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Recruiting NCT07231159

Building on Trust: Navigating Preventive Lung, Breast, and Prostate Cancer Screenings at Community Resource Spots

— Observational Breast Cancer Lung Cancer (Diagnosis) Prostate Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: referral for definitive diagnosis based on their cancer screening results, Engagement.
Who it may be relevant to
Registry conditions: Breast Cancer, Lung Cancer (Diagnosis), Prostate Cancer. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

To evaluate a community-based outreach initiative for screening, diagnosis, and treatment of breast, lung, and prostate cancers in underserved adults using the Reach, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM) implementation science framework.

Interventions

  • Behavioral referral for definitive diagnosis based on their cancer screening results
    Need for radiological diagnosis
  • Behavioral Engagement
    Engage in stakeholder focus groups to provide feedback about program operations

Primary outcome measures

  • The categorization of the RE-AIM model dimensions of Reach, Effectiveness, Adoption, Implementation, and Maintenance, [Time frame: From enrollment to the end of the 3 month follow-up for a total of 12 months]
Secondary outcome measures (2)
  • PROMIS Global Health (HR-QoL) scale [Time frame: From enrollment to the end of the 3 month follow-up for a total of 12 months]
  • Patient Satisfaction with Logistical Aspects of Navigation Scale (PSN-L) [Time frame: From enrollment to the end of the 3 month follow-up for a total of 12 months]

Eligibility criteria

Inclusion criteria

  • Adult aged 18 or older
  • Seeking care at a CRS or emergency department
  • Meets criteria for lung, breast, and/or prostate cancer screening, as outlined below:
  • Lung cancer: Adults aged 50 to 80 years who have a 20 pack-year smoking history and currently smoke or have quit within the past 15 years
  • Breast cancer: Women aged 40 to 74 years
  • Prostate cancer: Men aged 55 to 69 years
  • Receives a positive screening result for lung, breast, and/or prostate cancer at a study site

Exclusion criteria

  • Displays behavior disruptive to other patients or staff
  • Refusal to accept screening for breast, lung, and/or prostate cancers

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • Adventhealth — Orlando

Publications

  • Kumar AJ, Banco D, Steinberger EE, Chen J, Weidner R, Makim S, Parsons SK. Time to diagnostic resolution after an uncertain screening mammogram in an underserved population. Cancer Med. 2020 May;9(9):3252-3258. doi: 10.1002/cam4.2970. Epub 2020 Mar 11. PMID 32160406
  • Holtrop JS, Rabin BA, Glasgow RE. Qualitative approaches to use of the RE-AIM framework: rationale and methods. BMC Health Serv Res. 2018 Mar 13;18(1):177. doi: 10.1186/s12913-018-2938-8. PMID 29534729
  • Hays RD, Bjorner JB, Revicki DA, Spritzer KL, Cella D. Development of physical and mental health summary scores from the patient-reported outcomes measurement information system (PROMIS) global items. Qual Life Res. 2009 Sep;18(7):873-80. doi: 10.1007/s11136-009-9496-9. Epub 2009 Jun 19. PMID 19543809
  • Carle AC, Jean-Pierre P, Winters P, Valverde P, Wells K, Simon M, Raich P, Patierno S, Katz M, Freund KM, Dudley D, Fiscella K. Psychometric evaluation of the patient satisfaction with logistical aspects of navigation (PSN-L) scale using item response theory. Med Care. 2014 Apr;52(4):354-61. doi: 10.1097/MLR.0000000000000089. PMID 24848207
  • Chen M, Wu VS, Falk D, Cheatham C, Cullen J, Hoehn R. Patient Navigation in Cancer Treatment: A Systematic Review. Curr Oncol Rep. 2024 May;26(5):504-537. doi: 10.1007/s11912-024-01514-9. Epub 2024 Apr 6. PMID 38581470
  • Braun, V., Clarke, V. (2006). Using thematic analysis in psychology. Qualitative Research in Psychology, 3, 77-101
  • Bell-Brown A, Watabayashi K, Delaney D, Carlos RC, Langer SL, Unger JM, Vaidya RR, Darke AK, Hershman DL, Ramsey SD, Shankaran V. Assessment of financial screening and navigation capabilities at National Cancer Institute community oncology clinics. JNCI Cancer Spectr. 2023 Aug 31;7(5):pkad055. doi: 10.1093/jncics/pkad055. PMID 37561111

Identifiers

NCT: NCT07231159 · 2343026 · 333

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