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Recruiting NCT06898333

Implementation and Effectiveness of the BJC-Pink and Pearl Project on Lung Cancer Screening

— Observational Lung Cancer Cancer of the Lung

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
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Lung Cancer, Cancer of the Lung. Basic parameters: from 18 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 →

Unsure about the terms? Read our patient guide →

Official title

Evaluating the Implementation and Effectiveness of the BJC-Pink and Pearl Project on Lung Cancer Screening

Overview

The investigators proposal is ripe for executing as the investigators seek to leverage this "natural experiment" initiated by the BJC health system to evaluate the effectiveness of the Pink \& Pearl Campaign as an implementation strategy to promote lung cancer screening (LCS) uptake among LCS-eligible women undergoing mammography at BJC West County. This evaluation is grounded in the Integrated Screening Action Model that depicts individual- and environmental-level influences on the screening behavior process. Using an explanatory sequential mixed methods design, which combines both quantitative and qualitative approaches, the research questions and specific aims for this proposal are to: a) evaluate the baseline prevalence of LCS among LCS-eligible women; b) assess whether the Pink \& Pearl Campaign increases referrals and uptake/ completion of LCS among LCS-eligible women undergoing screening mammography; and c) evaluate individual and environmental factors influencing LCS uptake, and implementation outcomes of the campaign. These implementation outcomes will help identify whether the campaign was put in place successfully or not. This proposal will inform strategies for integrating cancer screening programs to improve poorly performing programs like LCS.

Primary outcome measures

  • Prevalence of LCS-eligible women who opt-in to, and successfully, complete LCS mammography and opt-in to lung cancer screening [Time frame: At baseline]
  • Number of women screened for LCS [Time frame: At 3 months]
  • Number of women screened for LCS [Time frame: At 6 months]
  • Feasibility of Pink and Pearl project [Time frame: At 6 months]
  • Acceptability of Pink and Pearl project [Time frame: At 6 months]
  • Appropriateness of Pink and Pearl project [Time frame: At 6 months]
Secondary outcome measures (9)
  • Median time to lung cancer screening [Time frame: Through completion of follow-up (estimated to be 1 year)]
  • Number of women who have a positive lung radiology screening [Time frame: Through completion of follow-up (estimated to be 1 year)]
  • Rate of follow-up for a positive screening examination [Time frame: Through completion of follow-up (estimated to be 1 year)]
  • False positive rates [Time frame: Through completion of follow-up (estimated to be 1 year)]
  • Invasive intervention rate [Time frame: Through completion of follow-up (estimated to be 1 year)]
  • Cancer yield rate [Time frame: Through completion of follow-up (estimated to be 1 year)]
  • Adverse event rate for screening [Time frame: Through completion of follow-up (estimated to be 1 year)]
  • Number of women with varying Stage (1-4) findings in the lung screening radiology report. [Time frame: Through completion of follow-up (estimated to be 1 year)]
  • Cause of death [Time frame: Through completion of follow-up (estimated to be 1 year)]

Eligibility criteria

Inclusion Criteria for Participants:

  • Undergoing screening mammography
  • Between the ages of 50-80 years (inclusive)
  • Reporting a 20 pack-year equivalent of either current smoking history or have quit in the past 15 years
  • Can speak and understand English
  • Ability to understand willingness to provide informed consent.

Exclusion Criteria for Participants:

  • Diagnosed with a serious health problem that will likely limit life expectancy (such as previous history of lung cancer, symptoms of lung cancer such as hemoptysis or unexplained weight loss of more than 6.8 kg (15 lb) in the previous year)
  • Subjects with symptoms of lung cancer should get a diagnostic CT scan
  • Unable or unwilling to get treatment if lung cancer is found

Eligibility Criteria for Providers:

  • Older than 20 years of age

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • Barnes-Jewish Hospital West County — Creve Coeur

Identifiers

NCT: NCT06898333 · 202412064

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