Mindfulness intervention to reduce colorectal cancer risk in Black women
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
This study is testing whether an 8-week mindfulness program can help reduce stress and lower the risk of colorectal cancer in Black women aged 45-65 living in high-stress neighborhoods.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 45 Years to 65 Years |
| Sex | Female |
| Sponsor | University of Illinois at Chicago Academic / other |
| Locations | 1 site (Chicago, Illinois) |
| Trial ID | NCT06323421 on ClinicalTrials.gov |
What this trial studies
This research aims to explore the impact of mindfulness practices on chronic psychosocial stress and its potential role in reducing colorectal cancer risk factors among Black American women aged 45-65. The study will pilot an 8-week mindfulness intervention delivered in a hybrid format to 40 participants who reside in high-stress neighborhoods in Chicago and report elevated stress levels. Participants will undergo assessments including blood and stool analysis, body composition, and lifestyle surveys before and after the intervention to evaluate its feasibility and preliminary effects on stress and health markers associated with colon cancer risk.
Who should consider this trial
Good fit: Ideal candidates are Black females aged 45-65 who have completed a colonoscopy in the past 24 months and are classified as elevated risk for colorectal cancer.
Not a fit: Patients with a history of colorectal cancer or significant health conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly lower colorectal cancer risk factors in a vulnerable population.
How similar studies have performed: While mindfulness interventions have shown promise in reducing stress, this specific approach targeting colorectal cancer risk in this demographic is novel.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Chicago, Illinois
- University of Illinois Chicago — Chicago, Illinois, United States (Recruiting)
Study contacts
- Study coordinator: Lisa Tussing, PhD
- Email: tussing@uic.edu
- Phone: 13123555521
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.