Lung Cancer Screening
Conditions
Keywords
lung cancer, decision support, implementation
Brief 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. 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.
Interventions
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.
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.
Sponsors
Study design
Eligibility
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Decisional Conflict | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Lung Cancer Knowledge | Immediately Post Intervention, within 24 hours of intervention following the intervention | 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. |
| Lung Cancer Screening Knowledge | 1 month post intervention | 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. |
| Anxiety | 1 month following intervention | 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). |
| Lung Cancer Screening Uptake | 6 months after the intervention | Documentation of receiving a lung cancer screening test by 6 months following the intervention. This was obtained by chart review. |
| Decision Regret | 1 month following intervention | 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). |
| Lung Cancer Worry | 1 month after the intervention | Lung cancer worry as measured by a 7 item scale with a range of scores from 3 (low worry) to 13 (high worry). |
| Decisional Conflict | Immediately post-intervention-the same day as the intervention following the intervention. | Measured by the Decisional Conflict Scale a 16-item scale with scores from 0(low decisional conflict) to 100 (high decisional conflict). |
| Decisional Regret | 3 months post-intervention | 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). |
| Lung Cancer Screening Uptake Within 9 Months | 9 months | A documented lung cancer screening test completed within 9 months of the intervention obtained by chart review |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intervention Group Participants in this arm will use the lung cancer screening decision aid (LCSDecTool)
Lung Cancer Screening Decision Tool: 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. | 69 |
| Control Group 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.
Control Intervention: 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. | 71 |
| Total | 140 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 7 | 9 |
Baseline characteristics
| Characteristic | Intervention Group | Control Group | Total |
|---|---|---|---|
| Age, Continuous | 64 years | 65.0 years | 64.0 years |
| Anxiety Anxiety No | 45 Participants | 48 Participants | 93 Participants |
| Anxiety Anxiety Yes | 24 Participants | 23 Participants | 47 Participants |
| Arthritis Arthritis No | 39 Participants | 36 Participants | 75 Participants |
| Arthritis Arthritis Yes | 30 Participants | 35 Participants | 65 Participants |
| Asthma Asthma No | 65 Participants | 68 Participants | 133 Participants |
| Asthma Asthma Yes | 4 Participants | 3 Participants | 7 Participants |
| Depression Depression No | 36 Participants | 43 Participants | 79 Participants |
| Depression Depression Yes | 33 Participants | 28 Participants | 61 Participants |
| Diabetes Diabetes No | 51 Participants | 48 Participants | 99 Participants |
| Diabetes Diabetes Yes | 18 Participants | 23 Participants | 41 Participants |
| Education Four or more years of college or university | 3 Participants | 6 Participants | 9 Participants |
| Education Grade School | 3 Participants | 1 Participants | 4 Participants |
| Education High School | 28 Participants | 24 Participants | 52 Participants |
| Education Post-college graduate degree | 2 Participants | 1 Participants | 3 Participants |
| Education Some College or University | 33 Participants | 39 Participants | 72 Participants |
| Emphysema Emphysema No | 55 Participants | 57 Participants | 112 Participants |
| Emphysema Emphysema Yes | 14 Participants | 14 Participants | 28 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 3 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 68 Participants | 68 Participants | 136 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Health Literacy | 66.0 units on a scale | 66.0 units on a scale | 66.0 units on a scale |
| Heart Disease Heart Disease No | 60 Participants | 54 Participants | 114 Participants |
| Heart Disease Heart Disease Yes | 9 Participants | 17 Participants | 26 Participants |
| Hypertension Hypertension No | 44 Participants | 47 Participants | 91 Participants |
| Hypertension Hypertension Yes | 25 Participants | 24 Participants | 49 Participants |
| Income 0-25,000 | 28 Participants | 15 Participants | 43 Participants |
| Income >100.000 | 2 Participants | 3 Participants | 5 Participants |
| Income >25,000 - 50.000 | 24 Participants | 32 Participants | 56 Participants |
| Income >50.000 - 75,000 | 11 Participants | 9 Participants | 20 Participants |
| Income >75.000 - 100.000 | 1 Participants | 3 Participants | 4 Participants |
| Income Prefer not to say | 3 Participants | 9 Participants | 12 Participants |
| Numeracy | 4.0 units on a scale | 5.0 units on a scale | 5.0 units on a scale |
| Post Traumatic Stress Syndrome Post-Traumatic Stress Syndrome No | 38 Participants | 40 Participants | 78 Participants |
| Post Traumatic Stress Syndrome Post-Traumatic Stress Syndrome Yes | 31 Participants | 31 Participants | 62 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 42 Participants | 33 Participants | 75 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) White | 26 Participants | 36 Participants | 62 Participants |
| Region of Enrollment United States | 69 Participants | 71 Participants | 140 Participants |
| Sex: Female, Male Female | 8 Participants | 3 Participants | 11 Participants |
| Sex: Female, Male Male | 61 Participants | 68 Participants | 129 Participants |
| Smoking Pack Years | 40.8 Pack Years of Smoking | 46.0 Pack Years of Smoking | 44.2 Pack Years of Smoking |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 69 | 0 / 71 |
| other Total, other adverse events | 0 / 69 | 0 / 71 |
| serious Total, serious adverse events | 0 / 69 | 0 / 71 |
Outcome results
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
Population: There were 7 participants that were lost to follow-up at the 1 month visit in the experimental group and 9 participants that were lost to follow up at the 1 month visit in the control group.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intervention Group | Decisional Conflict | 25.7 units on a scale |
