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Development and Feasibility Testing of a Lung Cancer Screening Decision Aid

Development and Feasibility Testing of a Lung Cancer Screening Decision Aid

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02790866
Acronym
LuCaS-DA
Enrollment
50
Registered
2016-06-06
Start date
2016-03-31
Completion date
2016-12-31
Last updated
2019-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Neoplasms

Keywords

Decision Aid, Informed Decision Making, Shared Decision making, Screening

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.

Interventions

BEHAVIORALLuCaS Decision Aid

Web-based Lung Cancer Screening Decision Aid

BEHAVIORALNCI Website

NCI Website on Lung Cancer Screening

Sponsors

University of Miami
CollaboratorOTHER
Jamie Studts
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
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
Retention Rate POSTTwo Weeks (POST)Percentage of participants who complete the POST survey
Retention Rate FOLFour Months (FOL)Percentage of participants who complete the FOL survey
Access Rate POSTTwo Weeks (POST)Percentage of participants who access LuCaS Choices or National Cancer Institute (NCI) website
Satisfaction Rate POSTTwo Weeks (POST)Percentage of participants who indicated they were satisfied with LuCaS Choices or National Cancer Institute (NCI) website
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

MeasureTime frameDescription
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
Satisfaction Rate FOLFour Months (FOL)Percentage of participants who indicated they were satisfied with LuCaS Choices or National Cancer Institute (NCI) website
Continued Access Rate FOLFour Months (FOL)Percentage of participants who wish to have continued access to LuCaS Choices or National Cancer Institute (NCI) website

Other

MeasureTime frameDescription
Contact RateWeekly from study initiation through 12 weeksNumber of individuals who make email or telephone contact to inquire about the study per week
Accrual RateWeekly from study initiation through 12 weeksNumber of individuals who provide informed consent per week
Eligibility RateWeekly from study initiation through 12 weeksNumber of individuals who are determined to be study eligible

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026