Targeting Chronic Stress for Reducing Risk Factors for Colorectal Cancer

NCT ID: NCT06323421

Last Updated: 2025-11-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-15
• Study Completion Date: 2025-08-31

Brief 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.

Detailed 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.

Conditions

Mindfulness; Colon Cancer; Females

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Mindfulness

8-week group and individual mindfulness training and practice

Group Type: EXPERIMENTAL

Mindfulness

Intervention Type: BEHAVIORAL

Participants attend seven 60-90 min group mindfulness sessions each week and a 1/2 day retreat, with three sessions in-person and six sessions remote, led by a mindfulness interventionist. Additionally, participants will be encouraged to engage for at least 30 minutes per week in asynchronous mindfulness activities through a web-based program to increase exposure to mindfulness practices beyond group sessions.

Interventions

Mindfulness

Participants attend seven 60-90 min group mindfulness sessions each week and a 1/2 day retreat, with three sessions in-person and six sessions remote, led by a mindfulness interventionist. Additionally, participants will be encouraged to engage for at least 30 minutes per week in asynchronous mindfulness activities through a web-based program to increase exposure to mindfulness practices beyond group sessions.

Intervention Type: BEHAVIORAL

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 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)

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Illinois at Chicago

OTHER

Sponsor Role: lead

Responsible Party

Lisa Tussing-Humphreys

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Illinois Chicago

Chicago, Illinois, United States

Countries

United States

Other Identifiers

STUDY2023-1359

Identifier Type: -

Identifier Source: org_study_id