Development and Feasibility Testing of a Lung Cancer Screening Decision Aid (LuCaS-DA)

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.

Study Overview

• Status: Completed
• Conditions: Lung Neoplasms
• Intervention / Treatment: Behavioral: LuCaS Decision Aid; Behavioral: NCI Website

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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • University of Miami (FL)
  • Kentucky
    • Lexington, Kentucky, United States, 40536-0086
      • University of Kentucky

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: SCREENING
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: LuCaS Decision Aid; Access to LuCaS, a web-based lung cancer screening decision aid	Behavioral: LuCaS Decision Aid; Web-based Lung Cancer Screening Decision Aid
ACTIVE_COMPARATOR: NCI Website; Access to NCI website on lung cancer screening	Behavioral: NCI Website; NCI Website on Lung Cancer Screening

What is the study measuring?

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)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Eligibility Rate	Number of individuals who are determined to be study eligible	Weekly from study initiation through 12 weeks
Accrual Rate	Number of individuals who provide informed consent per week	Weekly from study initiation through 12 weeks

Collaborators and Investigators

• Sponsor: Jamie Studts
• Collaborators: University of Miami
• Investigators: Principal Investigator: Jamie L Studts, PhD, University of Kentucky; Principal Investigator: Margaret M Byrne, PhD, University of Miami

Study record dates

Study Major Dates

• Study Start: March 1, 2016
• Primary Completion (ACTUAL): December 1, 2016
• Study Completion (ACTUAL): December 1, 2016

Study Registration Dates

• First Submitted: May 16, 2016
• First Submitted That Met QC Criteria: May 31, 2016
• First Posted (ESTIMATE): June 6, 2016

Study Record Updates

• Last Update Posted (ACTUAL): April 3, 2019
• Last Update Submitted That Met QC Criteria: April 1, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: Screening; Decision Aid; Informed Decision Making; Shared Decision making
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: 15-0001-P1H