Clinical trial NCT06864260: Cancer PRevention Through Enhanced EnvironMenT
Official title: Cancer PRevention Through Enhanced EnvironMenT
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
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
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Cancer Institute (NCI)
First posted: 2025-03-07
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: 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.
Primary purpose: PREVENTION

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.

(2.1) SURVEYS. Surveys will be conducted with 150 participants from the targeted areas at baseline and 150 surveys with another set of participants from the targeted area in the last year of the study. The surveys will be administered by the staff of UAB Recruitment and Retention Shared Facility (RRSF).

(2.2) FOCUS GROUPS: 3 focus groups will be conducted at baseline and in the last year of the project, with approximately 6-10 participants per group. Participants will be randomly selected from those who complete pre- and post-intervention surveys (in 2.1 above). Focus groups will be moderated by trained staff who will a use semi-structured focus group guide to explore external barriers, facilitators, and community cultural norms associated with physical activity, safety, and wellness, with an emphasis on cancer prevention. Participants will also discuss factors related to the neighborhood built environment, social environment, and perceptions of crime.

Aim 3. Evaluate the impact of improved living environments on perceived and objective chronic stress.

Perceived Stress - Self-reported stress will be measured with the Perceived Stress Scale included in the Aim 2 surveys.

Objective Chronic Stress - Blood will be drawn in a sub-sample of participants to measure stress biomarkers, which will include 10 measures of allostatic load (AL). To assess community-level changes in AL, an experimental two-group design will be used with independent, mutually exclusive samples at baseline and Year 5. At baseline, 50 participants from the 150 survey respondents enrolled in the pre-intervention group (Aim 2) will be randomly selected, and at Year 5, 50 participants from the 150 survey respondents enrolled in the post-intervention group (Aim 2) will be randomly selected (for a total N = 100).

Eligibility criteria: 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

Primary outcomes:
measure: Proportion of Participants with High Allostatic Load
timeFrame: baseline, up to 3 years
measure: Average Level of Perceived Stress Among Participants
timeFrame: baseline, up to 3 years
Secondary outcomes:
measure: Average Self-Reported Leisure Time Physical Activity Among Participants
timeFrame: baseline, up to 3 years
measure: Average Healthy Food Access among Participants
timeFrame: baseline, up to 3 years
measure: Cancer screening frequency among participants
timeFrame: baseline, up to 3 years
measure: Average Social Support among Participants
timeFrame: baseline, up to 3 years
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Lori B Bateman, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Alabama at Birmingham
name: Gabriela R Oates, PhD
role: PRINCIPAL_INVESTIGATOR
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