Clinical trial · Interventional
Targeting Chronic Stress for Reducing Risk Factors for Colorectal Cancer
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colon Cancer | Malignant Colon Neoplasm | CURATED_EXACT | 0.92 |
| Females | — | UNRESOLVED | — |
| Mindfulness | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Mindfulness | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Mindfulness
- description
- 8-week group and individual mindfulness training and practice
- interventionNames
- Behavioral: Mindfulness
Primary outcomes (2)
- measure
- Feasibility measures
- timeFrame
- Monitored across the duration of study and 8-week intervention
- description
- 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
- measure
- Acceptability
- timeFrame
- Week 4 and post-intervention at week 9
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 45 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available