Development and Feasibility Testing of a Lung Cancer Screening Decision Aid

Lung Neoplasms Clinical Trial

— LuCaS-DA  

Official title:

Development and Feasibility Testing of a Lung Cancer Screening Decision Aid

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02790866
• Other study ID #: 15-0001-P1H
• Status: Completed
• Phase: N/A
• Start date: March 2016
• Est. completion date: December 2016

Study information

• Verified date: April 2019
• Source: University of Kentucky
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lung Neoplasms

Intervention

Behavioral:
• LuCaS Decision Aid
Web-based Lung Cancer Screening Decision Aid
• NCI Website
NCI Website on Lung Cancer Screening

Locations

Country	Name	City	State
United States	University of Kentucky	Lexington	Kentucky
United States	University of Miami (FL)	Miami	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Jamie Studts	University of Miami

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Contact Rate	Number of individuals who make email or telephone contact to inquire about the study per week	Weekly from study initiation through 12 weeks
Other	Eligibility Rate	Number of individuals who are determined to be study eligible	Weekly from study initiation through 12 weeks
Other	Accrual Rate	Number of individuals who provide informed consent per week	Weekly from study initiation through 12 weeks
Primary	Access Rate POST	Percentage of participants who access LuCaS Choices or National Cancer Institute (NCI) website	Two Weeks (POST)
Primary	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)
Primary	Satisfaction Rate POST	Percentage of participants who indicated they were satisfied with LuCaS Choices or National Cancer Institute (NCI) website	Two Weeks (POST)
Primary	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)
Primary	Retention Rate POST	Percentage of participants who complete the POST survey	Two Weeks (POST)
Primary	Retention Rate FOL	Percentage of participants who complete the FOL survey	Four Months (FOL)
Secondary	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)
Secondary	Satisfaction Rate FOL	Percentage of participants who indicated they were satisfied with LuCaS Choices or National Cancer Institute (NCI) website	Four Months (FOL)
Secondary	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)
Secondary	Access Rate FOL	Percentage of participants who access LuCaS Choices or National Cancer Institute (NCI) website	Four Months (FOL)