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Development and Feasibility Testing of a Lung Cancer Screening Decision Aid

Not Applicable
Completed
Conditions
Lung Neoplasms
Interventions
Behavioral: LuCaS Decision Aid
Behavioral: NCI Website
Registration Number
NCT02790866
Lead Sponsor
Jamie Studts
Brief Summary

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

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
50
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
LuCaS Decision AidLuCaS Decision AidAccess to LuCaS, a web-based lung cancer screening decision aid
NCI WebsiteNCI WebsiteAccess to NCI website on lung cancer screening
Primary Outcome Measures
NameTimeMethod
Retention Rate FOLFour Months (FOL)

Percentage of participants who complete the FOL survey

Satisfaction Rate POSTTwo Weeks (POST)

Percentage of participants who indicated they were satisfied with LuCaS Choices or National Cancer Institute (NCI) website

Access Rate POSTTwo Weeks (POST)

Percentage of participants who access LuCaS Choices or National Cancer Institute (NCI) website

Retention Rate POSTTwo Weeks (POST)

Percentage of participants who complete the POST survey

Recommendation Rate POSTTwo Weeks (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

Continued Access Rate POSTTwo Weeks (POST)

Percentage of participants who wish to have continued access to LuCaS Choices or National Cancer Institute (NCI) website

Secondary Outcome Measures
NameTimeMethod
Continued Access Rate FOLFour Months (FOL)

Percentage of participants who wish to have continued access to LuCaS Choices or National Cancer Institute (NCI) website

Satisfaction Rate FOLFour Months (FOL)

Percentage of participants who indicated they were satisfied with LuCaS Choices or National Cancer Institute (NCI) website

Access Rate FOLFour Months (FOL)

Percentage of participants who access LuCaS Choices or National Cancer Institute (NCI) website

Recommendation Rate FOLFour Months (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

Trial Locations

Locations (2)

University of Kentucky

🇺🇸

Lexington, Kentucky, United States

University of Miami (FL)

🇺🇸

Miami, Florida, United States

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