Lung Cancer Screening Decisions
Condition: Lung Cancer Screening
MeSH terms: Lung Neoplasms
Study type: Interventional

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.
      Preliminary studies report that while some Veterans are enthusiastic about screening, others
      are highly reluctant. Patient preferences should be considered as part of an informed
      decision making process for this emerging paradigm of lung cancer control. Effective methods
      for preference assessment among Veterans have not yet been developed, evaluated, and
      integrated into clinical practice. The specific aims 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.

      (5/8/18)-This project involves the recruitment of both Veterans as well as health care
      providers/leaders. Patient recruitment efforts at both sites will target male and female
      patients enrolled in a Patient Aligned Care Teams (PACT) who are eligible for lung cancer
      screening. Our recruitment goals for patients are 40% African American, 5% Hispanic patients,
      and 10% women.

      (10/25/2018) Patient recruitment efforts at both sites will target male and female To Date,
      32 Veterans have signed the consent form and completed their portion of the trial (16 at
      CMCVAMC and 16 at West Haven, CT). To Date, 61 Providers have completed their portion of the
      trial (18 at CMCVAMC and 43 at West Haven, CT). Enrollment for Phase 1 is complete.
      Enrollment for Phase 2 will begin in June, 2018.patients enrolled in a Patient Aligned Care
      Teams (PACT) who are eligible for lung cancer screening. Our recruitment goals for patients
      are 40% African American, 5% Hispanic patients, and 10% women. To Date, 9 Veterans have
      signed the consent form and completed their portion of the trial (9 at CMCVAMC and 0 at West
      Haven, CT). Enrollment for Phase 2 is ongoing with the intent to complete By November 30,
      2018.

      (01/15/2019) Phase 2 patient recruitment is complete. 18 Veterans have signed the consent
      form and completed their portion of the trial (12 at CMCVAMC and 6 at West Haven, CT). 14
      Providers have completed their portion of the trial (8 at CMCVAMC and 6 at West Haven, CT).
      Enrollment for Phase 3 will begin in February, 2019.

      To Date (7/1/2019) Enrollment for Phase 3 is ongoing with the intent to complete by February
      28, 2020. To Date, 18 Veterans have signed the consent form and completed their baseline
      portion of the trial (18 at CMCVAMC and 0 at West Haven, CT).

      To Date (12/3/2019) Enrollment for Phase 3 is ongoing with the intent to complete by February
      28, 2021. A 1-year study extension has been submitted and awaiting approval. To Date, 70
      Veterans have signed the consent form and completed their baseline portion of the trial (65
      at CMCVAMC and 5 at West Haven, CT).

      To Date (9/9/2020) Enrollment for Phase 3 has just resumed after being placed on
      administrative hold since March 2020 due to Covid-19. Secondary Site in West Haven, CT has
      been replaced by Milwaukee, WI. To Date, 90 Veterans have signed the consent form and
      completed their baseline portion of the trial (83 at CMCVAMC, 5 at West Haven, CT and 2 at
      Milwaukee, WI).

      To Date (2/16/2021) 9-Month Cost Extension was approved and study enrollment for Phase 3 will
      continue through September 2021. Due to COVID-19 and the increasing amounts of primary care
      telehealth appointments, both Philadelphia and Milwaukee have modified their protocols to
      include telephone baseline visits to meet our recruitment goals. To Date, 106 Veterans have
      signed the consent form and completed their baseline portion of the trial (91 at CMCVAMC, 5
      at West Haven, CT and 10 at Milwaukee, WI).

      To Date (12/02/2021) Recruitment has ended and 142 Veterans have signed the consent form and
      completed their baseline portion of the trial (107 at CMCVAMC, 5 at West Haven, CT and 29 at
      Milwaukee, WI). We are beginning our preliminary analysis.
    

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 will be
      conducted across two VA sites; West Haven-VA in Connecticut and Corporal Michael J. Crescenz
      VA in Philadelphia, Pennsylvania. 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.
    

Intervention name(s): Lung Cancer Screening Decision Tool; Control Intervention
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 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.
Other intervention name(s): LCSDecTool; Control
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: lung cancer; decision support; implementation