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Targeting Chronic Stress for Reducing Risk Factors for Colorectal Cancer (MindCRC)

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University of Illinois

Status

Completed

Conditions

Females
Colon Cancer
Mindfulness

Treatments

Behavioral: Mindfulness

Study type

Interventional

Funder types

Other

Identifiers

NCT06323421
STUDY2023-1359

Details and patient eligibility

About

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.

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.

Enrollment

24 patients

Sex

Female

Ages

45 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Female based on sex assigned at birth
  • Self-identify as Black
  • Age 45-65 years old
  • Completed a colonoscopy in the past 24 months,
  • Classify as elevated risk of CRC defined as: any colorectal adenoma detected in past 24 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)

Trial design

Primary purpose

Prevention

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

24 participants in 1 patient group

Mindfulness
Experimental group
Description:
8-week group and individual mindfulness training and practice
Treatment:
Behavioral: Mindfulness

Trial contacts and locations

1

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Central trial contact

Alana Biggers, MD; Lisa Tussing, PhD

Data sourced from clinicaltrials.gov

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