Development and Feasibility Testing of a Lung Cancer Screening Decision Aid

Study Overview
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Brief Summary
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This study evaluates the feasibility and acceptability of LuCaS Choices, a web-based decision aid designed to facilitate informed decision making about participation in lung cancer screening among individuals at high risk of lung cancer due to heavy cigarette smoking.

Detailed Description
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The proposed project will develop an innovative web-based decision aid (DA) to improve decision making for lung cancer screening (LCS) among individuals at high risk for lung cancer due to cigarette smoking. Recent National Lung Screening Trial (NLST) data demonstrated a 20% relative reduction in lung cancer mortality for low dose computed tomography screening as compared to chest X-ray among individuals at high lung cancer risk. Given that lung cancer is the leading cause of cancer death in the United States with an estimated 160,340 deaths predicted for 2012, the new data have reinvigorated interest in LCS. However, LCS carries substantial risks including a high false positive rate, over-diagnosis, adverse psychosocial consequences, and increased radiation exposure. Further, it is unknown whether LCS would reduce lung cancer mortality among individuals who smoke but do not meet NLST eligibility criteria. Therefore, there is currently no clear best choice for whether a given individual should be screened or not. Decisions about participating in LCS should be well informed and consistent with individual preferences. However, previous data indicate that individuals who do undergo LCS rarely have a thorough understanding of the risks or benefits. To address this rapidly emerging public health challenge, this research has developed a web-based decision aid (DA) to facilitate informed decision making regarding LCS in individuals at high risk for lung cancer (i.e., cigarette smokers), and will assess feasibility of DA administration and proposed methods for conducting a future randomized clinical trial (RCT) of DA effectiveness. The content of the DA will be based on the investigators previous studies exploring LCS decision making and other recent research. The specific aim of the currently proposed research are to conduct a feasibility trial of the DA among individuals at high risk of lung cancer due to heavy cigarette smoking. Investigators will recruit participants to assess feasibility of: 1) delivering the DA intervention in a community setting, and 2) conducting research procedures and assessment tools as planned for a future RCT.

Official Title
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Development and Feasibility Testing of a Lung Cancer Screening Decision Aid

Conditions
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Lung Neoplasms

Intervention / Treatment
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* Behavioral: LuCaS Decision Aid
* Behavioral: NCI Website


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: be at least 40 years of age history of 20 or more pack years of smoking ability to read and understand English must have a personal phone must have Internet access Exclusion Criteria: reporting or demonstrating significant psychological distress

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LuCaS Decision Aid<br>Access to LuCaS, a web-based lung cancer screening decision aid | Behavioral: LuCaS Decision Aid<br>* Web-based Lung Cancer Screening Decision Aid<br>|
| Active Comparator: NCI Website<br>Access to NCI website on lung cancer screening | Behavioral: NCI Website<br>* NCI Website on Lung Cancer Screening<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Access Rate POST | Percentage of participants who access LuCaS Choices or National Cancer Institute (NCI) website | Two Weeks (POST) | 
| Recommendation Rate POST | Percentage of participants who would recommend LuCaS Choices or National Cancer Institute (NCI) website to others who want to learn more about lung cancer screening | Two Weeks (POST) | 
| Satisfaction Rate POST | Percentage of participants who indicated they were satisfied with LuCaS Choices or National Cancer Institute (NCI) website | Two Weeks (POST) | 
| Continued Access Rate POST | Percentage of participants who wish to have continued access to LuCaS Choices or National Cancer Institute (NCI) website | Two Weeks (POST) | 
| Retention Rate POST | Percentage of participants who complete the POST survey | Two Weeks (POST) | 
| Retention Rate FOL | Percentage of participants who complete the FOL survey | Four Months (FOL) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recommendation Rate FOL | Percentage of participants who would recommend LuCaS Choices or National Cancer Institute (NCI) website to others who want to learn more about lung cancer screening | Four Months (FOL) | 
| Satisfaction Rate FOL | Percentage of participants who indicated they were satisfied with LuCaS Choices or National Cancer Institute (NCI) website | Four Months (FOL) | 
| Continued Access Rate FOL | Percentage of participants who wish to have continued access to LuCaS Choices or National Cancer Institute (NCI) website | Four Months (FOL) | 
| Access Rate FOL | Percentage of participants who access LuCaS Choices or National Cancer Institute (NCI) website | Four Months (FOL) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Decision Aid, Informed Decision Making, Shared Decision making, Screening