University of Illinois Chicago
Chicago, Illinois, 60612, United States
NCT Number: NCT06323421
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.
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Notify Me45 year–65 year
Female
Interventional
Not applicable
Chicago, Illinois, 60612, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Monitored across the duration of study and 8-week intervention
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
Time frame: Week 4 and post-intervention at week 9
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.
Time frame: Baseline and post-intervention at week 9
weight in kg divided by height in meters squared
Time frame: Baseline and post-intervention at week 9
Hair cortisol concentration
Time frame: Baseline and post-intervention at week 9
Measured in serum
Time frame: Baseline and post-intervention at week 9
16S rRNA amplicon sequencing from stool
Time frame: Baseline and post-intervention at week 9
Fecal calprotectin
Time frame: Baseline and post-intervention at week 9
% body fat and visceral body fat area from whole body DEXA
Time frame: Baseline and post-intervention at week 9
From serum measured via mass spectrometry
Time frame: Baseline and post-intervention at week 9
From serum measured via mass spectrometry
Time frame: Baseline and post-intervention at week 9
From serum measured via mass spectrometry
Time frame: Baseline and post-intervention at week 9
Measured with an electronic monitor
Time frame: Baseline and post-intervention at week 9
From serum - total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides
Time frame: Baseline and post-intervention at week 9
From serum
Time frame: Baseline and post-intervention at week 9
From whole blood
Time frame: Baseline and post-intervention at week 9
C-reactive protein measured in serum
University of Illinois at Chicago
Other
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
Acronym: MindCRC
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