Clinical trial NCT03077230: Pre-Post Study for Supporting Appropriate Implementation of Lung Cancer Screening
Official title: Pre-Post Study for Supporting Appropriate Implementation of Lung Cancer Screening
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Neoplasms
Early Detection of Cancer
Decision Support Techniques
Primary Health Care
Lead sponsor: UNC Lineberger Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2017-03-10
Enrollment: 62
Sex: ALL
Minimum age (years): 55
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in decision-making measures of knowledge
timeFrame: At time of intervention
measure: Change in screening attitudes
timeFrame: At time of intervention
measure: Change in decisional conflict
timeFrame: At time of intervention
measure: Change in screening intentions
timeFrame: At time of intervention
Secondary outcomes:
measure: Preliminary estimates on the effect of the decision aid on behavioral outcomes
timeFrame: Within 3 months of intervention
measure: Feasibility of implementing a decision aid intervention in a primary care clinic setting
timeFrame: Through study completion, an average of 1 year
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: UNC Ambulatory Care Center Internal Medicine Clinic
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Daniel S Reuland, MD MPH
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
citation: 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.
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.
citation: 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.