Centralized Lung Cancer Screening Engagement in At-Risk Populations
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Centralized patient outreach for lung cancer screening.
- Who it may be relevant to
- Registry conditions: Lung Cancer Screening. Basic parameters: 50 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Centralized Lung Cancer Screening Engagement in At-Risk Populations (CLEAR)
Overview
This study will assess the impact of centralized outreach on lung cancer screening completion among individuals served by Federally Qualified Health Centers.
Detailed description
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.
Interventions
- Behavioral Centralized patient outreach for lung cancer screening
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.
Primary outcome measures
- Proportion of individuals completing low-dose CT (LDCT) within 15 months of randomization. [Time frame: Within 15 months of randomization]
Secondary outcome measures (4)
- LDCT scan findings: Lung Imaging Reporting and Data System (Lung-RADS) [Time frame: Within 15 months of randomization]
- LDCT incident findings [Time frame: Within 15 months of randomization]
- Follow-up care [Time frame: Within 6 months after screening]
- Average costs of implementing centralized outreach per individual [Time frame: Within 15 months of randomization]
Eligibility criteria
Inclusion criteria
- Adults aged 50 to 80 years
- Current or past smokers
- Individuals without a recorded LDCT scan within the past year
- Individuals without a prior lung cancer diagnosis
- Active patients of Ryan Health
- Individuals with a mailing address in the New York City area and a phone number on file
Exclusion criteria
- Individuals aged less than 50 or above 80 years
- Individuals without smoking history
- Individuals with a recorded LDCT scan within the past year
- Individuals with a prior lung cancer diagnosis
- Individuals without a mailing address in the New York City area or a phone number on file
- Individuals served by one of Ryan Health clinics where the centralized patient outreach was developed
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Health services research
Study locations
United States · 1 center
- Weill Cornell Medicine — New York
Identifiers
NCT: NCT07216144 · 25-04028716