Lung CarcinomaNCT04682301
Tailoring Shared Decision Making for Lung Cancer Screening in Persons Living With HIV
An observational study of Lung Carcinoma, run by Fred Hutchinson Cancer Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lung Carcinoma
- What is being tested?
- Behavioral Intervention, Discussion (focus group) and Discussion (feedback on SDM)
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 102 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Feb 2021to 14 Mar 2023
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: PWH enrolled in the local University of Washington (UW) HIV cohort and primary providers at Madison Clinic
Who may be able to join
- 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
Who cannot join
- Those found to be ineligible for LCS on coordinator review
- Are non-English speaking or have cognitive dysfunction that would prevent participation in SDM
Trial locations and contacts
1 site in 1 country.
United States1 site
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, 98109
About this study
Official title: Tailoring Shared Decision Making for Lung Cancer Screening in Persons With HIV (PWH)
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.
Read the 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.
- Conditions
- Lung Carcinoma
- Being tested
- Behavioral Intervention, Discussion (focus group), Discussion (feedback on SDM), Interview, Survey Administration
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral InterventionBehavioural
Also called Behavior Conditioning Therapy, Behavior Modification, Behavior or Life Style Modifications, Behavior Therapy
Receive SDM intervention
Discussion (focus group)Other
Also called Discuss
Attend focus group
Discussion (feedback on SDM)Other
Also called Discuss
Provide feedback on SDM
InterviewOther
Attend a telephone interview
Survey AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Behavioral Intervention; Other: Discussion (focus group); Other: Discussion (feedback on SDM); Other: Interview; Other: Survey Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: During shared decision-making participation, an average of 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2020
- Study start5 Feb 2021
- Primary completion14 Mar 2023
- Study completion14 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lung CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fred Hutchinson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Matthew Triplette, Fred Hutchinson Cancer Center
- Investigators
- Matthew Triplette, MD, MPH, Principal investigator, Fred Hutch/University of Washington Cancer Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04682301
- Sponsor's protocol ID
- RG1121165
- Other IDs
- NCI-2020-08393, 10557, P30CA015704
- Status last verified
- May 2024
- First submitted
- 9 Dec 2020
- Last updated
- 6 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Murphy NR, Crothers K, Snidarich M, Budak JZ, Brown MC, Weiner BJ, Giustini N, Caverly T, Durette K, DeCell K, Triplette M. The Use of a Tailored Decision Aid to Improve Understanding of Lung Cancer Screening in People With HIV. Chest. 2025 Jan;167(1):259-269. doi: 10.1016/j.chest.2024.07.147. Epub 2024 Jul 29.
PubMed 39084517
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tailoring Shared Decision Making for Lung Cancer Screening in Persons With HIV (PWH)
- ClinicalTrials.gov ID
- NCT04682301
- Acronym / sponsor ID
- RG1121165
- Conditions
- Lung Carcinoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Fred Hutchinson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 5 Feb 2021 (actual)
- Primary completion
- 14 Mar 2023 (actual)
- Study completion
- 14 Mar 2023 (actual)
- First posted
- 23 Dec 2020 (actual)
- Results
- Posted 6 May 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Aims I-II | – | Behavioral: Behavioral Intervention, Other: Discussion (focus group), Other: Discussion (feedback on SDM), Other: Interview, Other: Survey AdministrationAIM 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. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- PWH enrolled in the local University of Washington (UW) HIV cohort and primary providers at Madison Clinic
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Those found to be ineligible for LCS on coordinator review
- Are non-English speaking or have cognitive dysfunction that would prevent participation in SDM
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Behavioral InterventionAlso: Behavior Conditioning Therapy, Behavior Modification, Behavior or Life Style Modifications, Behavior TherapyReceive SDM intervention | Behavioural | Aims I-II |
| Discussion (focus group)Also: DiscussAttend focus group | Other | Aims I-II |
| Discussion (feedback on SDM)Also: DiscussProvide feedback on SDM | Other | Aims I-II |
| InterviewAttend a telephone interview | Other | Aims I-II |
| Survey AdministrationAncillary studies | Other | Aims I-II |
Primary outcome
Focus Group Analysis (Aim I)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39084517Murphy NR, Crothers K, Snidarich M, Budak JZ, Brown MC, Weiner BJ, Giustini N, Caverly T, Durette K, DeCell K, Triplette M. The Use of a Tailored Decision Aid to Improve Understanding of Lung Cancer Screening in People With HIV. Chest. 2025 Jan;167(1):259-269. doi: 10.1016/j.chest.2024.07.147. Epub 2024 Jul 29.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthew Triplette, MD, MPH principal investigator
Fred Hutch/University of Washington Cancer Consortium
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Carcinoma, run by Fred Hutchinson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Focus Group Analysis (Aim I) (time frame: During focus participation, an average of 1-1.5 hours). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04682301, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2024.