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.

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.

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.

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.

National Cancer Institute (NCI)

Fred Hutchinson Cancer Center

Associate Professor

Definition of adverse and serious adverse event do not vary from clinicaltrials.gov definition.

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 Intervention: Receive SDM intervention

Discussion (focus group): Attend focus group

Discussion (feedback on SDM): Provide feedback on SDM

Interview: Attend a telephone interview

Survey Administration: Ancillary studies

Aims I-II

Age, Continuous

Sex: Female, Male

Race

Race/Ethnicity, Customized

United States

Region of Enrollment

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.

Madison Snidarich, Clinical Research Coordinator

Focus Group Analysis (Aim I)

LCS-12

LKS-7

Includes subset of individuals who completed shared decision-making visit in interventional Aim only.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Tailoring Shared Decision Making for Lung Cancer Screening in Persons Living With HIV	NCT04682301	Lung Carcinoma	Behavioral Inte... Discussion (foc... Discussion (fee... Interview Survey Administ...	50 Years -	Fred Hutchinson Cancer Center
Tailoring Shared Decision Making for Lung Cancer Screening in Persons Living With HIV	NCT04682301	Lung Carcinoma	Behavioral Inte... Discussion (foc... Discussion (fee... Interview Survey Administ...	50 Years -	Fred Hutchinson Cancer Center

Spots Global Cancer Trial Database for discussion (focus group)