Incorporating Veterans' Preferences Into Lung Cancer Screening Decisions

Not Applicable

Completed

• Conditions: Lung Cancer Screening
• Interventions: Behavioral: Control Intervention; Behavioral: Lung Cancer Screening Decision Tool

• Registration Number: NCT02899754
• Lead Sponsor: VA Office of Research and Development

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.

Study Timeline

• Study First Submitted: 2016-09-09
• Study First Submitted QC: 2016-09-09
• Study First Posted: 2016-09-14
• Study Start: 2019-01-28
• Primary Completion: 2021-11-30
• Study Completion: 2021-11-30
• Results First Submitted: 2023-03-21
• Status Verified: 2024-11
• Results First Submitted QC: 2024-11-08
• Last Update Submitted: 2024-11-08
• Results First Posted: 2024-11-14
• Last Update Posted: 2024-11-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group	Control Intervention	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.
Intervention Group	Lung Cancer Screening Decision Tool	Participants in this arm will use the lung cancer screening decision aid (LCSDecTool)

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 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	3 months 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).
Anxiety	3 months post intervention	Anxiety was measured using the Trait items on the State Trait Anxiety Index with scores 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.
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
Lung Cancer Worry	3 months post-intervention	Lung Cancer Worry was measured on a 3 item scale with scores ranging from 3(low worry) to 13 (high worry)
Decisional Conflict	3 months post-intervention	Decisional conflict as measured by the 16 item decisional conflict scale scored from 0 (low decisional conflict) to 100 (high decisional conflict)
Decisional Regret	Immediately post-intervention-the same day as the intervention following the intervention	Decisional regret was measured on a 5 point decisional regret scale with scores ranging from 0 (low regret) to 100 (high regret).

Trial Locations

Locations (3)

VA Connecticut Healthcare System West Haven Campus, West Haven, CT; 🇺🇸 West Haven, Connecticut, United States

Clement J. Zablocki VA Medical Center, Milwaukee, WI; 🇺🇸 Milwaukee, Wisconsin, United States

Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA; 🇺🇸 Philadelphia, Pennsylvania, United States