| Control Group | Decisional Conflict | 29.9 units on a scale |
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
Population: There were 7 participants in the experimental intervention group that were lost to follow up at the 1 month survey assessment and 9 participants in the control group that were lost to follow up at the 2 month survey assessment.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intervention Group | Anxiety | 37.2 units on a scale |
| Control Group | Anxiety | 35.2 units on a scale |
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
Population: There were 2 participants in the intervention group that did not complete the immediately post intervention survey and 2 participants in the control group that did not complete the immediately post-intervention survey.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intervention Group | Anxiety | 33.5 units on a scale |
| Control Group | Anxiety | 32.8 units on a scale |
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
Population: There were 9 participants in the intervention group that did not complete the 3 months follow up survey and 14 participants in the control group that did not complete the 3 months follow-up survey.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intervention Group | Anxiety | 36.6 Scores on the State Trait Anxiety Index |
| Control Group | Anxiety | 38.2 Scores on the State Trait Anxiety Index |
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
Population: There were 9 participants that were lost to follow-up at the 3 month survey assessment in the intervention group and 14 lost to follow-up at the 3 month assessment in the control group.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intervention Group | Decisional Conflict | 24.2 Scores on the decisional conflict scale |
| Control Group | Decisional Conflict | 27.5 Scores on the decisional conflict scale |
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.
Population: Two participants in the intervention group did not complete the immediately post-intervention survey and 2 participants in the control group did not complete the immediately post-intervention survey.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intervention Group | Decisional Conflict | 22.2 units on a scale |
| Control Group | Decisional Conflict | 31.1 units on a scale |
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
Population: There were 2 participants in the intervention group and 2 participants in the control group that did not complete the post-intervention survey when this outcome was ascertained.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intervention Group | Decisional Regret | 32.6 Score on Decisional Regret Scale |
| Control Group | Decisional Regret | 34.5 Score on Decisional Regret Scale |
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
Population: There were 9 participants lost to follow-up from the intervention group at the 3 month survey and 14 participants lost to follow-up in the intervention group at the 3 month survey
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intervention Group | Decisional Regret | 32.5 units on a scale |
| Control Group | Decisional Regret | 34.3 units on a scale |
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
Population: There were 7 participants that were lost to follow-up at the 1 month follow-up visit in experimental intervention group and 9 participants in the control group that were lost to follow up at the 1 month follow-up visit
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intervention Group | Decision Regret | 34.7 units on a scale |
| Control Group | Decision Regret | 32.2 units on a scale |
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
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intervention Group | Lung Cancer Knowledge | 7.0 units on a scale |
| Control Group | Lung Cancer Knowledge | 4.9 units on a scale |
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
Population: There were 9 participants in the experimental group that were lost to follow-up at the time of the 3 month survey and 14 participants in the control group that were lost to follow-up at the time of the 3 month survey.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intervention Group | Lung Cancer Screening Knowledge | 6.2 units on a scale |
| Control Group | Lung Cancer Screening Knowledge | 5.1 units on a scale |
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
Population: There were 7 participants that were lost to follow up at the time of the 1 month survey assessment for the experimental group and 9 participants lost to follow-up at the time of the 1 month survey assessment.in the control group.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intervention Group | Lung Cancer Screening Knowledge | 6.3 units on a scale |
| Control Group | Lung Cancer Screening Knowledge | 5.2 units on a scale |
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention Group | Lung Cancer Screening Uptake | 26 Participants |
| Control Group | Lung Cancer Screening Uptake | 15 Participants |
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention Group | Lung Cancer Screening Uptake Within 9 Months | 31 Participants |
| Control Group | Lung Cancer Screening Uptake Within 9 Months | 18 Participants |
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
Population: There were 7 participants in the experimental intervention group that were lost to follow-up at the 1 month survey and 9 participants in the control group that were lost to follow-up at the 1 month survey.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intervention Group | Lung Cancer Worry | 6.3 units on a scale |
| Control Group | Lung Cancer Worry | 6.3 units on a scale |
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.
Population: There were 2 participants in the intervention group and 2 participants in the control group that did not complete the immediately post-intervention survey.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intervention Group | Lung Cancer Worry | 5.9 units on a scale |
| Control Group | Lung Cancer Worry | 6.4 units on a scale |
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
Population: There were 9 participants in the intervention group and 14 participants in the control group that did not complete the 3 months post-intervention survey.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intervention Group | Lung Cancer Worry | 5.4 units on a scale |
| Control Group | Lung Cancer Worry | 5.9 units on a scale |