NCT07146568

Brief Summary

Inspired by the ongoing Pink \& Pearl Campaign, the breast radiology service of Christian Hospital in north St. Louis County will partner with Siteman Cancer Center to pilot this campaign in its mammography clinics in order to promote awareness, referral, and completion of lung cancer screening (LCS) among eligible women. This campaign leverages established infrastructure such as nurse navigation and referral to screening or primary care for further shared decision-making on cancer screening. The purpose of this study is to evaluate the effectiveness of the Pink \& Pearl Campaign in improving LCS uptake among LCS-eligible women undergoing mammography at Christian Hospital. 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, our specific aims for this proposal are to: a) assess whether the Pink \& Pearl Campaign increases referrals and uptake/completion of LCS among LCS-eligible women undergoing screening mammography; b) determine median time-to-screening after referral to LCS; and c) evaluate individual and health system 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,515

participants targeted

Target at P75+ for not_applicable lung-cancer

Timeline
4mo left

Started Feb 2026

Shorter than P25 for not_applicable lung-cancer

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress39%
Feb 2026Aug 2026

First Submitted

Initial submission to the registry

August 21, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 28, 2025

Completed
6 months until next milestone

Study Start

First participant enrolled

February 23, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2026

Last Updated

February 24, 2026

Status Verified

February 1, 2026

Enrollment Period

6 months

First QC Date

August 21, 2025

Last Update Submit

February 23, 2026

Conditions

Keywords

Lung cancer screening (LCS)Pink and Pearl CampaignBreast cancer screening (BCS)Low-dose computed tomography (LDCT)Smoking historyHealth disparitiesScreening behaviorFeasibilityAcceptabilityAppropriateness

Outcome Measures

Primary Outcomes (1)

  • Proportion of women referred from the breast radiology service who successfully complete LCS 6-months post-Pink & Pearl implementation

    The investigators will compare the baseline prevalence of LCS among women undergoing BCS to the prevalence of LCS among women undergoing BCS 6 months after implementation of the Pink \& Pearl Campaign.

    At 6 months

Secondary Outcomes (2)

  • Median time-to-screening

    At 6 months

  • Acceptability of Pink & Pearl Campaign

    At 6 months

Other Outcomes (4)

  • Number of individual level barriers to LCS completion

    At 6 months

  • Number of health system level barriers to LCS completion

    At 6 months

  • Feasibility of Pink & Pearl Campaign

    At 6 months

  • +1 more other outcomes

Study Arms (2)

Participants - scheduled for mammography and eligible for LCS

EXPERIMENTAL

All women coming in for breast cancer screening will be assessed for LCS eligibility using a screening questionnaire administered by mammography technicians. Patients who are determined to be eligible for LCS will be asked by the mammography technician if they will opt into being contacted by the nurse navigator, who will facilitate their referral to primary care to schedule a LCS appointment at Siteman Cancer Center.

Other: Pink and Pearl Campaign

Providers

NO INTERVENTION

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.

Interventions

This campaign leverages established infrastructure such as nurse navigation and referral to screening or primary care for further shared decision-making on cancer screening.

Participants - scheduled for mammography and eligible for LCS

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Eligibility Criteria - Interventional Study * Undergoing screening mammography at Christian Hospital * Between the ages of 50-80 years (inclusive) Eligibility Criteria - Survey and Interview Sub-Studies * Part of the interventional study * Reporting a 20 pack-year equivalent of either current smoking history or have quit in the past 15 years * Can speak and understand English * Not diagnosed with a serious health problem that will 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) * Willing and able to get treatment if lung cancer is found * Able to understand and willing to sign an IRB-approved written informed consent document Eligibility Criteria - Providers * At least 20 years of age * Involved in the breast radiology service or referred at least one patient to the Pink \& Pearl Campaign * Able to provide verbal consent to participate in the interview

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Barnes-Jewish Christian Hospital

St Louis, Missouri, 63136, United States

RECRUITING

Related Links

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory 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

Michelle V Lee, M.D.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 21, 2025

First Posted

August 28, 2025

Study Start

February 23, 2026

Primary Completion (Estimated)

August 31, 2026

Study Completion (Estimated)

August 31, 2026

Last Updated

February 24, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will share

Plan to share results interpretations.

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