Lung Cancer ScreeningLCSDecToolNCT02899754
Incorporating Veterans' Preferences Into Lung Cancer Screening Decisions
A study testing Lung Cancer Screening Decision Tool in people with Lung Cancer Screening, run by VA Office of Research and Development at 3 sites in United States.
Trial summary
Veterans have a high risk of developing lung in comparison to general populations due to their older age and smoking history. Recent evidence indicates that lung cancer screening with low dose CT scan reduces lung cancer mortality among older heavy smokers. Read more about this study
- Who is it for?
- Ages 55 to 80 years
- Conditions the study is for
- Lung Cancer Screening
- What is being tested?
- Lung Cancer Screening Decision Tool
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 3 sitesUnited States
- Study dates
- 28 Jan 2019to 30 Nov 2021
- Phase
- Interventional
- 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 55 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 55-80 years
- Enrolled in a Patient Aligned Care Team at a participating site
- 30 or more pack years of smoking
- Active smoker or quit smoking within 15 years
Who cannot join
- Cognitive impairment as determined by clinical history
- Previous diagnosis of cancer with the exception of non-melanoma skin cancer and localized prostate cancer that is 1-year post-diagnosis
- Life expectancy of less than 2 years as indicated by chart review and conformation with PCPC
- Inability to speak English
- Active surveillance of Lung Nodule,
- Enrolled in CMCVAMC Lung Cancer Screening Program
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Clement J. Zablocki VA Medical Center, Milwaukee, WI
Milwaukee, Wisconsin, 53295-1000
Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
Philadelphia, Pennsylvania, 19104
VA Connecticut Healthcare System West Haven Campus, West Haven, CT
West Haven, Connecticut, 06516
About this study
Official title: Incorporating Veterans Preferences Into Lung Cancer Screening Decisions
Veterans have a high risk of developing lung in comparison to general populations due to their older age and smoking history. Recent evidence indicates that lung cancer screening with low dose CT scan reduces lung cancer mortality among older heavy smokers. However, the rates of false positive findings are high, requiring further testing and evaluation. The aims of this study were to 1) elicit patient and provider stakeholder input to inform the development of a lung cancer screening decision tool, 2) develop a web-based Lung Cancer Screening Decision Tool (LCSDecTool) that incorporates patient and provider input, and 3) conduct a RCT to evaluate LCSDecTool compared to usual care knowledge about LCS, decisional conflict and uptake of LCS.
The investigators hypothesized that the use of the LCSDecTool would decrease decisional conflict at 1 month. As a secondary outcome the investigators hypothesized that there would be a decrease in uptake of LCS in the LCDDecTool group compared with the control intervention due to increased awareness of harms associated with LCS. Additional secondary outcomes were LCS knowledge, decisional regret, anxiety, and lung cancer worry.
Read more
Veterans who were receiving primary care in a participating VA Medical Center, aged 55 to 80 years with a smoking history of at least 30 pack-years who were current smokers or had quit within the past 15 years were eligible to participate in the study.
Participants were asked to link on to a study website and were randomly assigned to the LCSDecTool or a control intervention website. Following use of the intervention, participants had a primary care visit. Patient reported outcomes were assessed immediately post intervention and at 1 and 3-months post intervention. LCS uptake was assessed at 6 months post-intervention.
