An interventional study of Lung Cancer Screening Decision Tool and Control Intervention in Lung Cancer Screening, sponsored by VA Office of Research and Development. Completed at 3 sites in United States. Open to participants aged 55 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-11-14.
Sponsored by VA Office of Research and Development · Not applicable, Interventional, and Prevention
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.
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.
7,334 studies on the registry are indexed under Lung Neoplasms; 1,554 are open to participants now.
This study's enrollment of 140 is above the median of 60 across 5,345 interventional studies indexed under Lung Neoplasms.
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Exclusion Criteria:
Participants in this arm will use the lung cancer screening decision aid (LCSDecTool)
Behavioral: Lung Cancer Screening Decision Tool
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.
Behavioral: Control Intervention
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.
Also known as: LCSDecTool
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.
Also known as: Control
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.
Time frame: 1 month following the intervention
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).
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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
Time frame: 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).
Time frame: 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).
Time frame: 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)
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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)
Time frame: 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)
Time frame: 3 months post-intervention
| Milestone | Intervention Group | Control Group |
|---|---|---|
| Started | 69 | 71 |
| Completed | 62 | 62 |
| Not completed | 7 | 9 |
| Withdrew: Lost to follow-up | 7 | 9 |
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.
| units on a scale | Intervention Group | Control Group |
|---|---|---|
| Decisional Conflict | 25.7 (21.4 to 30.1) | 29.9 (25.6 to 34.2) |
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).
| units on a scale | Intervention Group | Control Group |
|---|---|---|
| Decision Regret | 34.7 (32.2 to 37.2) | 32.2 (29.6 to 34.8) |
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.
| units on a scale | Intervention Group | Control Group |
|---|---|---|
| Lung Cancer Knowledge | 7.0 (6.3 to 7.7) | 4.9 (4.3 to 5.5) |
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.
| units on a scale | Intervention Group | Control Group |
|---|---|---|
| Lung Cancer Screening Knowledge | 6.3 (5.7 to 6.8) | 5.2 (4.5 to 5.8) |
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).
| units on a scale | Intervention Group | Control Group |
|---|---|---|
| Lung Cancer Screening Knowledge | 6.2 (5.6 to 6.8) | 5.1 (4.4 to 5.8) |
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).
| units on a scale | Intervention Group | Control Group |
|---|---|---|
| Anxiety | 37.2 (34.0 to 40.4) | 35.2 (31.3 to 39.0) |
Documentation of receiving a lung cancer screening test by 6 months following the intervention. This was obtained by chart review.
| Participants | Intervention Group | Control Group |
|---|---|---|
| Lung Cancer Screening Uptake | 26 | 15 |
A documented lung cancer screening test completed within 9 months of the intervention obtained by chart review
| Participants | Intervention Group | Control Group |
|---|---|---|
| Lung Cancer Screening Uptake Within 9 Months | 31 | 18 |
Lung cancer worry as measured by a 7 item scale with a range of scores from 3 (low worry) to 13 (high worry).
| units on a scale | Intervention Group | Control Group |
|---|---|---|
| Lung Cancer Worry | 6.3 (5.7 to 6.8) | 6.3 (5.7 to 7.0) |
Measured by the Decisional Conflict Scale a 16-item scale with scores from 0(low decisional conflict) to 100 (high decisional conflict).
| units on a scale | Intervention Group | Control Group |
|---|---|---|
| Decisional Conflict | 22.2 (18.3 to 26.0) | 31.1 (26.1 to 36.0) |
Decisional conflict as measured by the 16 item decisional conflict scale scored from 0 (low decisional conflict) to 100 (high decisional conflict)
| Scores on the decisional conflict scale | Intervention Group | Control Group |
|---|---|---|
| Decisional Conflict | 24.2 (20.8 to 27.6) | 27.5 (23.3 to 31.7) |
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).
| units on a scale | Intervention Group | Control Group |
|---|---|---|
| Decisional Regret | 32.5 (30.1 to 35.0) | 34.3 (31.9 to 36.7) |
Decisional regret was measured on a 5 point decisional regret scale with scores ranging from 0 (low regret) to 100 (high regret).
