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

NCT06898333 | Recruiting

• 1 other identifier: 202412064
• Study Type: observational
• Target: 279
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Cancer; Cancer of the Lung

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

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (9)

• 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

  Through completion of follow-up (estimated to be 1 year)

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Barnes-Jewish Hospital West County

Creve Coeur, Missouri, 63141, United States

RECRUITING

Related Links

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

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Beryne Odeny, M.D., MPH, Ph.D.

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Beryne Odeny, M.D., MPH, Ph.D.

CONTACT

314-362-1183; beryne@wustl.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2025
• First Posted: March 27, 2025
• Study Start: May 8, 2025
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): May 31, 2027
• Last Updated: March 25, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: For a period of 1 year.
• Access Criteria: Contact the Principal Investigator or Central Contact Back-up via email.

Locations

US (1)