Clinical trial · Interventional
Pre-Post Study for Supporting Appropriate Implementation of Lung Cancer Screening
NCT03077230CI-TRIAL-00029607completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The primary objective of this study is to assess the effect of the decision aid on measures of decision-making such as knowledge, screening attitudes, decisional conflict, and screening intent.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Decision Support Techniques | — | UNRESOLVED | — |
| Early Detection of Cancer | — | UNRESOLVED | — |
| Lung Neoplasms | Lung Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Primary Health Care | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Pre/Post Test of a Lung Cancer Screening Decision Aid | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Pre/Post Test of a Lung Cancer Screening Decision Aid
- interventionNames
- Behavioral: Pre/Post Test of a Lung Cancer Screening Decision Aid
Primary outcomes (4)
- measure
- Change in decision-making measures of knowledge
- timeFrame
- At time of intervention
- description
- We will use descriptive statistics to provide an overview of knowledge at baseline and at follow-up. * Hypothesis 1: Screening specific knowledge will improve after completing the decision aid. o Statistical tests: * Overall knowledge: Treating knowledge as a continuous variable by adding number correct out of 12 items (0-12 possible points), we will perform a Wilcoxon sign rank test to assess change in knowledge between baseline and follow-up * Individual knowledge items: Using McNemar's test, we will compare the proportion who correctly answered individual knowledge items at baseline and follow-up
- measure
- Change in screening attitudes
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 55 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: Subjects must meet all of the following inclusion criteria to participate in this study: * Age 55 - 80; * Current smoker, or former smoker who has less than a 16-year quit history; * Have at least a 30-pack year smoking history (average packs per day \* years smoking); and * Patient of the Internal Medicine Clinic at University of North Carolina Health Care. Exclusion Criteria: All subjects meeting any of the following exclusion criteria at baseline will be excluded from study participation: * Ever diagnosed with lung cancer; * Undergone chemotherapy or radiation therapy in the past 18 months prior to enrollment; * Coughed up blood from lungs (also called hemoptysis) within the past year prior to enrollment; * Experienced unexplained weight loss of 15-pounds or more during six months prior to enrollment; and * Had a chest CT scan within the past 18 months prior to enrollment.
References
Publications (5)
- BACKGROUNDNational Lung Screening Trial Research Team; Aberle DR, Adams AM, Berg CD, Black WC, Clapp JD, Fagerstrom RM, Gareen IF, Gatsonis C, Marcus PM, Sicks JD. Reduced lung-cancer mortality with low-dose computed tomographic screening. N Engl J Med. 2011 Aug 4;365(5):395-409. doi: 10.1056/NEJMoa1102873. Epub 2011 Jun 29. PMID 21714641
- BACKGROUNDKovalchik SA, Tammemagi M, Berg CD, Caporaso NE, Riley TL, Korch M, Silvestri GA, Chaturvedi AK, Katki HA. Targeting of low-dose CT screening according to the risk of lung-cancer death. N Engl J Med. 2013 Jul 18;369(3):245-254. doi: 10.1056/NEJMoa1301851. PMID 23863051
- BACKGROUNDBach PB, Gould MK. When the average applies to no one: personalized decision making about potential benefits of lung cancer screening. Ann Intern Med. 2012 Oct 16;157(8):571-3. doi: 10.7326/0003-4819-157-8-201210160-00524. No abstract available. PMID 22893040
- BACKGROUNDMoyer VA; U.S. Preventive Services Task Force. Screening for lung cancer: U.S. Preventive Services Task Force recommendation statement. Ann Intern Med. 2014 Mar 4;160(5):330-8. doi: 10.7326/M13-2771. PMID 24378917
- DERIVEDReuland DS, Cubillos L, Brenner AT, Harris RP, Minish B, Pignone MP. A pre-post study testing a lung cancer screening decision aid in primary care. BMC Med Inform Decis Mak. 2018 Jan 12;18(1):5. doi: 10.1186/s12911-018-0582-1. PMID 29325548