Read the detailed description
Lung cancer is the leading cause of cancer deaths in the United States. Recent clinical trials provide evidence that screening with low dose CT scans will decrease lung cancer and all-cause mortality among older heavy smokers. Clinical guidelines have been issued with the USPSTF recommending annual screening from age 55 to 80 for those with 30 pack years or more of smoking or who quit less than 15 years ago. Evidence clearly delineates both the benefits (mortality reduction) and harms (false positives, follow-up testing, risk of invasive testing, and risk of overdiagnosis) of lung cancer screening. Preliminary data from an HSR\&D pilot grant finds that some Veterans are highly reluctant to enter the care pathway associated with lung cancer screening due to its potential harms. Additional preliminary data using Best Worst Scaling in older smokers demonstrate groups of patients who place greater importance on harms than benefit when considering lung cancer screening. Preference assessment methods can help Veterans to weigh benefits and harms, consider the clinical pathway they are entering, anticipate future health states, and communicate these values to their health care providers. Although basic educational tools to inform lung cancer decision-making have been developed, there is a lack of validated preference assessment tools that can be integrated into the clinical setting. Building upon preference assessment methods developed and validated in an HSR\&D pilot grant (PI-Schapira) and using a trans-disciplinary approach, this team is positioned to advance the science and practice of decision support for lung cancer screening in the Veteran population. The objectives of this study are to 1) elicit patient and provider stakeholder input to inform the development of a lung cancer screening decision tool, 2) develop a web based Lung Cancer Screening Decision Tool (LCSDecTool) that incorporates patient and provider input, and 3) evaluate the impact of the LCSDecTool compared to usual care on the decision process, clinical outcomes, and quality of life. The study will be conducted in 3 phases. In phase 1, mixed methods will be used to assess usability of preference assessment methods and perceived usefulness of a web based lung cancer screening decision support tool among patient and provider stakeholders. In phase 2, an interactive web based decision support program will be developed that incorporates preference assessment methods. In phase 3, a pilot RCT will be conduced to evaluate the efficacy of the web based decision support program. Outcomes evaluated will include decision quality as indicated by knowledge, decisional conflict, and decision regret; screening behavior, clinical outcomes as indicated by anxiety, and quality of life. The study was conducted across three VA sites; West Haven-VA in Connecticut, Corporal Michael J. Crescenz VA in Philadelphia, Pennsylvania, and the Zablocki VA in Milwaukee, WI. Results of this study will provide tools that can be used to integrate lung cancer screening into clinical practice at VA Medical Centers in a patient centered approach. Lung cancer screening is fundamentally different from existing screening paradigms in several respects; eligibility is defined by a behavior (smoking), a high rate of false positive findings is expected, and the target population is older with higher comorbidity than the target population for cervical, breast, or colorectal screening. Given these unique aspects of lung cancer screening, there is a critical need to develop and test tools for preference assessment and informed decision making that are applicable for the VA setting. The current proposal provides a mechanism to accomplish these goals. The Principal Investigator is working closely with the US Department of Veterans Affairs National Center for Health Promotion and Disease Prevention to integrate the tools and paradigm developed to primary care in the VA Medical Care System. The work builds directly upon a recently completed HSR\&D pilot support in the area of lung cancer and shared decision making.
- Conditions
- Lung Cancer Screening
- Being tested
- Lung Cancer Screening Decision Tool, Control Intervention
- Keywords
- lung cancer, decision support, implementation
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lung Cancer Screening Decision ToolBehavioural
Also called LCSDecTool
This will be a lung cancer screening decision support tool that is web based and provides patients with information about the potential benefits and harms associated with lung cancer screening and helps them to consider their personal values when making a decision about whether to initiate or continue with lung cancer screening.
Control InterventionBehavioural
Also called Control
This will be a health message regarding prevention and healthy behavior that is not related to lung cancer screening but delivered in a similar modality and taking approximately the same amount of time as the LCSDecTool.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Participants in this arm will use the lung cancer screening decision aid (LCSDecTool) Receives: Behavioral: Lung Cancer Screening Decision Tool |
| Control Group | Active comparator | Content that provides general information on disease prevention and health promotion unrelated to lung cancer. The information will be delivered on the same modality and take a similar amount of time to administer. Receives: Behavioral: Control Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decisional Conflict
The Decisional Conflict Scale is a 16-item scale with a value that ranges 0 (low decisional conflict) to 100 (high decisional conflict. The scale includes five subscales in the domains of uncertainty ( 3 items), Informed (3 items), Value Clarity (3 items), Support ( 3 items), and Effective DM (4 items).
Each item is scored from a 0 (strongly agree), 1 (agree), 2 (neither agree nor disagree), 3) (disagree) or 4 (strongly disagree). The total sore for the 16 items is calculated by a) summing scores, b) dividing by 16, c) multiplying by 25. Scores range from 0 (no decisional conflict) to 100 (extremely high decisional conflict).
For each subscale the scores are obtained by a) summing scores, b) dividing by the number of items in the subscale, c) multiplying by 25. Scores are interpreted as range from 0(low decisional conflict) to 100 (high decisional conflict) in the respective domains.
Measured: 1 month following the intervention
Secondary outcomes (16)
Decision Regret
Decision regret as measured by a 5-item Decision Regret scale that is patient reported. This score range is from 0 (low decisional regret) to 100 (high decisional regret).
Measured: 1 month following intervention
Lung Cancer Knowledge
Knowledge was measured with the 12-Item Brief Measures of Smokers Knowledge of Lung Cancer Screening Scale. The scores on this scale range from 0 (low level of knowledge) to 12 (high level of knowledge). Higher scores indicate a better outcome. Each correct response to an item is added to create the final score.
Measured: Immediately Post Intervention, within 24 hours of intervention following the intervention
Lung Cancer Screening Knowledge
Knowledge was measured with the 12-Item Brief Measures of Smokers Knowledge of Lung Cancer Screening Scale. The scores on this scale range from 0 (low level of knowledge) to 12 (high level of knowledge). Higher scores indicate a higher amount of knowledge. Higher scores are a better outcome. 1 point is given to each correct item. The points are added to provide the total score.
Measured: 1 month post intervention
Lung Cancer Screening Knowledge
Knowledge was measured with the 12-Item Brief Measures of Smokers Knowledge of Lung Cancer Screening Scale. The scores on this scale range from 0 (low level of knowledge) to 12 (high level of knowledge).
Measured: 3 months post intervention
Anxiety
State anxiety was measured on the State Trait Anxiety Index Scale using the State subscale. This measure included 20 items with a total score ranging from 20 (low anxiety) to 80 (high anxiety).
Measured: 1 month following intervention
Lung Cancer Screening Uptake
Documentation of receiving a lung cancer screening test by 6 months following the intervention. This was obtained by chart review.
Measured: 6 months after the intervention
Lung Cancer Screening Uptake Within 9 Months
A documented lung cancer screening test completed within 9 months of the intervention obtained by chart review
Measured: 9 months
Lung Cancer Worry
Lung cancer worry as measured by a 7 item scale with a range of scores from 3 (low worry) to 13 (high worry).
Measured: 1 month after the intervention
Decisional Conflict
Measured by the Decisional Conflict Scale a 16-item scale with scores from 0(low decisional conflict) to 100 (high decisional conflict).
Measured: Immediately post-intervention-the same day as the intervention following the intervention.
Decisional Conflict
Decisional conflict as measured by the 16 item decisional conflict scale scored from 0 (low decisional conflict) to 100 (high decisional conflict)
Measured: 3 months post-intervention
Decisional Regret
Decisional regret was measured on the Decisional Regret scale. This is a 5 time scale with scores ranging from 0 (low decisional regret) to 100 (high decisional regret).
Measured: 3 months post-intervention
Decisional Regret
Decisional regret was measured on a 5 point decisional regret scale with scores ranging from 0 (low regret) to 100 (high regret).
Measured: Immediately post-intervention-the same day as the intervention following the intervention
Anxiety
Trait anxiety was measured using the State Trait Anxiety Index. This is a 20 item measure with scores ranging from 20 (low anxiety) to 80 (high anxiety).
Measured: Immediately post-intervention-the same day as the intervention following the intervention
Anxiety
Anxiety was measured using the Trait items on the State Trait Anxiety Index with scores ranging from 20 (low anxiety) to 80 (high anxiety).
Measured: 3 months post intervention
Lung Cancer Worry
Lung cancer worry was measured on a 3 point scale with scores ranging from 3 (low worry) to 13 (high worry)
Measured: immediately post-intervention-the same day as the intervention following the intervention.
