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Incorporating Veterans' Preferences Into Lung Cancer Screening Decisions

Incorporating Veterans Preferences Into Lung Cancer Screening Decisions

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02899754
Acronym
LCSDecTool
Enrollment
140
Registered
2016-09-14
Start date
2019-01-28
Completion date
2021-11-30
Last updated
2024-11-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Cancer Screening

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

BEHAVIORALLung 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.

BEHAVIORALControl 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.

Sponsors

VA Office of Research and Development
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
55 Years to 80 Years
Healthy volunteers
No

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

MeasureTime frameDescription
Decisional Conflict1 month following the interventionThe 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

MeasureTime frameDescription
Lung Cancer KnowledgeImmediately Post Intervention, within 24 hours of intervention following the interventionKnowledge 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 Knowledge1 month post interventionKnowledge 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.
Anxiety1 month following interventionState 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 Uptake6 months after the interventionDocumentation of receiving a lung cancer screening test by 6 months following the intervention. This was obtained by chart review.
Decision Regret1 month following interventionDecision 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 Worry1 month after the interventionLung cancer worry as measured by a 7 item scale with a range of scores from 3 (low worry) to 13 (high worry).
Decisional ConflictImmediately 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 Regret3 months post-interventionDecisional 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 Months9 monthsA documented lung cancer screening test completed within 9 months of the intervention obtained by chart review

Countries

United States

Participant flow

Participants by arm

ArmCount
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
Total140

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyLost to Follow-up79

Baseline characteristics

CharacteristicIntervention GroupControl GroupTotal
Age, Continuous64 years65.0 years64.0 years
Anxiety
Anxiety No
45 Participants48 Participants93 Participants
Anxiety
Anxiety Yes
24 Participants23 Participants47 Participants
Arthritis
Arthritis No
39 Participants36 Participants75 Participants
Arthritis
Arthritis Yes
30 Participants35 Participants65 Participants
Asthma
Asthma No
65 Participants68 Participants133 Participants
Asthma
Asthma Yes
4 Participants3 Participants7 Participants
Depression
Depression No
36 Participants43 Participants79 Participants
Depression
Depression Yes
33 Participants28 Participants61 Participants
Diabetes
Diabetes No
51 Participants48 Participants99 Participants
Diabetes
Diabetes Yes
18 Participants23 Participants41 Participants
Education
Four or more years of college or university
3 Participants6 Participants9 Participants
Education
Grade School
3 Participants1 Participants4 Participants
Education
High School
28 Participants24 Participants52 Participants
Education
Post-college graduate degree
2 Participants1 Participants3 Participants
Education
Some College or University
33 Participants39 Participants72 Participants
Emphysema
Emphysema No
55 Participants57 Participants112 Participants
Emphysema
Emphysema Yes
14 Participants14 Participants28 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
1 Participants3 Participants4 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
68 Participants68 Participants136 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Health Literacy66.0 units on a scale66.0 units on a scale66.0 units on a scale
Heart Disease
Heart Disease No
60 Participants54 Participants114 Participants
Heart Disease
Heart Disease Yes
9 Participants17 Participants26 Participants
Hypertension
Hypertension No
44 Participants47 Participants91 Participants
Hypertension
Hypertension Yes
25 Participants24 Participants49 Participants
Income
0-25,000
28 Participants15 Participants43 Participants
Income
>100.000
2 Participants3 Participants5 Participants
Income
>25,000 - 50.000
24 Participants32 Participants56 Participants
Income
>50.000 - 75,000
11 Participants9 Participants20 Participants
Income
>75.000 - 100.000
1 Participants3 Participants4 Participants
Income
Prefer not to say
3 Participants9 Participants12 Participants
Numeracy4.0 units on a scale5.0 units on a scale5.0 units on a scale
Post Traumatic Stress Syndrome
Post-Traumatic Stress Syndrome No
38 Participants40 Participants78 Participants
Post Traumatic Stress Syndrome
Post-Traumatic Stress Syndrome Yes
31 Participants31 Participants62 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
42 Participants33 Participants75 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
1 Participants2 Participants3 Participants
Race (NIH/OMB)
White
26 Participants36 Participants62 Participants
Region of Enrollment
United States
69 Participants71 Participants140 Participants
Sex: Female, Male
Female
8 Participants3 Participants11 Participants
Sex: Female, Male
Male
61 Participants68 Participants129 Participants
Smoking Pack Years40.8 Pack Years of Smoking46.0 Pack Years of Smoking44.2 Pack Years of Smoking

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 690 / 71
other
Total, other adverse events
0 / 690 / 71
serious
Total, serious adverse events
0 / 690 / 71

Outcome results

Primary

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.

