Weill Cornell Medicine
New York, 10065, United States
NCT Number: NCT07216144
This study will assess the impact of centralized outreach on lung cancer screening completion among individuals served by Federally Qualified Health Centers.
Interested in participating?
Request Info50 year–80 year
All sexes
Interventional
Not applicable
New York, 10065, United States
This will be a two-arm, parallel, pragmatic randomized controlled trial (RCT) to evaluate the effectiveness of a centralized patient outreach strategy in increasing lung cancer screening (LCS) completion among populations served by Federally Qualified Health Centers (FQHCs). This study will randomize individuals potentially eligible for LCS (50-80 years, current or past smokers) to receive centralized patient outreach in addition to usual care (outreach arm) and usual care alone (usual care arm). Individuals assigned to the outreach arm will receive centralized patient outreach from the Lung screening team through a letter followed by up to three attempts of telephone contact. Individuals assigned to the usual care arm will not receive any contact during the study period and the referral for LCS will be made at the treating physician's discretion.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Centralized patient outreach for lung cancer screening will be conducted by the lung screening team and will consist of a letter followed by telephone contact. One week following the mail invitation, a senior patient coordinator (SPC) will make telephone contact with individuals to pre-screen eligibility determination based on pack-year smoking history. Up to three telephone contact attempts will be made within two weeks.
Time frame: Within 15 months of randomization
Time frame: Within 15 months of randomization
Proportion of individuals with Lung-RADS 1, 2, 3, and 4
Time frame: Within 15 months of randomization
Proportion of individuals with incident findings on LDCT (including moderate to severe coronary artery calcification, lung-mediastinal findings, moderate to severe emphysema, and abdominal findings)
Time frame: Within 6 months after screening
Proportion of individuals receiving a biopsy or lung cancer treatment
Time frame: Within 15 months of randomization
Weill Medical College of Cornell University
Other
Centralized Lung Cancer Screening Engagement in At-Risk Populations (CLEAR)
Acronym: CLEAR
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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