Lung Carcinoma
Conditions
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.
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.
Interventions
BEHAVIORALBehavioral Intervention
Receive SDM intervention
OTHERDiscussion (focus group)
Attend focus group
OTHERDiscussion (feedback on SDM)
Provide feedback on SDM
OTHERInterview
Attend a telephone interview
OTHERSurvey Administration
Ancillary studies
Sponsors
National Cancer Institute (NCI)
Fred Hutchinson Cancer Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Focus Group Analysis (Aim I) | 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. |
| Improvement in Lung Cancer Screening Knowledge (LKS), According to Pre- vs. Post-intervention Scores (Aim II) | 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. |
| Decision of Cancer Screening (DCS) (Aim II) | 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. |
| Acceptability of Intervention Measure (AIM) (Aim II) | 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. |
| Fidelity (Aim II) | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
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 | 102 |
| Total | 102 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 2 |
| Overall Study | Participant enrolled in Aim I only. | 60 |
Baseline characteristics
| Characteristic | Aims I-II |
|---|---|
| Age, Continuous | 58.5 years |
| Race/Ethnicity, Customized Race American Indian or Alaska Native | 1 Participants |
| Race/Ethnicity, Customized Race Asian | 4 Participants |
| Race/Ethnicity, Customized Race Black or African American | 9 Participants |
| Race/Ethnicity, Customized Race More than one race | 9 Participants |
| Race/Ethnicity, Customized Race Native Hawaiian or Pacific Islander | 0 Participants |
| Race/Ethnicity, Customized Race Other race -- described as Hispanic or Latinx | 5 Participants |
| Race/Ethnicity, Customized Race White | 74 Participants |
| Region of Enrollment United States | 102 Participants |
| Sex: Female, Male Female | 20 Participants |
| Sex: Female, Male Male | 82 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 3 / 102 |
| other Total, other adverse events | 0 / 102 |
| serious Total, serious adverse events | 0 / 102 |
Outcome results
Primary
Acceptability of Intervention Measure (AIM) (Aim II)
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.
Time frame: During shared decision-making participation, an average of 1 hour
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Aims I-II | Acceptability of Intervention Measure (AIM) (Aim II) | 4.1 score on a scale |
Primary
Decision of Cancer Screening (DCS) (Aim II)
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.
Time frame: During shared decision-making participation, an average of 1 hour
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Aims I-II | Decision of Cancer Screening (DCS) (Aim II) | 0 score on a scale |
Primary
Fidelity (Aim II)
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.
Time frame: During shared decision-making participation, an average of 1 hour
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Aims I-II | Fidelity (Aim II) | 100 percentage of completion |
Primary
Focus Group Analysis (Aim I)
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.
Time frame: During focus participation, an average of 1-1.5 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Aims I-II | Focus Group Analysis (Aim I) | 43 Participants |
Primary
Improvement in Lung Cancer Screening Knowledge (LKS), According to Pre- vs. Post-intervention Scores (Aim II)
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Aims I-II | Improvement in Lung Cancer Screening Knowledge (LKS), According to Pre- vs. Post-intervention Scores (Aim II) | LCS-12 | 2.8 score on a scale |
| Aims I-II | Improvement in Lung Cancer Screening Knowledge (LKS), According to Pre- vs. Post-intervention Scores (Aim II) | LKS-7 | 1.1 score on a scale |