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

Not Applicable

Completed

• Conditions: Lung Neoplasms; Decision Support Techniques; Primary Health Care; Early Detection of Cancer
• Interventions: Behavioral: Pre/Post Test of a Lung Cancer Screening Decision Aid

• Registration Number: NCT03077230
• Lead Sponsor: UNC Lineberger Comprehensive Cancer Center

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.

Study Timeline

• Study Start: 2015-05
• Study First Submitted: 2016-11-22
• Study First Submitted QC: 2017-03-06
• Study First Posted: 2017-03-10
• Primary Completion: 2017-04
• Study Completion: 2017-04
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-19
• Last Update Posted: 2017-09-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pre/Post Test of a Lung Cancer Screening Decision Aid	Pre/Post Test of a Lung Cancer Screening Decision Aid	-

Primary Outcome Measures

Name	Time	Method
Change in screening intentions	At time of intervention	We 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.
Change in decision-making measures of knowledge	At time of intervention	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
Change in screening attitudes	At time of intervention	We 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 conflict	At time of intervention	We 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.

Secondary Outcome Measures

Name	Time	Method
Preliminary estimates on the effect of the decision aid on behavioral outcomes	Within 3 months of intervention	We 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 setting	Through study completion, an average of 1 year	This 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.

Trial Locations

Locations (1)

UNC Ambulatory Care Center Internal Medicine Clinic; 🇺🇸 Chapel Hill, North Carolina, United States