Cancer PRevention Through Enhanced EnvironMenT

NCT06864260 | Active Not Recruiting DMC

• 2 other identifiers: IRB-3000117335U54CA280770-02
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of Cancer PRevention through Enhanced EnvironMenT (Cancer PREEMpT) is to test whether a comprehensive intervention that improves the neighborhood built and social environment can reduce community-level cancer risk in persistent poverty (PP) areas. Our overall hypothesis is that enhancements of the living environment (both built and social) will lower cancer risk through several mechanisms. Built environment improvements will impact walkability (through improved lighting, sidewalks, green space) and access to preventive care (through a mobile wellness van and community health workers), which will stimulate health-related behaviors (physical activity, cancer screening). These improvements will also positively impact safety (through blight removal, traffic calming), social cohesion (through opportunities for socialization), and collective efficacy (through improved neighborhood perceptions). Social environment improvements will increase social cohesion (through community-led events) and collective efficacy (through a Community Leadership Academy and community grants), which will improve public safety as well as facilitate health-related behaviors (physical activity, prevention/wellness). Both types of improvements (built and social environment) will help reduce chronic stress, which will lower the PP community's cancer risk.

Conditions

Cancer Risk

Keywords

cancer; persistent poverty; built environment; social determinants of health; social environment; allostatic load; collective efficacy; perceived stress; cancer screening; neighborhood safety

Outcome Measures

Primary Outcomes (2)

• Proportion of Participants with High Allostatic Load

  10 indicators that make up allostatic load (AL) score, a measure of the cumulative burden of stress. The AL score is defined as sum score of the number of biomarkers that are above the set threshold, with a high level being 3 or more biomarkers above the threshold.

  baseline, up to 3 years

• Average Level of Perceived Stress Among Participants

  10-item Perceived Stress Scale (PSS) which asks about the person's feelings and thoughts during the past month and their frequency (0=Never; 1=Almost Never; 2=Sometimes; 3=Fairly Often; 4=Very Often)

  baseline, up to 3 years

Secondary Outcomes (4)

• Average Self-Reported Leisure Time Physical Activity Among Participants

  baseline, up to 3 years

• Average Healthy Food Access among Participants

  baseline, up to 3 years

• Cancer screening frequency among participants

  baseline, up to 3 years

• Average Social Support among Participants

  baseline, up to 3 years

Study Arms (2)

Pre-Intervention Group

NO INTERVENTION

Baseline data will be collected on participants in this arm before community-level built and social environment modifications (intervention) are implemented.

Post-Intervention Group

EXPERIMENTAL

Post-intervention data will be collected on participants in this arm (different participants than in the pre-intervention group) after community-level built and social environment modifications (intervention) are implemented.

Other: Built Environment; Other: Social Environment

Interventions

Built Environment OTHER

Built environment modifications include sidewalks, sidewalk cuts, traffic-calming devices, crosswalks, transit improvements, green space, street trees, beautification, signage, lighting, wellness van

Post-Intervention Group

Social Environment OTHER

Neighborhood coalition, Community Leadership Academy (LHSA), community-led events, community health workers

Post-Intervention Group

Eligibility Criteria

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

You may qualify if:

• Black race
• English speaker
• Resident of targeted census tract

You may not qualify if:

• Non Black race
• Non-English speaker
• Not a resident of targeted community

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• National Institutes of Health (NIH): collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

Related Publications (13)

• Rodriquez EJ, Kim EN, Sumner AE, Napoles AM, Perez-Stable EJ. Allostatic Load: Importance, Markers, and Score Determination in Minority and Disparity Populations. J Urban Health. 2019 Mar;96(Suppl 1):3-11. doi: 10.1007/s11524-019-00345-5.

  PMID: 30671711 BACKGROUND

• Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.

  PMID: 6668417 BACKGROUND

• Cerin E, Saelens BE, Sallis JF, Frank LD. Neighborhood Environment Walkability Scale: validity and development of a short form. Med Sci Sports Exerc. 2006 Sep;38(9):1682-91. doi: 10.1249/01.mss.0000227639.83607.4d.

  PMID: 16960531 BACKGROUND

• Craig CL, Marshall AL, Sjostrom M, Bauman AE, Booth ML, Ainsworth BE, Pratt M, Ekelund U, Yngve A, Sallis JF, Oja P. International physical activity questionnaire: 12-country reliability and validity. Med Sci Sports Exerc. 2003 Aug;35(8):1381-95. doi: 10.1249/01.MSS.0000078924.61453.FB.

