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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06898333
Enrollment
279
Registered
2025-03-27
Start date
2025-05-08
Completion date
2027-05-31
Last updated
2026-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer of the Lung, Lung Cancer

Keywords

Lung cancer screening (LCS), Pink and Pearl Campaign, Breast cancer screening (BCS), Low-dose computed tomography (LDCT), Smoking history, Health disparities, Screening behavior, Feasibility, Acceptability, Appropriateness

Brief summary

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.

Interventions

None listed

Sponsors

Washington University School of Medicine
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Prevalence of LCS-eligible women who opt-in to, and successfully, complete LCS mammography and opt-in to lung cancer screeningAt baseline
Number of women screened for LCSAt 3 months
Feasibility of Pink and Pearl projectAt 6 monthsFeasibility is defined as the extent to which the strategy is suitable for routine use in a setting. Information on the feasibility of the Pink and Pearl campaign from healthcare providers will be collected using in-depth interviewing.
Acceptability of Pink and Pearl projectAt 6 monthsAcceptability is defined as the perception that the strategy is agreeable or satisfactory. Information on the acceptability of the Pink and Pearl campaign from healthcare providers will be collected using in-depth interviewing.
Appropriateness of Pink and Pearl projectAt 6 monthsAppropriateness is defined as the perceived fit, relevance, or compatibility of the strategy or practice for a given setting. Information on the appropriateness of the Pink and Pearl campaign from healthcare providers will be collected using in-depth interviewing.

Secondary

MeasureTime frameDescription
Median time to lung cancer screeningThrough completion of follow-up (estimated to be 1 year)
Number of women who have a positive lung radiology screeningThrough completion of follow-up (estimated to be 1 year)
Rate of follow-up for a positive screening examinationThrough completion of follow-up (estimated to be 1 year)
False positive ratesThrough completion of follow-up (estimated to be 1 year)
Invasive intervention rateThrough completion of follow-up (estimated to be 1 year)Invasive interventions are considered percutaneous cytologic examination or biopsy, bronchoscopy, surgical procedure mediastinoscopy/otmy, and thorascopy/otmy.
Cancer yield rateThrough completion of follow-up (estimated to be 1 year)
Adverse event rate for screeningThrough completion of follow-up (estimated to be 1 year)
Number of women with varying Stage (1-4) findings in the lung screening radiology report.Through completion of follow-up (estimated to be 1 year)Histologic type (Bronchioloalveolar carcinoma, adenocarcinoma, squamous-cell carcinoma, large-cell carcinoma, non-small-cell carcinoma or other, small-cell carcinoma, carcinoid).
Cause of deathThrough completion of follow-up (estimated to be 1 year)Neoplasm of bronchus and lung, other neoplasm, cardiovascular illness, respiratory illness, complications of medical or surgical care, other.

Countries

United States

Contacts

CONTACTBeryne Odeny, M.D., MPH, Ph.D.
beryne@wustl.edu314-362-1183
PRINCIPAL_INVESTIGATORBeryne Odeny, M.D., MPH, Ph.D.

Washington University School of Medicine

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 13, 2026