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

Lung Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03077230
• Other study ID #: LCCC 1506
• Status: Completed
• Phase: N/A
• First received: November 22, 2016
• Last updated: September 19, 2017
• Start date: May 2015
• Est. completion date: April 2017

Study information

• Verified date: September 2017
• Source: UNC Lineberger Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: April 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• Pre/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.

Locations

Country	Name	City	State
United States	UNC Ambulatory Care Center Internal Medicine Clinic	Chapel Hill	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
UNC Lineberger Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

References & Publications (4)

Bach 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. — View Citation

Kovalchik 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. — View Citation

Moyer 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. — View Citation

National 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in decision-making measures of knowledge	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	At time of intervention
Primary	Change in screening attitudes	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.	At time of intervention
Primary	Change in decisional conflict	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.	At time of intervention
Primary	Change in screening intentions	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.	At time of intervention
Secondary	Preliminary estimates on the effect of the decision aid on behavioral outcomes	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.	Within 3 months of intervention
Secondary	Feasibility of implementing a decision aid intervention in a primary care clinic setting	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.	Through study completion, an average of 1 year

External Links

•   UNC Lineberger Home Page