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

NCT03077230 | Completed DMC

• 1 other identifier: LCCC 1506
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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 Outcomes (2)

• Preliminary estimates on the effect of the decision aid on behavioral outcomes

  Within 3 months of intervention

• Feasibility of implementing a decision aid intervention in a primary care clinic setting

  Through study completion, an average of 1 year

Study Arms (1)

Pre/Post Test of a Lung Cancer Screening Decision Aid

EXPERIMENTAL

Behavioral: Pre/Post Test of a Lung Cancer Screening Decision Aid

Interventions

Pre/Post Test of a Lung Cancer Screening Decision Aid BEHAVIORAL

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.

Pre/Post Test of a Lung Cancer Screening Decision Aid

Eligibility Criteria

• Age: 55 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• UNC Lineberger Comprehensive Cancer Center: lead

Study Sites (1)

UNC Ambulatory Care Center Internal Medicine Clinic

Chapel Hill, North Carolina, 27599, United States

Location

Related Publications (5)

• 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.

  PMID: 21714641 BACKGROUND

• 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.

  PMID: 23863051 BACKGROUND

• 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. doi: 10.7326/0003-4819-157-8-201210160-00524. No abstract available.

  PMID: 22893040 BACKGROUND

• 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.

  PMID: 24378917 BACKGROUND

• Reuland 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 DERIVED

Related Links

• UNC Lineberger Home Page

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Daniel S Reuland, MD MPH

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2016
• First Posted: March 10, 2017
• Study Start: May 1, 2015
• Primary Completion: April 1, 2017
• Study Completion: April 1, 2017
• Last Updated: September 20, 2017

Record last verified: 2017-09

Locations

US (1)