Lung Cancer Worry
Lung Cancer Worry was measured on a 3 item scale with scores ranging from 3(low worry) to 13 (high worry)
Measured: 3 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2016 (estimated)
- Study start28 Jan 2019
- Primary completion30 Nov 2021
- Study completion30 Nov 2021
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 (5)Papers the sponsor has linked to this study.
- Other trials for Lung Cancer ScreeningStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Marilyn M. Schapira, MD MPH, Principal investigator, Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PAJeffrey C Whittle, MD MPH, Principal investigator, Clement J. Zablocki VA Medical Center, Milwaukee, WI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02899754
- Sponsor's protocol ID
- IIR 15-143
- Acronym
- LCSDecTool
- Status last verified
- Nov 2024
- First submitted
- 9 Sep 2016
- Last updated
- 14 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: A Limited Dataset (LDS) will be created and shared pursuant to a Data Use Agreement (DUA) that indicates adherence to any applicable Informed Consent provisions, appropriately limits use of the dataset and prohibits the recipient from identifying or re-identifying (or taking steps to identify or re-identify) any individual whose data are included in the dataset. A De-identified, Anonymized Dataset will be created and shared. A limited coded dataset will be made available on our CMCVAMC research website that is publically available. The dataset will be housed on a server, administered by CHERP behind the VA firewall, access being granted only to those who apply directly to the principal investigator , provide the necessary assurances that they will not re-identify the data, and submit to a clearance by the CMCVAMC Privacy Officer
Publications
Schapira MM. The Conundrum and Challenge of Lung Cancer Screening Shared Decision-making Implementation. J Gen Intern Med. 2018 Jul;33(7):989-990. doi: 10.1007/s11606-018-4449-z. No abstract available.
PubMed 29736754Kim RY, Rendle KA, Mitra N, Saia CA, Neslund-Dudas C, Greenlee RT, Burnett-Hartman AN, Honda SA, Simoff MJ, Schapira MM, Croswell JM, Meza R, Ritzwoller DP, Vachani A. Racial Disparities in Adherence to Annual Lung Cancer Screening and Recommended Follow-Up Care: A Multicenter Cohort Study. Ann Am Thorac Soc. 2022 Sep;19(9):1561-1569. doi: 10.1513/AnnalsATS.202111-1253OC.
PubMed 35167781Schapira MM, Rendle KA. Rising to the De-escalation Challenge: Multilevel Change Needed to Align Clinical Practice with Cancer Screening Guidelines. Med Decis Making. 2022 Nov;42(8):1045-1047. doi: 10.1177/0272989X221125168. No abstract available.
PubMed 36255190Schapira MM, Rodriguez KL, Chhatre S, Fraenkel L, Bastian LA, Kravetz JD, Asan O, Akers S, Vachani A, Prigge JM, Meline J, Ibarra JV, Corn B, Kaminstein D. When Is a Harm a Harm? Discordance between Patient and Medical Experts' Evaluation of Lung Cancer Screening Attributes. Med Decis Making. 2021 Apr;41(3):317-328. doi: 10.1177/0272989X20987221. Epub 2021 Feb 6.
PubMed 33554740Schapira MM, Hubbard RA, Whittle J, Vachani A, Kaminstein D, Chhatre S, Rodriguez KL, Bastian LA, Kravetz JD, Asan O, Prigge JM, Meline J, Schrand S, Ibarra JV, Dye DA, Rieder JB, Frempong JO, Fraenkel L. Lung Cancer Screening Decision Aid Designed for a Primary Care Setting: A Randomized Clinical Trial. JAMA Netw Open. 2023 Aug 1;6(8):e2330452. doi: 10.1001/jamanetworkopen.2023.30452.
