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

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.

Study Overview

• Status: Recruiting
• Conditions: Lung Cancer; Cancer of the Lung

• Study Type: Observational
• Enrollment (Estimated): 279

Contacts and Locations

• Study Contact: Name: Beryne Odeny, M.D., MPH, Ph.D.; Phone Number: 314-362-1183; Email: beryne@wustl.edu

Study Locations

• United States
  • Missouri
    • Creve Coeur, Missouri, United States, 63141
      • Recruiting
      • Barnes-Jewish Hospital West County
      • Contact: Beryne Odeny, M.D, MPH, Ph.D.; Phone Number: 314-362-1183; Email: beryne@wustl.edu
      • Principal Investigator: Beryne Odeny, M.D., MPH, Ph.D.
      • Sub-Investigator: Michelle V Lee, M.D.
      • Sub-Investigator: Aren B Mntzakanian, M.S.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Women within the BJC West County electronic health record (EHR) who are scheduled to undergo screening mammography and are eligible for LCS, based on 2021 USPSTF guidelines. In addition to patients, healthcare providers involved in the breast radiology service who referred women to the Pink and Pearl project will also be included as study participants for the qualitative in-depth interviews. This group may include medical doctors, nurse practitioners, nurses, nurse navigators, and physician assistants. Up to 15 healthcare providers will be interviewed.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Participants - scheduled for mammography and eligible for LCS; Women who are scheduled for mammography and are potentially LCS-eligible will be approached by the registration team and will complete a survey. Subjects who were referred for LCS will be contacted and the investigators will gauge their interest in returning for dual breast and lung screening program in future and rate their experience on a patient satisfaction scale.
Providers; Providers in the breast radiology service who referred women to LCS. Investigators will gather information on the feasibility, acceptability, and appropriateness of the Pink and Pearl project.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of LCS-eligible women who opt-in to, and successfully, complete LCS mammography and opt-in to lung cancer screening		At baseline
Number of women screened for LCS		At 3 months
Number of women screened for LCS		At 6 months
Feasibility of Pink and Pearl project	Feasibility 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.	At 6 months
Acceptability of Pink and Pearl project	Acceptability 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.	At 6 months
Appropriateness of Pink and Pearl project	Appropriateness 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.	At 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Median time to lung cancer screening		Through completion of follow-up (estimated to be 1 year)
Number of women who have a positive lung radiology screening		Through completion of follow-up (estimated to be 1 year)
Rate of follow-up for a positive screening examination		Through completion of follow-up (estimated to be 1 year)
False positive rates		Through completion of follow-up (estimated to be 1 year)
Invasive intervention rate	Invasive interventions are considered percutaneous cytologic examination or biopsy, bronchoscopy, surgical procedure mediastinoscopy/otmy, and thorascopy/otmy.	Through completion of follow-up (estimated to be 1 year)
Cancer yield rate		Through completion of follow-up (estimated to be 1 year)
Adverse event rate for screening		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.	Histologic type (Bronchioloalveolar carcinoma, adenocarcinoma, squamous-cell carcinoma, large-cell carcinoma, non-small-cell carcinoma or other, small-cell carcinoma, carcinoid).	Through completion of follow-up (estimated to be 1 year)
Cause of death	Neoplasm of bronchus and lung, other neoplasm, cardiovascular illness, respiratory illness, complications of medical or surgical care, other.	Through completion of follow-up (estimated to be 1 year)

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Investigators: Principal Investigator: Beryne Odeny, M.D., MPH, Ph.D., Washington University School of Medicine

Publications and helpful links

Helpful Links

• Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): May 8, 2025
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): May 31, 2027

Study Registration Dates

• First Submitted: March 20, 2025
• First Submitted That Met QC Criteria: March 20, 2025
• First Posted (Actual): March 27, 2025

Study Record Updates

• Last Update Posted (Actual): May 19, 2026
• Last Update Submitted That Met QC Criteria: May 16, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Feasibility; Acceptability; Health disparities; Appropriateness; Low-dose computed tomography (LDCT); Smoking history; Lung cancer screening (LCS); Pink and Pearl Campaign; Breast cancer screening (BCS); Screening behavior
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: 202412064

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Plan to share results interpretations.
• IPD Sharing Time Frame: For a period of 1 year.
• IPD Sharing Access Criteria: Contact the Principal Investigator or Central Contact Back-up via email.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No