Incorporating Veterans' Preferences Into Lung Cancer Screening Decisions

NCT02899754 | Completed Results

• 1 other identifier: IIR 15-143
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 3

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.

Conditions

Lung Cancer Screening

Keywords

lung cancer; decision support; implementation

Outcome Measures

Primary Outcomes (1)

• 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.

  1 month following the intervention

Secondary Outcomes (16)

• Decision Regret

  1 month following intervention

• Lung Cancer Knowledge

  Immediately Post Intervention, within 24 hours of intervention following the intervention

• Lung Cancer Screening Knowledge

  1 month post intervention

• Lung Cancer Screening Knowledge

  3 months post intervention

• Anxiety

  1 month following intervention

Study Arms (2)

Intervention Group

EXPERIMENTAL

Participants in this arm will use the lung cancer screening decision aid (LCSDecTool)

Behavioral: Lung Cancer Screening Decision Tool

Control Group

ACTIVE COMPARATOR

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.

Behavioral: Control Intervention

Interventions

Lung Cancer Screening Decision Tool BEHAVIORAL

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.

Also known as: LCSDecTool

Intervention Group

Control Intervention BEHAVIORAL

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.

Also known as: Control

Control Group

Eligibility Criteria

• Age: 55 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 55-80 years
• Enrolled in a Patient Aligned Care Team at a participating site
• or more pack years of smoking
• Active smoker or quit smoking within 15 years

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (3)

VA Connecticut Healthcare System West Haven Campus, West Haven, CT

West Haven, Connecticut, 06516, United States

Location

Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA

Philadelphia, Pennsylvania, 19104, United States

Location

Clement J. Zablocki VA Medical Center, Milwaukee, WI

Milwaukee, Wisconsin, 53295-1000, United States

Location

Related Publications (5)

• 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.

  PMID: 29736754 BACKGROUND

• 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.

  PMID: 35167781 BACKGROUND

• 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.

  PMID: 36255190 BACKGROUND

• 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.

  PMID: 33554740 RESULT

• 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.

  PMID: 37647070 RESULT

Related Links

• This website hosts lung cancer screening educational materials developed by the VA that will be used in the study

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Dr. Marilyn M Schapira, Senior Investigator, Center for Health Equity Research & Promotion (CHERP)
• Organization: Philadelphia VA Medical Center (CMCVAMC), Philadelphia, PA

mschap@pennmedicine.upenn.edu

215 898 2022

Study Officials

• Marilyn M. Schapira, MD MPH

  Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA

  PRINCIPAL INVESTIGATOR

• Jeffrey C Whittle, MD MPH

  Clement J. Zablocki VA Medical Center, Milwaukee, WI

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2016
• First Posted: September 14, 2016
• Study Start: January 28, 2019
• Primary Completion: November 30, 2021
• Study Completion: November 30, 2021
• Last Updated: November 14, 2024
• Results First Posted: November 14, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)