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Completed

NCT Number: NCT02790866

Development and Feasibility Testing of a Lung Cancer Screening Decision Aid

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.

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Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Miami (FL), Miami, Florida, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LuCaS Decision Aid

Behavioral

Web-based Lung Cancer Screening Decision Aid

NCI Website

Behavioral

NCI Website on Lung Cancer Screening

Primary outcomes

  1. Access Rate POST

    Time frame: Two Weeks (POST)

    Percentage of participants who access LuCaS Choices or National Cancer Institute (NCI) website

  2. Recommendation Rate POST

    Time frame: Two 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

  3. Satisfaction Rate POST

    Time frame: Two Weeks (POST)

    Percentage of participants who indicated they were satisfied with LuCaS Choices or National Cancer Institute (NCI) website

  4. Continued Access Rate POST

    Time frame: Two Weeks (POST)

    Percentage of participants who wish to have continued access to LuCaS Choices or National Cancer Institute (NCI) website

  5. Retention Rate POST

    Time frame: Two Weeks (POST)

    Percentage of participants who complete the POST survey

  6. Retention Rate FOL

    Time frame: Four Months (FOL)

    Percentage of participants who complete the FOL survey

Secondary outcomes

  1. Recommendation Rate FOL

    Time frame: Four 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

  2. Satisfaction Rate FOL

    Time frame: Four Months (FOL)

    Percentage of participants who indicated they were satisfied with LuCaS Choices or National Cancer Institute (NCI) website

  3. Continued Access Rate FOL

    Time frame: Four Months (FOL)

    Percentage of participants who wish to have continued access to LuCaS Choices or National Cancer Institute (NCI) website

  4. Access Rate FOL

    Time frame: Four Months (FOL)

    Percentage of participants who access LuCaS Choices or National Cancer Institute (NCI) website

Other outcomes

  1. Contact Rate

    Time frame: Weekly from study initiation through 12 weeks

    Number of individuals who make email or telephone contact to inquire about the study per week

  2. Eligibility Rate

    Time frame: Weekly from study initiation through 12 weeks

    Number of individuals who are determined to be study eligible

  3. Accrual Rate

    Time frame: Weekly from study initiation through 12 weeks

    Number of individuals who provide informed consent per week

Sponsors and collaborators

Lead sponsor

Jamie Studts

Other

Collaborators

  • University of Miami

Registry information

Acronym: LuCaS-DA

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Jun 6, 2016
Registry last updated
Apr 3, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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