Colon Cancer, Females, Mindfulness
Conditions
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.
Interventions
BEHAVIORALMindfulness
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.
Sponsors
University of Illinois at Chicago
National Cancer Institute (NCI)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
45 Years to 65 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility measures | 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 |
| Acceptability | 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. |
Countries
United States
Outcome results
None listed