Clinical trial NCT06323421: Targeting Chronic Stress for Reducing Risk Factors for Colorectal Cancer
Official 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mindfulness
Colon Cancer
Females
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
First posted: 2024-03-21
Enrollment: 40
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

Detailed description: 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.

Eligibility 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)

Primary outcomes:
measure: Feasibility measures
timeFrame: Monitored across the duration of study and 8-week intervention
measure: Acceptability
timeFrame: Week 4 and post-intervention at week 9
Secondary outcomes:
Other outcomes:
measure: Body mass index
timeFrame: Baseline and post-intervention at week 9
measure: Stress measure
timeFrame: Baseline and post-intervention at week 9
measure: Fasting glucose
timeFrame: Baseline and post-intervention at week 9
measure: Gut microbiota composition
timeFrame: Baseline and post-intervention at week 9
measure: Gut inflammation
timeFrame: Baseline and post-intervention at week 9
measure: Adiposity
timeFrame: Baseline and post-intervention at week 9
measure: Epinephrine
timeFrame: Baseline and post-intervention at week 9
measure: Norepinephrine
timeFrame: Baseline and post-intervention at week 9
measure: Cortisol
timeFrame: Baseline and post-intervention at week 9
measure: Resting heart rate
timeFrame: Baseline and post-intervention at week 9
measure: Blood lipids
timeFrame: Baseline and post-intervention at week 9
measure: Fasting insulin
timeFrame: Baseline and post-intervention at week 9
measure: Hemoglobin A1c
timeFrame: Baseline and post-intervention at week 9
measure: Systemic inflammation
timeFrame: Baseline and post-intervention at week 9
Locations:
city: Chicago
country: United States
facility: University of Illinois Chicago
state: Illinois
Study officials:
References: