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Completed

NCT Number: NCT03077230

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

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.

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Key information

Conditions

Lung Neoplasms Decision Support Techniques Early Detection of Cancer Lung Diseases Neoplasms Neoplasms by Site Primary Health Care Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

55 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UNC Ambulatory Care Center Internal Medicine Clinic

Chapel Hill, North Carolina, 27599, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

UNC Lineberger Comprehensive Cancer Center

Other

Registry information

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Mar 10, 2017
Registry last updated
Sep 20, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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