Clinical trial NCT02790866: Development and Feasibility Testing of a Lung Cancer Screening Decision Aid
Official title: Development and Feasibility Testing of a Lung Cancer Screening Decision Aid
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Neoplasms
Keywords: Decision Aid
Informed Decision Making
Shared Decision making
Screening
Lead sponsor: University of Kentucky
Sponsor class: OTHER
Collaborators: name: University of Miami
First posted: 2016-06-06
Enrollment: 50
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Access Rate POST
timeFrame: Two Weeks (POST)
measure: Recommendation Rate POST
timeFrame: Two Weeks (POST)
measure: Satisfaction Rate POST
timeFrame: Two Weeks (POST)
measure: Continued Access Rate POST
timeFrame: Two Weeks (POST)
measure: Retention Rate POST
timeFrame: Two Weeks (POST)
measure: Retention Rate FOL
timeFrame: Four Months (FOL)
Secondary outcomes:
measure: Recommendation Rate FOL
timeFrame: Four Months (FOL)
measure: Satisfaction Rate FOL
timeFrame: Four Months (FOL)
measure: Continued Access Rate FOL
timeFrame: Four Months (FOL)
measure: Access Rate FOL
timeFrame: Four Months (FOL)
Other outcomes:
measure: Contact Rate
timeFrame: Weekly from study initiation through 12 weeks
measure: Eligibility Rate
timeFrame: Weekly from study initiation through 12 weeks
measure: Accrual Rate
timeFrame: Weekly from study initiation through 12 weeks
Locations:
city: Miami
country: United States
facility: University of Miami (FL)
state: Florida
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
Study officials:
affiliation: University of Kentucky
name: Jamie L Studts, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Miami
name: Margaret M Byrne, PhD
role: PRINCIPAL_INVESTIGATOR
References: