Targeting Chronic Stress for Reducing Risk Factors for Colorectal Cancer (NCT06323421) | Clinical Trial Compass
CompletedNot Applicable
Targeting Chronic Stress for Reducing Risk Factors for Colorectal Cancer
United States24 participantsStarted 2024-07-15
Plain-language 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.
Who can participate
Age range
45 Years – 65 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Feasibility measures
Timeframe: Monitored across the duration of study and 8-week intervention