| Score on Decisional Regret Scale | Intervention Group | Control Group |
|---|---|---|
| Decisional Regret | 32.6 (30.1 to 35.1) | 34.5 (31.9 to 37.1) |
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).
| units on a scale | Intervention Group | Control Group |
|---|---|---|
| Anxiety | 33.5 (30.7 to 36.3) | 32.8 (29.8 to 35.9) |
Anxiety was measured using the Trait items on the State Trait Anxiety Index with scores ranging from 20 (low anxiety) to 80 (high anxiety).
| Scores on the State Trait Anxiety Index | Intervention Group | Control Group |
|---|---|---|
| Anxiety | 36.6 (33.6 to 39.7) | 38.2 (33.9 to 42.4) |
Lung cancer worry was measured on a 3 point scale with scores ranging from 3 (low worry) to 13 (high worry)
| units on a scale | Intervention Group | Control Group |
|---|---|---|
| Lung Cancer Worry | 5.9 (5.2 to 6.5) | 6.4 (5.9 to 6.9) |
Lung Cancer Worry was measured on a 3 item scale with scores ranging from 3(low worry) to 13 (high worry)
| units on a scale | Intervention Group | Control Group |
|---|---|---|
| Lung Cancer Worry | 5.4 (4.9 to 6.0) | 5.9 (5.3 to 6.6) |
Collected over The investigators monitored for adverse events from the date each patient was enrolled to 9 months following the completion of the each patients' intervention visit.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Intervention Group | 0/69 (0%) | 0/69 (0%) | 0/69 (0%) |
| Control Group | 0/71 (0%) | 0/71 (0%) | 0/71 (0%) |
| Age, Continuous(years) | Intervention Group | Control Group | Total |
|---|---|---|---|
| Median | 64 (61.0 to 69.0) | 65.0 (62.0 to 70.0) | 64.0 (61.0 to 69.0) |
| Sex: Female, Male(Participants) | Intervention Group | Control Group | Total |
|---|---|---|---|
| Female | 8 | 3 | 11 |
| Male | 61 | 68 | 129 |
| Ethnicity (NIH/OMB)(Participants) | Intervention Group | Control Group | Total |
|---|---|---|---|
| Hispanic or Latino | 1 | 3 | 4 |
| Not Hispanic or Latino | 68 | 68 | 136 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Intervention Group | Control Group | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 42 | 33 | 75 |
| White | 26 | 36 | 62 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 1 | 2 | 3 |
| Region of Enrollment(Participants) | Intervention Group | Control Group | Total |
|---|---|---|---|
| United States | 69 | 71 | 140 |
| Education(Participants) | Intervention Group | Control Group | Total |
|---|---|---|---|
| Grade School | 3 | 1 | 4 |
| High School | 28 | 24 | 52 |
| Some College or University | 33 | 39 | 72 |
| Four or more years of college or university | 3 | 6 | 9 |
| Post-college graduate degree | 2 | 1 | 3 |
| Income(Participants) | Intervention Group | Control Group | Total |
|---|---|---|---|
| 0-25,000 | 28 | 15 | 43 |
| >25,000 - 50.000 | 24 | 32 | 56 |
| >50.000 - 75,000 | 11 | 9 | 20 |
| >75.000 - 100.000 | 1 | 3 | 4 |
| >100.000 | 2 | 3 | 5 |
| Prefer not to say | 3 | 9 | 12 |
| Post Traumatic Stress Syndrome(Participants) | Intervention Group | Control Group | Total |
|---|---|---|---|
| Post-Traumatic Stress Syndrome Yes | 31 | 31 | 62 |
| Post-Traumatic Stress Syndrome No | 38 | 40 | 78 |
11 further baseline measures are reported on the registry.
Documents are hosted by the registry — open the source record to download them.
Plan to share: 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
Ran from Jan 2019 to primary completion in Nov 2021, 34 months.
Results were first posted in Nov 2024, 2 years 11 months after primary completion.
Of 774 non-industry interventional studies with no phase under Lung Neoplasms, half reached primary completion within 41 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 71. This study's 34 months is below that.
Counting every sponsor, half of 818 studies reached it within 39 months; a quarter within 17 and three quarters within 71.
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This study is completed, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
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