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

Primary Purpose

Lung Neoplasms

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
LuCaS Decision Aid
NCI Website
Sponsored by
Jamie Studts
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Lung Neoplasms focused on measuring Decision Aid, Informed Decision Making, Shared Decision making, Screening

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Miami (FL)
  • University of Kentucky

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

LuCaS Decision Aid

NCI Website

Arm Description

Access to LuCaS, a web-based lung cancer screening decision aid

Access to NCI website on lung cancer screening

Outcomes

Primary Outcome Measures

Access Rate POST
Percentage of participants who access LuCaS Choices or National Cancer Institute (NCI) website
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
Satisfaction Rate POST
Percentage of participants who indicated they were satisfied with LuCaS Choices or National Cancer Institute (NCI) website
Continued Access Rate POST
Percentage of participants who wish to have continued access to LuCaS Choices or National Cancer Institute (NCI) website
Retention Rate POST
Percentage of participants who complete the POST survey
Retention Rate FOL
Percentage of participants who complete the FOL survey

Secondary Outcome Measures

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

Full Information

First Posted
May 16, 2016
Last Updated
April 1, 2019
Sponsor
Jamie Studts
Collaborators
University of Miami
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1. Study Identification

Unique Protocol Identification Number
NCT02790866
Brief Title
Development and Feasibility Testing of a Lung Cancer Screening Decision Aid
Acronym
LuCaS-DA
Official Title
Development and Feasibility Testing of a Lung Cancer Screening Decision Aid
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
March 2016 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jamie Studts
Collaborators
University of Miami

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Neoplasms
Keywords
Decision Aid, Informed Decision Making, Shared Decision making, Screening

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
LuCaS Decision Aid
Arm Type
Experimental
Arm Description
Access to LuCaS, a web-based lung cancer screening decision aid
Arm Title
NCI Website
Arm Type
Active Comparator
Arm Description
Access to NCI website on lung cancer screening
Intervention Type
Behavioral
Intervention Name(s)
LuCaS Decision Aid
Intervention Description
Web-based Lung Cancer Screening Decision Aid
Intervention Type
Behavioral
Intervention Name(s)
NCI Website
Intervention Description
NCI Website on Lung Cancer Screening
Primary Outcome Measure Information:
Title
Access Rate POST
Description
Percentage of participants who access LuCaS Choices or National Cancer Institute (NCI) website
Time Frame
Two Weeks (POST)
Title
Recommendation Rate POST
Description
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
Time Frame
Two Weeks (POST)
Title
Satisfaction Rate POST
Description
Percentage of participants who indicated they were satisfied with LuCaS Choices or National Cancer Institute (NCI) website
Time Frame
Two Weeks (POST)
Title
Continued Access Rate POST
Description
Percentage of participants who wish to have continued access to LuCaS Choices or National Cancer Institute (NCI) website
Time Frame
Two Weeks (POST)
Title
Retention Rate POST
Description
Percentage of participants who complete the POST survey
Time Frame
Two Weeks (POST)
Title
Retention Rate FOL
Description
Percentage of participants who complete the FOL survey
Time Frame
Four Months (FOL)
Secondary Outcome Measure Information:
Title
Recommendation Rate FOL
Description
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
Time Frame
Four Months (FOL)
Title
Satisfaction Rate FOL
Description
Percentage of participants who indicated they were satisfied with LuCaS Choices or National Cancer Institute (NCI) website
Time Frame
Four Months (FOL)
Title
Continued Access Rate FOL
Description
Percentage of participants who wish to have continued access to LuCaS Choices or National Cancer Institute (NCI) website
Time Frame
Four Months (FOL)
Title
Access Rate FOL
Description
Percentage of participants who access LuCaS Choices or National Cancer Institute (NCI) website
Time Frame
Four Months (FOL)
Other Pre-specified Outcome Measures:
Title
Contact Rate
Description
Number of individuals who make email or telephone contact to inquire about the study per week
Time Frame
Weekly from study initiation through 12 weeks
Title
Eligibility Rate
Description
Number of individuals who are determined to be study eligible
Time Frame
Weekly from study initiation through 12 weeks
Title
Accrual Rate
Description
Number of individuals who provide informed consent per week
Time Frame
Weekly from study initiation through 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jamie L Studts, PhD
Organizational Affiliation
University of Kentucky
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Margaret M Byrne, PhD
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Miami (FL)
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
University of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536-0086
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Development and Feasibility Testing of a Lung Cancer Screening Decision Aid

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