An observational study in Lung Carcinoma, sponsored by Fred Hutchinson Cancer Center. Completed at 1 site in United States. Open to participants aged 50 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-05-06.
Sponsored by Fred Hutchinson Cancer Center · Observational
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.
7,243 studies on the registry are indexed under Lung Neoplasms; 1,558 are open to participants now.
This study's enrollment of 102 is below the median of 189 across 1,512 observational studies indexed under Lung Neoplasms.
Browse Lung Neoplasms studies →Fred Hutchinson Cancer Center is the lead sponsor of 537 studies on the registry; 79 are open to participants now.
Of its 57 completed or terminated interventional studies of FDA-regulated products, 45 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
PWH enrolled in the local University of Washington (UW) HIV cohort and primary providers at Madison Clinic
Exclusion Criteria:
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 · Other: Discussion (focus group) · Other: Discussion (feedback on SDM) · Other: Interview · Other: Survey Administration
Receive SDM intervention
Also known as: Behavior Conditioning Therapy, Behavior Modification, Behavior or Life Style Modifications, Behavior Therapy, Behavioral Interventions, Behavioral Modification, Behavioral Therapy, Behavioral Treatment, Behavioral Treatments
Attend focus group
Also known as: Discuss
Provide feedback on SDM
Also known as: Discuss
Attend a telephone interview
Ancillary studies
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
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
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
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
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
| Milestone | Observational |
|---|---|
| Started | 102 |
| Completed | 40 |
| Not completed | 62 |
| Withdrew: Participant enrolled in aim i only. | 60 |
| Withdrew: Death | 2 |
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.
| Participants | Aims I-II |
|---|---|
| Focus Group Analysis (Aim I) | 43 |
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.
| score on a scale | Aims I-II |
|---|---|
| LCS-12 | 2.8 (2.1 to 3.5) |
| LKS-7 | 1.1 (0.6 to 1.6) |
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.
| score on a scale | Aims I-II |
|---|---|
| Decision of Cancer Screening (DCS) (Aim II) | 0 (0 to 5) |
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.
| score on a scale | Aims I-II |
|---|---|
| Acceptability of Intervention Measure (AIM) (Aim II) | 4.1 (4 to 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.
| percentage of completion | Aims I-II |
|---|---|
| Fidelity (Aim II) | 100 (97.5 to 100) |
Collected over Up to 1.5 years after participant enrollment.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Aims I-II | 3/102 (2.9%) | 0/102 (0%) | 0/102 (0%) |
| Age, Continuous(years) | Aims I-II |
|---|---|
| Median | 58.5 (55 to 63) |
| Sex: Female, Male(Participants) | Aims I-II |
|---|---|
| Female | 20 |
| Male | 82 |
| Race/Ethnicity, Customized(Participants) | Aims I-II |
|---|---|
| Race — White | 74 |
| Race — Black or African American | 9 |
| Race — American Indian or Alaska Native | 1 |
| Race — Asian | 4 |
| Race — Native Hawaiian or Pacific Islander | 0 |
| Race — More than one race | 9 |
| Race — Other race -- described as Hispanic or Latinx | 5 |
| Region of Enrollment(Participants) | Aims I-II |
|---|---|
| United States | 102 |
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Fred Hutchinson Cancer Center