Trial Outcomes & Findings for Tailoring Shared Decision Making for Lung Cancer Screening in Persons Living With HIV (NCT NCT04682301)

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

102 participants

Primary outcome timeframe

During focus participation, an average of 1-1.5 hours

Results posted on

2024-05-06

Participant Flow

Participant milestones

Participant milestones
Measure	Observational 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
Overall Study STARTED	102
Overall Study COMPLETED	40
Overall Study NOT COMPLETED	62

Reasons for withdrawal

Reasons for withdrawal
Measure	Observational 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
Overall Study Participant enrolled in Aim I only.	60
Overall Study Death	2

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Aims I-II n=102 Participants 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
Age, Continuous	58.5 years n=5 Participants
Sex: Female, Male Female	20 Participants n=5 Participants
Sex: Female, Male Male	82 Participants n=5 Participants
Race/Ethnicity, Customized Race · White	74 Participants n=5 Participants
Race/Ethnicity, Customized Race · Black or African American	9 Participants n=5 Participants
Race/Ethnicity, Customized Race · American Indian or Alaska Native	1 Participants n=5 Participants
Race/Ethnicity, Customized Race · Asian	4 Participants n=5 Participants
Race/Ethnicity, Customized Race · Native Hawaiian or Pacific Islander	0 Participants n=5 Participants
Race/Ethnicity, Customized Race · More than one race	9 Participants n=5 Participants
Race/Ethnicity, Customized Race · Other race -- described as Hispanic or Latinx	5 Participants n=5 Participants
Region of Enrollment United States	102 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Aims I-II n=102 Participants 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
Focus Group Analysis (Aim I)	43 Participants

PRIMARY outcome

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

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

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.

Outcome measures

Outcome measures
Measure	Aims I-II n=40 Participants 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
Improvement in Lung Cancer Screening Knowledge (LKS), According to Pre- vs. Post-intervention Scores (Aim II) LCS-12	2.8 score on a scale Interval 2.1 to 3.5
Improvement in Lung Cancer Screening Knowledge (LKS), According to Pre- vs. Post-intervention Scores (Aim II) LKS-7	1.1 score on a scale Interval 0.6 to 1.6

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Aims I-II n=40 Participants 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
Decision of Cancer Screening (DCS) (Aim II)	0 score on a scale Interval 0.0 to 5.0

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Aims I-II n=40 Participants 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
Acceptability of Intervention Measure (AIM) (Aim II)	4.1 score on a scale Interval 4.0 to 5.0

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Aims I-II n=40 Participants 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
Fidelity (Aim II)	100 percentage of completion Interval 97.5 to 100.0

Adverse Events

Aims I-II

Serious events: 0 serious events

Other events: 0 other events

Deaths: 3 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Madison Snidarich, Clinical Research Coordinator

Fred Hutchinson Cancer Center

Phone: 2066674589

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place