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

J

Jamie Studts

Status

Completed

Conditions

Lung Neoplasms

Treatments

Behavioral: NCI Website
Behavioral: LuCaS Decision Aid

Study type

Interventional

Funder types

Other

Identifiers

NCT02790866
15-0001-P1H

Details and patient eligibility

About

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.

Full 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.

Enrollment

50 patients

Sex

All

Ages

40+ years old

Volunteers

Accepts 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

Trial design

Primary purpose

Screening

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

50 participants in 2 patient groups

LuCaS Decision Aid
Experimental group
Description:
Access to LuCaS, a web-based lung cancer screening decision aid
Treatment:
Behavioral: LuCaS Decision Aid
NCI Website
Active Comparator group
Description:
Access to NCI website on lung cancer screening
Treatment:
Behavioral: NCI Website

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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