NCT02790866

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 16, 2016

Completed
21 days until next milestone

First Posted

Study publicly available on registry

June 6, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

April 3, 2019

Status Verified

April 1, 2019

Enrollment Period

9 months

First QC Date

May 16, 2016

Last Update Submit

April 1, 2019

Conditions

Lung Neoplasms

Keywords

Decision AidInformed Decision MakingShared Decision makingScreening

Outcome Measures

Primary Outcomes (6)

  • 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 Outcomes (4)

  • Recommendation Rate FOL

    Four Months (FOL)

  • Satisfaction Rate FOL

    Four Months (FOL)

  • Continued Access Rate FOL

    Four Months (FOL)

  • Access Rate FOL

    Four Months (FOL)

Other Outcomes (3)

  • Contact Rate

    Weekly from study initiation through 12 weeks

  • Eligibility Rate

    Weekly from study initiation through 12 weeks

  • Accrual Rate

    Weekly from study initiation through 12 weeks

Study Arms (2)

LuCaS Decision Aid

EXPERIMENTAL

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

Behavioral: LuCaS Decision Aid

NCI Website

ACTIVE COMPARATOR

Access to NCI website on lung cancer screening

Behavioral: NCI Website

Interventions

LuCaS Decision AidBEHAVIORAL

Web-based Lung Cancer Screening Decision Aid

LuCaS Decision Aid
NCI WebsiteBEHAVIORAL

NCI Website on Lung Cancer Screening

NCI Website

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • reporting or demonstrating significant psychological distress

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Miami (FL)

Miami, Florida, 33136, United States

Location

University of Kentucky

Lexington, Kentucky, 40536-0086, United States

Location

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Jamie L Studts, PhD

    University of Kentucky

    PRINCIPAL INVESTIGATOR

  • Margaret M Byrne, PhD

    University of Miami

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

May 16, 2016

First Posted

June 6, 2016

Study Start

March 1, 2016

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

April 3, 2019

Record last verified: 2019-04

Locations

US(2)