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Clinical Trials/NCT06864260
NCT06864260Active, not recruitingNot Applicable

Cancer PRevention Through Enhanced EnvironMenT

University of Alabama at Birmingham1 site in 1 country300 target enrollmentStarted: May 1, 2024Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Enrollment
300
Locations
1
Primary Endpoint
Proportion of Participants with High Allostatic Load

Study Overview

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.

Detailed Description

Disparities in cancer prevention and outcomes by poverty status are well documented. Such disparities are rooted in structural and intermediate social determinants of health (SDOH), including neighborhood built and social environment (together referred to as living environment). Features of the living environment have major implications for cancer risk through behaviors such as physical activity and access to preventive care. Adverse neighborhood conditions also exacerbate the stress response, in the form of high allostatic load, which is a risk factor for many cancers. Reducing cancer disparities in persistent poverty (PP) areas requires a multisectoral approach in which citizens, organizations, businesses, and local governments unite to improve neighborhood conditions. However, despite compelling evidence that the living environment impacts health-related behaviors and outcomes, including cancer, there are virtually no interventions that determine to what extent modifications of the neighborhood built and social environments reduce cancer risk. Based on the Alcarez framework, the proposed study aims to fill this knowledge gap. The purpose of the study is to understand if interventions aimed at improving neighborhood built and social environment can reduce community-level cancer risk in 5 targeted PP neighborhoods (census tracts). Study specific aims are as follows:

Aim 1. Implement Cancer PREEMpT and assess whether the enhancement of living environment leads to increased public safety, use of parks and community spaces, community events, and prevention services.

After a community-engaged needs assessment, built and social environment improvements will be implemented in collaboration with our study partner, Live HealthSmart Alabama (LHSA). Public usage data will be gathered regarding public safety, use of parks and community spaces, and community events. The LHSA wellness van will visit PREEMpT targeted communities on a monthly basis for preventive assessments and referrals to primary care and cancer screening (cervical, breast, and colon). The public usage data will be gathered through non-human subjects (numeric counts, public crime data, and civil data). The prevention data will be gathered by the LHSA wellness van staff through de-identified counts of uptake of services by community members.

Aim 2. Determine the effect of improved living environment on community-level perceptions and behaviors related to cancer risk.

Using a sequential explanatory mixed methods design, surveys will be collected and focus groups will be conducted to assess community-level changes in perceptions and behaviors in the targeted areas. For the quantitative (survey) component, a two-group survey design will be used with independent, mutually exclusive samples pre- and post-intervention, and for the qualitative (focus group) component, focus groups with residents pre- and post-intervention will be conducted.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Sequential
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

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

Exclusion Criteria

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

Arms & Interventions

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.

Intervention: Built Environment (Other)

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.

Intervention: Social Environment (Other)

Outcomes

Primary Outcomes

Proportion of Participants with High Allostatic Load

Time Frame: baseline, up to 3 years

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.

Average Level of Perceived Stress Among Participants

Time Frame: baseline, up to 3 years

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)

Secondary Outcomes

  • Average Healthy Food Access among Participants(baseline, up to 3 years)
  • Average Self-Reported Leisure Time Physical Activity 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)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Lori Bateman

Assistant Professor

University of Alabama at Birmingham

Study Sites (1)

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