Lung CancerNCT06898333
Implementation and Effectiveness of the BJC-Pink and Pearl Project on Lung Cancer Screening
An observational study of Lung Cancer and Cancer of the Lung, run by Washington University School of Medicine at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lung Cancer, Cancer of the Lung
- How many people
- 279 participants
- Where
- 1 siteUnited States
- Study dates
- 8 May 2025to 31 May 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Barnes-Jewish Hospital West County
Creve Coeur, Missouri, 63141
Beryne Odeny, M.D, MPH, Ph.D., 314-362-1183, beryne@wustl.edu
Beryne Odeny, M.D., MPH, Ph.D.
About this study
Official title: 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.
- 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
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of LCS-eligible women who opt-in to, and successfully, complete LCS mammography and opt-in to lung cancer screening
Measured: At baseline
Number of women screened for LCS
Measured: At 3 months
Number of women screened for LCS
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At 6 months
Secondary outcomes (9)
Median time to lung cancer screening
Measured: Through completion of follow-up (estimated to be 1 year)
Number of women who have a positive lung radiology screening
Measured: Through completion of follow-up (estimated to be 1 year)
Rate of follow-up for a positive screening examination
Measured: Through completion of follow-up (estimated to be 1 year)
False positive rates
Measured: 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.
Measured: Through completion of follow-up (estimated to be 1 year)
Cancer yield rate
Measured: Through completion of follow-up (estimated to be 1 year)
Adverse event rate for screening
Measured: 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).
Measured: 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.
Measured: Through completion of follow-up (estimated to be 1 year)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2025
- Study start8 May 2025
- Primary completion30 Nov 2026 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 279 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Beryne Odeny, M.D., MPH, Ph.D., Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06898333
- Sponsor's protocol ID
- 202412064
- Status last verified
- Aug 2026
- First submitted
- 20 Mar 2025
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Plan to share results interpretations.
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Implementation and Effectiveness of the BJC-Pink and Pearl Project on Lung Cancer Screening
- ClinicalTrials.gov ID
- NCT06898333
- Acronym / sponsor ID
- 202412064
- 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
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 279 participants (estimated)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- 8 May 2025 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 27 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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)
- Unable or unwilling to get treatment if lung cancer is found
- Older than 20 years of age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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.
Acceptability of Pink and Pearl project
Time frame: At 6 months
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.
Appropriateness of Pink and Pearl project
Time frame: At 6 months
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.
9 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Plan to share results interpretations.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Beryne Odeny, M.D., MPH, Ph.D. principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer and Cancer of the Lung, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Beryne Odeny, M.D., MPH, Ph.D. (314-362-1183, beryne@wustl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2026.