Targeting Chronic Stress for Reducing Risk Factors for Colorectal Cancer

Colon Cancer Clinical Trial

— MindCRC  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06323421
• Other study ID #: STUDY2023-1359
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 22, 2024
• Est. completion date: August 31, 2025

Study information

• Verified date: March 2024
• Source: University of Illinois at Chicago
• Contact: Lisa Tussing, PhD
• Phone: 13123555521
• Email: tussing[@]uic.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: August 31, 2025
• Est. primary completion date: April 15, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 45 Years to 65 Years

Eligibility

Inclusion Criteria:

• Female based on sex assigned at birth
• Self-identify as Black
• Age 45-65 years old
• Completed a colonoscopy in the past 12 months,
• Classify as elevated risk of CRC defined as = 3 colorectal adenomas or one colorectal adenoma > 1 cm in the past 12 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., ß-blocker, Cushing's syndrome, and corticosteroids - inhaled, topical, oral in the past month given effects on hair cortisol measurement)

Related Conditions & MeSH terms

• Colon Cancer
• Colorectal Neoplasms
• Females
• Mindfulness

Intervention

Behavioral:
• Mindfulness
Participants attend seven 1-hour 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.

Locations

Country	Name	City	State
United States	University of Illinois at Chicago	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Illinois at Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Body mass index	weight in kg divided by height in meters squared	Baseline and post-intervention at week 9
Other	Stress measure	Hair cortisol concentration	Baseline and post-intervention at week 9
Other	Fasting glucose	Measured in serum	Baseline and post-intervention at week 9
Other	Gut microbiota composition	16S rRNA amplicon sequencing from stool	Baseline and post-intervention at week 9
Other	Gut inflammation	Fecal calprotectin	Baseline and post-intervention at week 9
Other	Adiposity	% body fat and visceral body fat area from whole body DEXA	Baseline and post-intervention at week 9
Other	Epinephrine	From serum measured via mass spectrometry	Baseline and post-intervention at week 9
Other	Norepinephrine	From serum measured via mass spectrometry	Baseline and post-intervention at week 9
Other	Cortisol	From serum measured via mass spectrometry	Baseline and post-intervention at week 9
Other	Resting heart rate	Measured with an electronic monitor	Baseline and post-intervention at week 9
Other	Blood lipids	From serum - total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides	Baseline and post-intervention at week 9
Other	Fasting insulin	From serum	Baseline and post-intervention at week 9
Other	Hemoglobin A1c	From whole blood	Baseline and post-intervention at week 9
Other	Systemic inflammation	C-reactive protein measured in serum	Baseline and post-intervention at week 9
Primary	Feasibility measures	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	Monitored across the duration of study and 8-week intervention
Primary	Acceptability	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.	Week 4 and post-intervention at week 9