Clinical trial NCT02899754: Incorporating Veterans' Preferences Into Lung Cancer Screening Decisions
Official title: Incorporating Veterans Preferences Into Lung Cancer Screening Decisions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Cancer Screening
Keywords: lung cancer
decision support
implementation
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2016-09-14
Enrollment: 140
Sex: ALL
Minimum age (years): 55
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Decisional Conflict
timeFrame: 1 month following the intervention
Secondary outcomes:
measure: Decision Regret
timeFrame: 1 month following intervention
measure: Lung Cancer Knowledge
timeFrame: Immediately Post Intervention, within 24 hours of intervention following the intervention
measure: Lung Cancer Screening Knowledge
timeFrame: 1 month post intervention
measure: Lung Cancer Screening Knowledge
timeFrame: 3 months post intervention
measure: Anxiety
timeFrame: 1 month following intervention
measure: Lung Cancer Screening Uptake
timeFrame: 6 months after the intervention
measure: Lung Cancer Screening Uptake Within 9 Months
timeFrame: 9 months
measure: Lung Cancer Worry
timeFrame: 1 month after the intervention
measure: Decisional Conflict
timeFrame: Immediately post-intervention-the same day as the intervention following the intervention.
measure: Decisional Conflict
timeFrame: 3 months post-intervention
measure: Decisional Regret
timeFrame: 3 months post-intervention
measure: Decisional Regret
timeFrame: Immediately post-intervention-the same day as the intervention following the intervention
measure: Anxiety
timeFrame: Immediately post-intervention-the same day as the intervention following the intervention
measure: Anxiety
timeFrame: 3 months post intervention
measure: Lung Cancer Worry
timeFrame: immediately post-intervention-the same day as the intervention following the intervention.
measure: Lung Cancer Worry
timeFrame: 3 months post-intervention
Other outcomes:
Locations:
city: West Haven
country: United States
facility: VA Connecticut Healthcare System West Haven Campus, West Haven, CT
state: Connecticut
city: Philadelphia
country: United States
facility: Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
state: Pennsylvania
city: Milwaukee
country: United States
facility: Clement J. Zablocki VA Medical Center, Milwaukee, WI
state: Wisconsin
Study officials:
affiliation: Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
name: Marilyn M. Schapira, MD MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Clement J. Zablocki VA Medical Center, Milwaukee, WI
name: Jeffrey C Whittle, MD MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schapira MM. The Conundrum and Challenge of Lung Cancer Screening Shared Decision-making Implementation. J Gen Intern Med. 2018 Jul;33(7):989-990. doi: 10.1007/s11606-018-4449-z. No abstract available.
citation: Kim RY, Rendle KA, Mitra N, Saia CA, Neslund-Dudas C, Greenlee RT, Burnett-Hartman AN, Honda SA, Simoff MJ, Schapira MM, Croswell JM, Meza R, Ritzwoller DP, Vachani A. Racial Disparities in Adherence to Annual Lung Cancer Screening and Recommended Follow-Up Care: A Multicenter Cohort Study. Ann Am Thorac Soc. 2022 Sep;19(9):1561-1569. doi: 10.1513/AnnalsATS.202111-1253OC.
citation: Schapira MM, Rendle KA. Rising to the De-escalation Challenge: Multilevel Change Needed to Align Clinical Practice with Cancer Screening Guidelines. Med Decis Making. 2022 Nov;42(8):1045-1047. doi: 10.1177/0272989X221125168. No abstract available.
citation: Schapira MM, Rodriguez KL, Chhatre S, Fraenkel L, Bastian LA, Kravetz JD, Asan O, Akers S, Vachani A, Prigge JM, Meline J, Ibarra JV, Corn B, Kaminstein D. When Is a Harm a Harm? Discordance between Patient and Medical Experts' Evaluation of Lung Cancer Screening Attributes. Med Decis Making. 2021 Apr;41(3):317-328. doi: 10.1177/0272989X20987221. Epub 2021 Feb 6.
citation: Schapira MM, Hubbard RA, Whittle J, Vachani A, Kaminstein D, Chhatre S, Rodriguez KL, Bastian LA, Kravetz JD, Asan O, Prigge JM, Meline J, Schrand S, Ibarra JV, Dye DA, Rieder JB, Frempong JO, Fraenkel L. Lung Cancer Screening Decision Aid Designed for a Primary Care Setting: A Randomized Clinical Trial. JAMA Netw Open. 2023 Aug 1;6(8):e2330452. doi: 10.1001/jamanetworkopen.2023.30452.