  PMID: 12900694 BACKGROUND

• Pearlin LI, Bierman A. Current Issues and Future Directions in Research into the Stress Process. In: C.S. A, J.C. P, A. B, eds. Handbook of the Sociology of Mental Health. Springer; 2013:325-340.

  BACKGROUND

• Alcaraz KI, Wiedt TL, Daniels EC, Yabroff KR, Guerra CE, Wender RC. Understanding and addressing social determinants to advance cancer health equity in the United States: A blueprint for practice, research, and policy. CA Cancer J Clin. 2020 Jan;70(1):31-46. doi: 10.3322/caac.21586. Epub 2019 Oct 29.

  PMID: 31661164 BACKGROUND

• Gomez SL, Shariff-Marco S, DeRouen M, Keegan TH, Yen IH, Mujahid M, Satariano WA, Glaser SL. The impact of neighborhood social and built environment factors across the cancer continuum: Current research, methodological considerations, and future directions. Cancer. 2015 Jul 15;121(14):2314-30. doi: 10.1002/cncr.29345. Epub 2015 Apr 6.

  PMID: 25847484 BACKGROUND

• Shariff-Marco S, Von Behren J, Reynolds P, Keegan TH, Hertz A, Kwan ML, Roh JM, Thomsen C, Kroenke CH, Ambrosone C, Kushi LH, Gomez SL. Impact of Social and Built Environment Factors on Body Size among Breast Cancer Survivors: The Pathways Study. Cancer Epidemiol Biomarkers Prev. 2017 Apr;26(4):505-515. doi: 10.1158/1055-9965.EPI-16-0932. Epub 2017 Feb 2.

  PMID: 28154107 BACKGROUND

• Lynch SM, Handorf E, Sorice KA, Blackman E, Bealin L, Giri VN, Obeid E, Ragin C, Daly M. The effect of neighborhood social environment on prostate cancer development in black and white men at high risk for prostate cancer. PLoS One. 2020 Aug 13;15(8):e0237332. doi: 10.1371/journal.pone.0237332. eCollection 2020.

  PMID: 32790761 BACKGROUND

• Frank LD, Saelens BE, Powell KE, Chapman JE. Stepping towards causation: do built environments or neighborhood and travel preferences explain physical activity, driving, and obesity? Soc Sci Med. 2007 Nov;65(9):1898-914. doi: 10.1016/j.socscimed.2007.05.053. Epub 2007 Jul 17.

  PMID: 17644231 BACKGROUND

• Obeng-Gyasi S, Tarver W, Carlos RC, Andersen BL. Allostatic load: a framework to understand breast cancer outcomes in Black women. NPJ Breast Cancer. 2021 Jul 30;7(1):100. doi: 10.1038/s41523-021-00309-6. No abstract available.

  PMID: 34330927 BACKGROUND

• Akinyemiju T, Wilson LE, Deveaux A, Aslibekyan S, Cushman M, Gilchrist S, Safford M, Judd S, Howard V. Association of Allostatic Load with All-Cause andCancer Mortality by Race and Body Mass Index in theREGARDS Cohort. Cancers (Basel). 2020 Jun 26;12(6):1695. doi: 10.3390/cancers12061695.

  PMID: 32604717 BACKGROUND

• McEwen BS, Stellar E. Stress and the individual. Mechanisms leading to disease. Arch Intern Med. 1993 Sep 27;153(18):2093-101.

  PMID: 8379800 BACKGROUND

MeSH Terms

Conditions

Neoplasms

Interventions

Built Environment

Intervention Hierarchy (Ancestors)

Environment Design; Environment; Environment and Public Health

Study Officials

• Lori B Bateman, PhD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

• Gabriela R Oates, PhD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Using a sequential explanatory mixed methods design, quantitative (surveys) and qualitative (focus groups) data will be collected to assess community-level changes in perceptions and behaviors in targeted census tracts. To measure chronic stress objectively (as a proxy for cancer risk), study staff will draw blood to measure stress biomarkers, which will include 10 indicators of allostatic load. A two-group design with independent, mutually exclusive samples pre- and post-intervention will be utilized.

Study Record Dates

• First Submitted: March 3, 2025
• First Posted: March 7, 2025
• Study Start: May 1, 2024
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): April 30, 2028
• Last Updated: March 11, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: From 3 months to 5 years after publication date
• Access Criteria: Deidentified individual data that supports publication results will be shared beginning 3 months and up to 60 months following publication, provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UAB.

Locations

US (1)