ArmMeasureValue (MEAN)
Intervention GroupDecisional Conflict25.7 units on a scale
Control GroupDecisional Conflict29.9 units on a scale
Comparison: Primary outcome assessed at 1 month post-interventionp-value: 0.18t-test, 2 sided
Secondary

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.

ArmMeasureValue (MEAN)
Intervention GroupAnxiety37.2 units on a scale
Control GroupAnxiety35.2 units on a scale
p-value: 0.22t-test, 2 sided
Secondary

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.

ArmMeasureValue (MEAN)
Intervention GroupAnxiety33.5 units on a scale
Control GroupAnxiety32.8 units on a scale
Secondary

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.

ArmMeasureValue (MEAN)
Intervention GroupAnxiety36.6 Scores on the State Trait Anxiety Index
Control GroupAnxiety38.2 Scores on the State Trait Anxiety Index
Secondary

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.

ArmMeasureValue (MEAN)
Intervention GroupDecisional Conflict24.2 Scores on the decisional conflict scale
Control GroupDecisional Conflict27.5 Scores on the decisional conflict scale
Secondary

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.

ArmMeasureValue (MEAN)
Intervention GroupDecisional Conflict22.2 units on a scale
Control GroupDecisional Conflict31.1 units on a scale
Secondary

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.

ArmMeasureValue (MEAN)
Intervention GroupDecisional Regret32.6 Score on Decisional Regret Scale
Control GroupDecisional Regret34.5 Score on Decisional Regret Scale
Secondary

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

ArmMeasureValue (MEAN)
Intervention GroupDecisional Regret32.5 units on a scale
Control GroupDecisional Regret34.3 units on a scale
Secondary

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

ArmMeasureValue (MEAN)
Intervention GroupDecision Regret34.7 units on a scale
Control GroupDecision Regret32.2 units on a scale
Secondary

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

ArmMeasureValue (MEAN)
Intervention GroupLung Cancer Knowledge7.0 units on a scale
Control GroupLung Cancer Knowledge4.9 units on a scale
p-value: <0.01t-test, 2 sided
Secondary

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.

ArmMeasureValue (MEAN)
Intervention GroupLung Cancer Screening Knowledge6.2 units on a scale
Control GroupLung Cancer Screening Knowledge5.1 units on a scale
p-value: 0.01t-test, 2 sided
Secondary

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.

ArmMeasureValue (MEAN)
Intervention GroupLung Cancer Screening Knowledge6.3 units on a scale
Control GroupLung Cancer Screening Knowledge5.2 units on a scale
p-value: 0.02t-test, 2 sided
Secondary

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

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Intervention GroupLung Cancer Screening Uptake26 Participants
Control GroupLung Cancer Screening Uptake15 Participants
p-value: 0.18t-test, 2 sided
Secondary

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

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Intervention GroupLung Cancer Screening Uptake Within 9 Months31 Participants
Control GroupLung Cancer Screening Uptake Within 9 Months18 Participants
Comparison: chi-square testp-value: 0.01Chi-squared
Secondary

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.

ArmMeasureValue (MEAN)
Intervention GroupLung Cancer Worry6.3 units on a scale
Control GroupLung Cancer Worry6.3 units on a scale
p-value: 0.64t-test, 2 sided
Secondary

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.

ArmMeasureValue (MEAN)
Intervention GroupLung Cancer Worry5.9 units on a scale
Control GroupLung Cancer Worry6.4 units on a scale
Secondary

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.

ArmMeasureValue (MEAN)
Intervention GroupLung Cancer Worry5.4 units on a scale
Control GroupLung Cancer Worry5.9 units on a scale

Source: ClinicalTrials.gov · Data processed: Feb 8, 2026