PubMed 37647070
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incorporating Veterans Preferences Into Lung Cancer Screening Decisions
- ClinicalTrials.gov ID
- NCT02899754
- Acronym / sponsor ID
- LCSDecTool / IIR 15-143
- Conditions
- Lung Cancer Screening
- Keywords
- lung cancer, decision support, implementation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 28 Jan 2019 (actual)
- Primary completion
- 30 Nov 2021 (actual)
- Study completion
- 30 Nov 2021 (actual)
- First posted
- 14 Sep 2016 (estimated)
- Results
- Posted 14 Nov 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Veterans have a high risk of developing lung in comparison to general populations due to their older age and smoking history. Recent evidence indicates that lung cancer screening with low dose CT scan reduces lung cancer mortality among older heavy smokers. However, the rates of false positive findings are high, requiring further testing and evaluation. The aims of this study were to 1) elicit patient and provider stakeholder input to inform the development of a lung cancer screening decision tool, 2) develop a web-based Lung Cancer Screening Decision Tool (LCSDecTool) that incorporates patient and provider input, and 3) conduct a RCT to evaluate LCSDecTool compared to usual care knowledge about LCS, decisional conflict and uptake of LCS.
The investigators hypothesized that the use of the LCSDecTool would decrease decisional conflict at 1 month. As a secondary outcome the investigators hypothesized that there would be a decrease in uptake of LCS in the LCDDecTool group compared with the control intervention due to increased awareness of harms associated with LCS. Additional secondary outcomes were LCS knowledge, decisional regret, anxiety, and lung cancer worry.
Veterans who were receiving primary care in a participating VA Medical Center, aged 55 to 80 years with a smoking history of at least 30 pack-years who were current smokers or had quit within the past 15 years were eligible to participate in the study.
Participants were asked to link on to a study website and were randomly assigned to the LCSDecTool or a control intervention website. Following use of the intervention, participants had a primary care visit. Patient reported outcomes were assessed immediately post intervention and at 1 and 3-months post intervention. LCS uptake was assessed at 6 months post-intervention.
Detailed description
Lung cancer is the leading cause of cancer deaths in the United States. Recent clinical trials provide evidence that screening with low dose CT scans will decrease lung cancer and all-cause mortality among older heavy smokers. Clinical guidelines have been issued with the USPSTF recommending annual screening from age 55 to 80 for those with 30 pack years or more of smoking or who quit less than 15 years ago. Evidence clearly delineates both the benefits (mortality reduction) and harms (false positives, follow-up testing, risk of invasive testing, and risk of overdiagnosis) of lung cancer screening. Preliminary data from an HSR\&D pilot grant finds that some Veterans are highly reluctant to enter the care pathway associated with lung cancer screening due to its potential harms. Additional preliminary data using Best Worst Scaling in older smokers demonstrate groups of patients who place greater importance on harms than benefit when considering lung cancer screening. Preference assessment methods can help Veterans to weigh benefits and harms, consider the clinical pathway they are entering, anticipate future health states, and communicate these values to their health care providers. Although basic educational tools to inform lung cancer decision-making have been developed, there is a lack of validated preference assessment tools that can be integrated into the clinical setting. Building upon preference assessment methods developed and validated in an HSR\&D pilot grant (PI-Schapira) and using a trans-disciplinary approach, this team is positioned to advance the science and practice of decision support for lung cancer screening in the Veteran population. The objectives of this study are to 1) elicit patient and provider stakeholder input to inform the development of a lung cancer screening decision tool, 2) develop a web based Lung Cancer Screening Decision Tool (LCSDecTool) that incorporates patient and provider input, and 3) evaluate the impact of the LCSDecTool compared to usual care on the decision process, clinical outcomes, and quality of life. The study will be conducted in 3 phases. In phase 1, mixed methods will be used to assess usability of preference assessment methods and perceived usefulness of a web based lung cancer screening decision support tool among patient and provider stakeholders. In phase 2, an interactive web based decision support program will be developed that incorporates preference assessment methods. In phase 3, a pilot RCT will be conduced to evaluate the efficacy of the web based decision support program. Outcomes evaluated will include decision