NCT04682301

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

Completed Results posted Last updated 6 May 2024

What this trial tests

trial testing Behavioral Intervention in Lung Carcinoma in 102 participants. Completed in 14 March 2023.

Timeline

5 February 2021

Primary endpoint
14 March 2023

14 March 2023

Quick facts

Lead sponsor	Fred Hutchinson Cancer Center
Status	Completed
Study type	OBSERVATIONAL
Enrollment	102
Start date	5 February 2021
Primary completion	14 March 2023
Estimated completion	14 March 2023
Sites	1 location across United States

Drugs / interventions tested

• Behavioral Intervention
• Discussion (focus group)
• Discussion (feedback on SDM)
• Interview
• Survey Administration

Conditions studied

• Lung Carcinoma — all drugs for Lung Carcinoma →

Sponsor

Fred Hutchinson Cancer Center — full company profile →

Who can join

50 and older, any sex, with Lung Carcinoma. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Focus Group Analysis (Aim I) Primary · 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 v

Group	Value	95% CI
Aims I-II	43

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

LCS-12

Group	Value	95% CI
Aims I-II	2.8	2.1 – 3.5

LKS-7

Group	Value	95% CI
Aims I-II	1.1	0.6 – 1.6

Decision of Cancer Screening (DCS) (Aim II) Primary · 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 repr

Group	Value	95% CI
Aims I-II	0	0 – 5

Acceptability of Intervention Measure (AIM) (Aim II) Primary · 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.

Group	Value	95% CI
Aims I-II	4.1	4 – 5

Fidelity (Aim II) Primary · 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.

Group	Value	95% CI
Aims I-II	100	97.5 – 100

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. The Use of a Tailored Decision Aid to Improve Understanding of Lung Cancer Screening in People With HIV.
   Murphy NR, Crothers K, Snidarich M, Budak JZ, et al · · 2025 · cited 4× · PMID 39084517 · DOI 10.1016/j.chest.2024.07.147