Environmental and Social Interventions for Cancer Risk

(PREEMpT Trial)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Alabama at Birmingham

Disqualifiers: Non Black, Non-English, Non-resident

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

300 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on environmental and social interventions rather than medication changes.

What data supports the effectiveness of the treatment Cancer Prevention Through Enhanced EnvironMent?

Research shows that avoiding harmful behaviors like smoking, improving diet, increasing physical activity, and managing weight can help prevent cancer. These strategies are effective when they involve community support and are tailored to people's unique needs, suggesting that environmental and social interventions can be beneficial in cancer prevention. ^{1 2 3 4 5}

Is the treatment generally safe for humans?

The research highlights the importance of reducing harmful chemical exposures and environmental carcinogens to prevent cancer, but it does not provide specific safety data for the treatment itself. It emphasizes the need for careful monitoring and regulation of environmental factors to ensure safety. ^{6 7 8 9 10}

How does the treatment 'Cancer Prevention Through Enhanced EnvironMent' differ from other cancer prevention treatments?

This treatment is unique because it focuses on modifying environmental and social factors to prevent cancer, rather than relying on traditional medical interventions like drugs or surgery. It emphasizes changing the world around us to create a less cancer-causing environment, which is a novel approach compared to standard cancer prevention methods. ^{2 10 11 12 13}

What is the purpose of this trial?

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.

Research Team

Lori B Bateman, PhD

Principal Investigator

University of Alabama at Birmingham

Gabriela R Oates, PhD

Principal Investigator

University of Alabama at Birmingham

Eligibility Criteria

This trial is for people living in areas with persistent poverty, where there's a higher risk of cancer due to the environment. It's open to those who could benefit from improved neighborhood conditions like better lighting, sidewalks, and social programs.

Inclusion Criteria

Resident of targeted census tract

Black race

Exclusion Criteria

Non-Black race

Non-English speaker

Not a resident of targeted community

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-Intervention

Baseline data collection on participants before community-level built and social environment modifications

up to 3 years

Intervention

Implementation of built and social environment improvements in collaboration with Live HealthSmart Alabama

up to 3 years

Post-Intervention

Data collection on participants after community-level built and social environment modifications

up to 3 years

Follow-up

Participants are monitored for changes in cancer risk factors and stress levels

up to 3 years

Treatment Details

Interventions

• Cancer Prevention Through Enhanced EnvironMent

Trial Overview Cancer PREEMpT is testing if enhancing both the physical (built) and social environments can lower cancer risk. This includes making neighborhoods more walkable, increasing access to preventive care, organizing community events, and fostering local leadership.

Participant Groups

Group I: Post-Intervention Group Experimental Treatment 2 Interventions

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.

Group II: Pre-Intervention Group Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Findings from Research

Behavioral risk factors like tobacco use, diet, physical activity, and obesity are linked to cancer, but effective interventions can significantly reduce cancer incidence, as seen in the recent decline in lung cancer rates.

Successful cancer prevention strategies incorporate multiple components, such as individual and family activities, community involvement, and are guided by behavioral theories that emphasize self-efficacy and social support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavior and cancer prevention. Gotay, CC.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

Co-ordination and ecology in practical cancer prevention. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Human behavior and cancer. Forget the magic bullet! [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Behavior and cancer prevention. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Model for incorporating social context in health behavior interventions: applications for cancer prevention for working-class, multiethnic populations. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Cancer Risk Studies and Priority Areas for Cancer Risk Appraisal in Uganda. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Primary prevention of cancer: needs and opportunities for research. [2018]

7. United States pubmed.ncbi.nlm.nih.gov

Rethinking Environmental Carcinogenesis. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Cancer Hazard Evaluations for Contemporary Needs: Highlights From New National Toxicology Program Evaluations and Methodological Advancements. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Cancer prevention in the workplace and natural environment. A review of etiology, research design, and methods of risk reduction. [2019]

10. United States pubmed.ncbi.nlm.nih.gov

California Breast Cancer Prevention Initiatives: Setting a research agenda for prevention. [2015]

11. United States pubmed.ncbi.nlm.nih.gov

Perspectives on cancer prevention. [2019]

12. United States pubmed.ncbi.nlm.nih.gov

Environmental Determinants of Breast Cancer. [2019]

13. United States pubmed.ncbi.nlm.nih.gov

Skin cancer interventions across the cancer control continuum: Review of technology, environment, and theory. [2023]