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Pre-Post Study for Supporting Appropriate Implementation of Lung Cancer Screening

Pre-Post Study for Supporting Appropriate Implementation of Lung Cancer Screening

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03077230
Enrollment
62
Registered
2017-03-10
Start date
2015-05-31
Completion date
2017-04-30
Last updated
2017-09-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Decision Support Techniques, Early Detection of Cancer, Lung Neoplasms, Primary Health Care

Brief summary

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.

Detailed description

Using a single group, pre-post design, we aim to assess the effect of the decision aid on screening knowledge, screening attitudes, decisional conflict, and screening intent within 3 months of decision aid viewing.

Interventions

BEHAVIORALPre/Post Test of a Lung Cancer Screening Decision Aid

After completing the baseline survey, the research team member will ask each participant asked to view the lung cancer screening decision aid on a tablet. The following areas regarding lung cancer screening: What is lung cancer?, Why is lung cancer a problem?, What is screening?, What is low-dose CT screening, Recommended frequency of screening, Screening factors, lung cancer risks and benefits (magnitude of benefit, harms, false positive, invasive procedures, radiation, stress/anxiety), Summary, Values Clarification, Screening Choice, and Smoking cessation messaging for current smokers OR positive reinforcement for former smokers.

Sponsors

UNC Lineberger Comprehensive Cancer Center
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
55 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in decision-making measures of knowledgeAt time of interventionWe 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
Change in screening attitudesAt time of interventionWe will use descriptive statistics to provide an overview of screening attitudes at baseline and at follow-up. • Exploratory: Using t-tests or chi-squared tests as appropriate, we will assess the change between baseline and follow-up of screening attitudes.
Change in decisional conflictAt time of interventionWe will use descriptive statistics to provide an overview of decisional conflict at baseline and at follow-up. • Exploratory: Using t-tests or chi-squared tests as appropriate, we will assess the change between baseline and follow-up of decisional conflict.
Change in screening intentionsAt time of interventionWe will use descriptive statistics to provide an overview of screening intentions at baseline and at follow-up. • Exploratory: Using t-tests or chi-squared tests as appropriate, we will assess the change between baseline and follow-up of screening intentions.

Secondary

MeasureTime frameDescription
Preliminary estimates on the effect of the decision aid on behavioral outcomesWithin 3 months of interventionWe will use descriptive statistics (means and proportions) to provide preliminary estimates on the effect of the decision aid on documentation of shared decision-making in the electronic health record and screening behavior at 3 months.
Feasibility of implementing a decision aid intervention in a primary care clinic settingThrough study completion, an average of 1 yearThis is a descriptive and qualitative aim. We will describe measures of feasibility related to time needed to complete surveys, participant ability to navigate decision aid website, number of times assistance is needed to complete surveys/navigate the decision aid website, and type of assistance required.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026