quality as indicated by knowledge, decisional conflict, and decision regret; screening behavior, clinical outcomes as indicated by anxiety, and quality of life. The study was conducted across three VA sites; West Haven-VA in Connecticut, Corporal Michael J. Crescenz VA in Philadelphia, Pennsylvania, and the Zablocki VA in Milwaukee, WI. Results of this study will provide tools that can be used to integrate lung cancer screening into clinical practice at VA Medical Centers in a patient centered approach. Lung cancer screening is fundamentally different from existing screening paradigms in several respects; eligibility is defined by a behavior (smoking), a high rate of false positive findings is expected, and the target population is older with higher comorbidity than the target population for cervical, breast, or colorectal screening. Given these unique aspects of lung cancer screening, there is a critical need to develop and test tools for preference assessment and informed decision making that are applicable for the VA setting. The current proposal provides a mechanism to accomplish these goals. The Principal Investigator is working closely with the US Department of Veterans Affairs National Center for Health Promotion and Disease Prevention to integrate the tools and paradigm developed to primary care in the VA Medical Care System. The work builds directly upon a recently completed HSR\&D pilot support in the area of lung cancer and shared decision making.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Lung Cancer Screening Decision ToolParticipants in this arm will use the lung cancer screening decision aid (LCSDecTool) |
| Control Group | Active comparator | Behavioral: Control InterventionContent that provides general information on disease prevention and health promotion unrelated to lung cancer. The information will be delivered on the same modality and take a similar amount of time to administer. |
Who may qualify
- Ages
- 55 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 55-80 years
- Enrolled in a Patient Aligned Care Team at a participating site
- 30 or more pack years of smoking
- Active smoker or quit smoking within 15 years
Key exclusion criteria (6 listed)
- Cognitive impairment as determined by clinical history
- Previous diagnosis of cancer with the exception of non-melanoma skin cancer and localized prostate cancer that is 1-year post-diagnosis
- Life expectancy of less than 2 years as indicated by chart review and conformation with PCPC
- Inability to speak English
- Active surveillance of Lung Nodule,
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 |
|---|---|---|
| Lung Cancer Screening Decision ToolAlso: LCSDecToolThis will be a lung cancer screening decision support tool that is web based and provides patients with information about the potential benefits and harms associated with lung cancer screening and helps them to consider their personal values when making a decision about whether to initiate or continue with lung cancer screening. | Behavioural | Intervention Group |
| Control InterventionAlso: ControlThis will be a health message regarding prevention and healthy behavior that is not related to lung cancer screening but delivered in a similar modality and taking approximately the same amount of time as the LCSDecTool. | Behavioural | Control Group |
Primary outcome
Decisional Conflict
Time frame: 1 month following the intervention
The Decisional Conflict Scale is a 16-item scale with a value that ranges 0 (low decisional conflict) to 100 (high decisional conflict. The scale includes five subscales in the domains of uncertainty ( 3 items), Informed (3 items), Value Clarity (3 items), Support ( 3 items), and Effective DM (4 items). Each item is scored from a 0 (strongly agree), 1 (agree), 2 (neither agree nor disagree), 3) (disagree) or 4 (strongly disagree). The total sore for the 16 items is calculated by a) summing scores, b) dividing by 16, c) multiplying by 25. Scores range from 0 (no decisional conflict) to 100 (extremely high decisional conflict). For each subscale the scores are obtained by a) summing scores, b) dividing by the number of items in the subscale, c) multiplying by 25. Scores are interpreted as range from 0(low decisional conflict) to 100 (high decisional conflict) in the respective domains.
16 secondary outcomes
Decision Regret
Time frame: 1 month following intervention
Lung Cancer Knowledge
Time frame: Immediately Post Intervention, within 24 hours of intervention following the intervention
Lung Cancer Screening Knowledge
Time frame: 1 month post intervention
Lung Cancer Screening Knowledge
Time frame: 3 months post intervention
Anxiety
Time frame: 1 month following intervention
Lung Cancer Screening Uptake
Time frame: 6 months after the intervention
Lung Cancer Screening Uptake Within 9 Months
Time frame: 9 months
Lung Cancer Worry
Time frame: 1 month after the intervention
Decisional Conflict
Time frame: Immediately post-intervention-the same day as the intervention following the intervention.
