Skip to main content
OpenTrials
Completed

NCT Number: NCT06323421

Targeting Chronic Stress for Reducing Risk Factors for Colorectal Cancer

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

45 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Illinois Chicago

Chicago, Illinois, 60612, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Mindfulness

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.

Primary outcomes

  1. Feasibility measures

    Time frame: Monitored across the duration of study and 8-week intervention

    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

  2. Acceptability

    Time frame: Week 4 and post-intervention at week 9

    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.

Other outcomes

  1. Body mass index

    Time frame: Baseline and post-intervention at week 9

    weight in kg divided by height in meters squared

  2. Stress measure

    Time frame: Baseline and post-intervention at week 9

    Hair cortisol concentration

  3. Fasting glucose

    Time frame: Baseline and post-intervention at week 9

    Measured in serum

  4. Gut microbiota composition

    Time frame: Baseline and post-intervention at week 9

    16S rRNA amplicon sequencing from stool

  5. Gut inflammation

    Time frame: Baseline and post-intervention at week 9

    Fecal calprotectin

  6. Adiposity

    Time frame: Baseline and post-intervention at week 9

    % body fat and visceral body fat area from whole body DEXA

  7. Epinephrine

    Time frame: Baseline and post-intervention at week 9

    From serum measured via mass spectrometry

  8. Norepinephrine

    Time frame: Baseline and post-intervention at week 9

    From serum measured via mass spectrometry

  9. Cortisol

    Time frame: Baseline and post-intervention at week 9

    From serum measured via mass spectrometry

  10. Resting heart rate

    Time frame: Baseline and post-intervention at week 9

    Measured with an electronic monitor

  11. Blood lipids

    Time frame: Baseline and post-intervention at week 9

    From serum - total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides

  12. Fasting insulin

    Time frame: Baseline and post-intervention at week 9

    From serum

  13. Hemoglobin A1c

    Time frame: Baseline and post-intervention at week 9

    From whole blood

  14. Systemic inflammation

    Time frame: Baseline and post-intervention at week 9

    C-reactive protein measured in serum

Sponsors and collaborators

Lead sponsor

University of Illinois at Chicago

Other

Registry information

Official study title

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

Acronym: MindCRC

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Mar 21, 2024
Registry last updated
Nov 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.