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

Mindfulness and CRC Risk Factor Reduction: Targeting Chronic Stress For Colorectal Cancer Risk Factor Reduction A Pilot Feasibility Study Among Vulnerable At-Risk Black Females

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.

Study Overview

• Status: Completed
• Conditions: Colon Cancer; Mindfulness; Females
• Intervention / Treatment: Behavioral: Mindfulness

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.

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60612
      • University of Illinois Chicago

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Mindfulness; 8-week group and individual mindfulness training and practice

Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility measures	easible if ≥ 30% of those approached enroll at a minimum rate of 1-3 women/week for each wave and ≥ 80% of women enrolled are retained with complete data collection at both assessment time-point	Monitored across the duration of study and 8-week intervention
Acceptability	The intervention will be deemed acceptable if women attend ≥ 80% of the Mindfulness group sessions, engage with ≥ 80% of the asynchronous Mindfulness content and score ≥ 16 on the acceptability survey.	Week 4 and post-intervention at week 9

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body mass index	weight in kg divided by height in meters squared	Baseline and post-intervention at week 9
Stress measure	Hair cortisol concentration	Baseline and post-intervention at week 9
Fasting glucose	Measured in serum	Baseline and post-intervention at week 9
Gut microbiota composition	16S rRNA amplicon sequencing from stool	Baseline and post-intervention at week 9
Gut inflammation	Fecal calprotectin	Baseline and post-intervention at week 9
Adiposity	% body fat and visceral body fat area from whole body DEXA	Baseline and post-intervention at week 9
Epinephrine	From serum measured via mass spectrometry	Baseline and post-intervention at week 9
Norepinephrine	From serum measured via mass spectrometry	Baseline and post-intervention at week 9
Cortisol	From serum measured via mass spectrometry	Baseline and post-intervention at week 9
Resting heart rate	Measured with an electronic monitor	Baseline and post-intervention at week 9
Blood lipids	From serum - total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides	Baseline and post-intervention at week 9
Fasting insulin	From serum	Baseline and post-intervention at week 9
Hemoglobin A1c	From whole blood	Baseline and post-intervention at week 9
Systemic inflammation	C-reactive protein measured in serum	Baseline and post-intervention at week 9

Collaborators and Investigators

• Sponsor: University of Illinois at Chicago
• Collaborators: National Cancer Institute (NCI)

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2024
• Primary Completion (Actual): July 10, 2025
• Study Completion (Actual): July 10, 2025

Study Registration Dates

• First Submitted: March 1, 2024
• First Submitted That Met QC Criteria: March 14, 2024
• First Posted (Actual): March 21, 2024

Study Record Updates

• Last Update Posted (Actual): August 11, 2026
• Last Update Submitted That Met QC Criteria: August 6, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Colonic Diseases; Colonic Neoplasms; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Cognitive Behavioral Therapy; Mindfulness
• Other Study ID Numbers: STUDY2023-1359; U54CA202997 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No