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

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ClinicalTrials.gov Identifier: NCT03077230
Recruitment Status : Completed
First Posted : March 10, 2017
Last Update Posted : September 20, 2017
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Lung Neoplasms Early Detection of Cancer Decision Support Techniques Primary Health Care Behavioral: Pre/Post Test of a Lung Cancer Screening Decision Aid Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 62 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Pre-Post Study for Supporting Appropriate Implementation of Lung Cancer Screening
Study Start Date : May 2015
Actual Primary Completion Date : April 2017
Actual Study Completion Date : April 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
Experimental: Pre/Post Test of a Lung Cancer Screening Decision Aid 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.




Primary Outcome Measures :
  1. Change in decision-making measures of knowledge [ Time Frame: 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

  2. Change in screening attitudes [ Time Frame: 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.


  3. Change in decisional conflict [ Time Frame: 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.


  4. Change in screening intentions [ Time Frame: 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.



Secondary Outcome Measures :
  1. Preliminary estimates on the effect of the decision aid on behavioral outcomes [ Time Frame: 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.

  2. Feasibility of implementing a decision aid intervention in a primary care clinic setting [ Time Frame: 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.



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Ages Eligible for Study:   55 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03077230


Locations
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United States, North Carolina
UNC Ambulatory Care Center Internal Medicine Clinic
Chapel Hill, North Carolina, United States, 27599
Sponsors and Collaborators
UNC Lineberger Comprehensive Cancer Center
Investigators
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Principal Investigator: Daniel S Reuland, MD MPH University of North Carolina, Chapel Hill

Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: UNC Lineberger Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT03077230     History of Changes
Other Study ID Numbers: LCCC 1506
First Posted: March 10, 2017    Key Record Dates
Last Update Posted: September 20, 2017
Last Verified: September 2017
Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases