Targeting Chronic Stress for Reducing Risk Factors for Colorectal Cancer

NCT06323421 | Completed

• 1 other identifier: STUDY2023-1359
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Mindfulness; Colon Cancer; Females

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (14)

• Body mass index

  Baseline and post-intervention at week 9

• Stress measure

  Baseline and post-intervention at week 9

• Fasting glucose

  Baseline and post-intervention at week 9

Study Arms (1)

Mindfulness

EXPERIMENTAL

8-week group and individual mindfulness training and practice

Behavioral: Mindfulness

Interventions

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.

Mindfulness

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Illinois at Chicago: lead

Study Sites (1)

University of Illinois Chicago

Chicago, Illinois, 60612, United States

Location

MeSH Terms

Conditions

Colonic Neoplasms

Interventions

Mindfulness

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 1, 2024
• First Posted: March 21, 2024
• Study Start: July 15, 2024
• Primary Completion: July 15, 2025
• Study Completion: August 31, 2025
• Last Updated: November 21, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)