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N/A N=140 Randomized Single-blind Prevention

Incorporating Veterans' Preferences Into Lung Cancer Screening Decisions

Lung Cancer Screening

Enrolled (actual)
140
Serious AEs
0.0%
Results posted
Nov 2024
Primary outcome: Primary: Decisional Conflict — 25.7; 29.9 units on a scale — p=0.18

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Lung Cancer Screening Decision Tool (Behavioral); Control Intervention (Behavioral)
Age
Adult, Older Adult · 55+ yrs
Sex
All
Sponsor
VA Office of Research and Development
Primary completion
Nov 2021

Outcome Measures

OutcomeResultp-value
PRIMARY
Decisional Conflict
24.2; 27.5
SECONDARY
Decision Regret
34.7; 32.2
SECONDARY
Lung Cancer Knowledge
7.0; 4.9 <0.01 sig
SECONDARY
Lung Cancer Screening Knowledge
6.2; 5.1 0.01 sig
SECONDARY
Lung Cancer Screening Knowledge
6.2; 5.1 0.01 sig
SECONDARY
Anxiety
36.6; 38.2
SECONDARY
Lung Cancer Screening Uptake
26; 15 0.18
SECONDARY
Lung Cancer Screening Uptake Within 9 Months
31; 18 0.01 sig
SECONDARY
Lung Cancer Worry
5.4; 5.9
SECONDARY
Decisional Conflict
24.2; 27.5
SECONDARY
Decisional Conflict
24.2; 27.5
SECONDARY
Decisional Regret
32.6; 34.5
SECONDARY
Decisional Regret
32.6; 34.5
SECONDARY
Anxiety
36.6; 38.2
SECONDARY
Anxiety
36.6; 38.2
SECONDARY
Lung Cancer Worry
5.4; 5.9
SECONDARY
Lung Cancer Worry
5.4; 5.9

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.

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02899754). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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