Clinical trial NCT06898333: Implementation and Effectiveness of the BJC-Pink and Pearl Project on Lung Cancer Screening
Official title: Evaluating the Implementation and Effectiveness of the BJC-Pink and Pearl Project on Lung Cancer Screening
Study type: OBSERVATIONAL
Overall status: RECRUITING
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
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2025-03-27
Enrollment: 279
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


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

Primary outcomes:
measure: Prevalence of LCS-eligible women who opt-in to, and successfully, complete LCS mammography and opt-in to lung cancer screening
timeFrame: At baseline
measure: Number of women screened for LCS
timeFrame: At 3 months
measure: Number of women screened for LCS
timeFrame: At 6 months
measure: Feasibility of Pink and Pearl project
timeFrame: At 6 months
measure: Acceptability of Pink and Pearl project
timeFrame: At 6 months
measure: Appropriateness of Pink and Pearl project
timeFrame: At 6 months
Secondary outcomes:
measure: Median time to lung cancer screening
timeFrame: Through completion of follow-up (estimated to be 1 year)
measure: Number of women who have a positive lung radiology screening
timeFrame: Through completion of follow-up (estimated to be 1 year)
measure: Rate of follow-up for a positive screening examination
timeFrame: Through completion of follow-up (estimated to be 1 year)
measure: False positive rates
timeFrame: Through completion of follow-up (estimated to be 1 year)
measure: Invasive intervention rate
timeFrame: Through completion of follow-up (estimated to be 1 year)
measure: Cancer yield rate
timeFrame: Through completion of follow-up (estimated to be 1 year)
measure: Adverse event rate for screening
timeFrame: Through completion of follow-up (estimated to be 1 year)
measure: Number of women with varying Stage (1-4) findings in the lung screening radiology report.
timeFrame: Through completion of follow-up (estimated to be 1 year)
measure: Cause of death
timeFrame: Through completion of follow-up (estimated to be 1 year)
Other outcomes:
Locations:
city: Creve Coeur
country: United States
facility: Barnes-Jewish Hospital West County
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Beryne Odeny, M.D., MPH, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: