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

Primary Purpose

Lung Neoplasms, Early Detection of Cancer, Decision Support Techniques

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pre/Post Test of a Lung Cancer Screening Decision Aid
Sponsored by
UNC Lineberger Comprehensive Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Lung Neoplasms

Eligibility Criteria

55 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • UNC Ambulatory Care Center Internal Medicine Clinic

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Pre/Post Test of a Lung Cancer Screening Decision Aid

Arm Description

Outcomes

Primary Outcome Measures

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
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.
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.
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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
November 22, 2016
Last Updated
September 19, 2017
Sponsor
UNC Lineberger Comprehensive Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT03077230
Brief Title
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

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
May 2015 (undefined)
Primary Completion Date
April 2017 (Actual)
Study Completion Date
April 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UNC Lineberger Comprehensive Cancer Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Neoplasms, Early Detection of Cancer, Decision Support Techniques, Primary Health Care

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
62 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pre/Post Test of a Lung Cancer Screening Decision Aid
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Pre/Post Test of a Lung Cancer Screening Decision Aid
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in decision-making measures of knowledge
Description
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
Time Frame
At time of intervention
Title
Change in screening attitudes
Description
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.
Time Frame
At time of intervention
Title
Change in decisional conflict
Description
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.
Time Frame
At time of intervention
Title
Change in screening intentions
Description
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.
Time Frame
At time of intervention
Secondary Outcome Measure Information:
Title
Preliminary estimates on the effect of the decision aid on behavioral outcomes
Description
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.
Time Frame
Within 3 months of intervention
Title
Feasibility of implementing a decision aid intervention in a primary care clinic setting
Description
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.
Time Frame
Through study completion, an average of 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel S Reuland, MD MPH
Organizational Affiliation
University of North Carolina, Chapel Hill
Official's Role
Principal Investigator
Facility Information:
Facility Name
UNC Ambulatory Care Center Internal Medicine Clinic
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
21714641
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.
Results Reference
background
PubMed Identifier
23863051
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.
Results Reference
background
PubMed Identifier
22893040
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.
Results Reference
background
PubMed Identifier
24378917
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.
Results Reference
background
PubMed Identifier
29325548
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.
Results Reference
derived
Links:
URL
http://unclineberger.org
Description
UNC Lineberger Home Page

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

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