Clinical trial NCT02286713: PCORI-CER-1306-03385 Informed Decisions About Lung Cancer Screening
Official title: Promoting Informed Decisions About Lung Cancer Screening: Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Cancer
Smoking Cessation
Tobacco Use Cessation
Keywords: Lung Cancer Screening
heavy smokers
state-based smoking cessation quitlines
patient decision aid
low-dose computed tomography
LDCT
standard educational information
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
First posted: 2014-11-10
Enrollment: 516
Sex: ALL
Minimum age (years): 55
Maximum age (years): 77
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Educational research study where goal is to test educational materials that help people make informed decisions about lung cancer screening.

Detailed description: This is the second phase of a larger project funded by the Patient-Centered Outcomes Research Institute to help heavy smokers make informed decisions about lung cancer screening with low-dose computed tomography (LDCT). The aim of this phase is to compare outcomes for promoting informed screening decisions about lung cancer screening in a randomized trial of patients who smoke recruited through state-based smoking cessation quitlines, where patients will be randomly assigned to the updated patient decision aid or to standard educational materials on lung cancer screening.

Eligibility criteria: Inclusion Criteria:

1. Men and women 55 to 77 years of age.
2. Participants must speak English.
3. Current smoker or quit smoking within the past 15 years.
4. At least a 30 pack-year smoking history.

Exclusion Criteria:

1) History of lung cancer.

Primary outcomes:
measure: Mean Value: Preparation for Decision Making© Scale
timeFrame: Assessment at 1-week follow-up.
measure: Mean Value: Informed Subscale of the Decisional Conflict Scale©
timeFrame: Assessment at 1-week follow-up.
measure: Mean Value: Values Clarity Subscale of the Decisional Conflict Scale©
timeFrame: Assessment at 1-week follow-up.
Secondary outcomes:
measure: Mean Value: Knowledge of Lung Cancer Screening
timeFrame: One week to 6 months, assessments at 1-week, 3-months and 6-months follow-up.
Other outcomes:
Locations:
city: Ridgeland
country: United States
facility: Information and Quality Healthcare (IQH)
state: Mississippi
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Robert Volk, PhD
role: STUDY_CHAIR
References:
citation: Volk RJ, Lowenstein LM, Leal VB, Escoto KH, Cantor SB, Munden RF, Rabius VA, Bailey L, Cinciripini PM, Lin H, Housten AJ, Luckett PG, Esparza A, Godoy MC, Bevers TB. Effect of a Patient Decision Aid on Lung Cancer Screening Decision-Making by Persons Who Smoke: A Randomized Clinical Trial. JAMA Netw Open. 2020 Jan 3;3(1):e1920362. doi: 10.1001/jamanetworkopen.2019.20362.
citation: Lowenstein LM, Escoto KH, Leal VB, Bailey L, Bevers TB, Cantor SB, Cinciripini PM, Jacobs LE, Esparza A, Godoy MC, Housten AJ, Lin H, Luckett P, Munden RF, Rabius V, Volk RJ. Randomized trial of a patient-centered decision aid for promoting informed decisions about lung cancer screening: Implementation of a PCORI study protocol and lessons learned. Contemp Clin Trials. 2018 Sep;72:26-34. doi: 10.1016/j.cct.2018.07.007. Epub 2018 Jul 20.