Colon Cancer Clinical Trial

Targeting Chronic Stress for Reducing Risk Factors for Colorectal Cancer

Summary

Many neighborhoods in Chicago experience daily exposure to stressors including economic inopportunity and violent crime in public spaces. There is mounting evidence that chronic psychosocial stress can facilitate carcinogenesis by modulating the gut microbiome and immune system. The proposed research aims to study the practice of mindfulness to mitigate CPS and reduce colorectal cancer risk factors among Black American women at elevated risk.

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Full Description

Chronic stress can directly and indirectly promote carcinogenesis through immune, metabolic, and microbial pathways. Our overarching hypothesis is that reducing chronic stress will have important implications for colon cancer risk reduction among vulnerable and high-risk populations. A promising approach for reducing chronic stress is mindfulness practices. Mindfulness is a meditation-based technique to achieve a state of mind used to experience higher awareness or consciousness. We propose to pilot test an 8-week Mindfulness intervention delivered in a hybrid format (synchronous and asynchronous sessions) among 40 Black females at elevated risk of colon cancer, who reside in vulnerable communities and who report moderate to high perceived stress. At baseline and post-intervention, participants will provide blood and stool undergo body composition analysis, and complete mood and lifestyle-related surveys. The specific aims are to: test the feasibility and acceptability of the intervention and evaluate the preliminary effect on stress and weight, fasting glucose, inflammation markers, and the gut microbiome - risk markers and risk pathways associated with colon tumorigenesis. While relieving social stressors is the paramount goal, addressing chronic stress at the individual level is achievable now, with implications for CRC risk reduction. If successful, data generated here will serve in developing a fully powered trial to test if MBSR is efficacious for CRC risk reduction among high-risk vulnerable populations in Chicago.

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Eligibility Criteria

Inclusion Criteria:

Female based on sex assigned at birth
Self-identify as Black
Age 45-65 years old
Completed a colonoscopy in the past 12 months,
Classify as elevated risk of CRC defined as ≥ 3 colorectal adenomas or one colorectal adenoma > 1 cm in the past 12 months)Own and use a smartphone, computer, or tablet with access to the Internet
Score ≥ 14 on the PSS at screening
Reside in a Chicago community with high violent crime

Exclusion Criteria:

History of CRC
Antibiotics (oral/IV) in the past 2 months
Inflammatory bowel disease or genetic predisposition to CRC
Cancer diagnosis or cancer treatment in the past 12 months
Consume > 50 grams of ethanol daily
Use combustible tobacco
Bariatric surgery or bowel resection
Immunodeficiency/autoimmune disease
Uncontrolled diabetes (HbA1c > 9% based on EHR)
Fiber or pre-/probiotic supplements > 3 days per week
Serrated adenoma at the recent colonoscopy given the molecular features are distinct
Significant health conditions or take medications that impact participation or expected outcomes (e.g., β-blocker, Cushing's syndrome, and corticosteroids - inhaled, topical, oral in the past month given effects on hair cortisol measurement)

Study is for people with:

Colon Cancer

Estimated Enrollment:

40

Study ID:

NCT06323421

Recruitment Status:

Not yet recruiting

Sponsor:

University of Illinois at Chicago

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University of Illinois at Chicago
Chicago Illinois, 60612, United States More Info
Lisa Tussing-Humphreys, PhD
Contact
312-355-5521
[email protected]

How clear is this clinincal trial information?

Study is for people with:

Colon Cancer

Estimated Enrollment:

40

Study ID:

NCT06323421

Recruitment Status:

Not yet recruiting

Sponsor:


University of Illinois at Chicago

How clear is this clinincal trial information?

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