Decisional Conflict
Time frame: 3 months post-intervention
Decisional Regret
Time frame: 3 months post-intervention
Decisional Regret
Time frame: Immediately post-intervention-the same day as the intervention following the intervention
Anxiety
Time frame: Immediately post-intervention-the same day as the intervention following the intervention
Anxiety
Time frame: 3 months post intervention
Lung Cancer Worry
Time frame: immediately post-intervention-the same day as the intervention following the intervention.
Lung Cancer Worry
Time frame: 3 months post-intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 29736754Schapira MM. The Conundrum and Challenge of Lung Cancer Screening Shared Decision-making Implementation. J Gen Intern Med. 2018 Jul;33(7):989-990. doi: 10.1007/s11606-018-4449-z. No abstract available.
- Background: PubMed 35167781Kim RY, Rendle KA, Mitra N, Saia CA, Neslund-Dudas C, Greenlee RT, Burnett-Hartman AN, Honda SA, Simoff MJ, Schapira MM, Croswell JM, Meza R, Ritzwoller DP, Vachani A. Racial Disparities in Adherence to Annual Lung Cancer Screening and Recommended Follow-Up Care: A Multicenter Cohort Study. Ann Am Thorac Soc. 2022 Sep;19(9):1561-1569. doi: 10.1513/AnnalsATS.202111-1253OC.
- Background: PubMed 36255190Schapira MM, Rendle KA. Rising to the De-escalation Challenge: Multilevel Change Needed to Align Clinical Practice with Cancer Screening Guidelines. Med Decis Making. 2022 Nov;42(8):1045-1047. doi: 10.1177/0272989X221125168. No abstract available.
- Results publication: PubMed 33554740Schapira MM, Rodriguez KL, Chhatre S, Fraenkel L, Bastian LA, Kravetz JD, Asan O, Akers S, Vachani A, Prigge JM, Meline J, Ibarra JV, Corn B, Kaminstein D. When Is a Harm a Harm? Discordance between Patient and Medical Experts' Evaluation of Lung Cancer Screening Attributes. Med Decis Making. 2021 Apr;41(3):317-328. doi: 10.1177/0272989X20987221. Epub 2021 Feb 6.
- Results publication: PubMed 37647070Schapira MM, Hubbard RA, Whittle J, Vachani A, Kaminstein D, Chhatre S, Rodriguez KL, Bastian LA, Kravetz JD, Asan O, Prigge JM, Meline J, Schrand S, Ibarra JV, Dye DA, Rieder JB, Frempong JO, Fraenkel L. Lung Cancer Screening Decision Aid Designed for a Primary Care Setting: A Randomized Clinical Trial. JAMA Netw Open. 2023 Aug 1;6(8):e2330452. doi: 10.1001/jamanetworkopen.2023.30452.
- This website hosts lung cancer screening educational materials developed by the VA that will be used in the studyLink provided by the sponsor.
- Individual participant dataSharing planned: No. A Limited Dataset (LDS) will be created and shared pursuant to a Data Use Agreement (DUA) that indicates adherence to any applicable Informed Consent provisions, appropriately limits use of the dataset and prohibits the recipient from identifying or re-identifying (or taking steps to identify or re-identify) any individual whose data are included in the dataset. A De-identified, Anonymized Dataset will be created and shared. A limited coded dataset will be made available on our CMCVAMC research website that is publically available. The dataset will be housed on a server, administered by CHERP behind the VA firewall, access being granted only to those who apply directly to the principal investigator , provide the necessary assurances that they will not re-identify the data, and submit to a clearance by the CMCVAMC Privacy Officer
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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.
Marilyn M. Schapira, MD MPH principal investigator
Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
Jeffrey C Whittle, MD MPH principal investigator
Clement J. Zablocki VA Medical Center, Milwaukee, WI
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lung Cancer Screening Decision Tool in people with Lung Cancer Screening, run by VA Office of Research and Development at 3 sites 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 6 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 14 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 14 Nov 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?
Decisional Conflict (time frame: 1 month following the intervention). 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 NCT02899754, which also lists 5 linked publications.
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 14 Nov 2024.