Mindfulness for Reducing Colorectal Cancer Risk
(MindCRC Trial)
Recruiting in Palo Alto (17 mi)
+1 other location
Age: 18+
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Illinois at Chicago
Must not be taking: Antibiotics, Corticosteroids, others
Disqualifiers: History of CRC, Cancer, Diabetes, others
No Placebo Group
Approved in 3 Jurisdictions
Trial Summary
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial does not specify if you must stop taking your current medications, but it excludes those taking certain medications like β-blockers and corticosteroids. It's best to discuss your specific medications with the trial team.
What data supports the effectiveness of the treatment Mindfulness-Based Interventions for reducing colorectal cancer risk?
Research shows that mindfulness-based interventions can help reduce psychological distress in cancer patients, which may support overall health and recovery. Specifically, mindfulness-based stress reduction has been used effectively alongside chemotherapy in colorectal cancer care to improve patient outcomes.12345
Is mindfulness safe for humans?
How does the treatment Mindfulness differ from other treatments for reducing colorectal cancer risk?
Mindfulness is unique because it focuses on reducing stress and improving mental well-being, which can lead to healthier lifestyle choices that may lower colorectal cancer risk. Unlike traditional treatments that involve drugs or invasive procedures, mindfulness uses techniques like meditation and cognitive therapy to promote overall health and potentially prevent cancer.910111213
Eligibility Criteria
This trial is for Black American women at an elevated risk of colorectal cancer who live in high-stress neighborhoods in Chicago. Participants should be interested in practicing mindfulness to potentially reduce their cancer risk.Inclusion Criteria
Self-identify as Black
Completed a colonoscopy in the past 12 months
Score ≥ 14 on the PSS at screening
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Exclusion Criteria
Consume > 50 grams of ethanol daily
Use combustible tobacco
I have had weight loss surgery or part of my bowel removed.
See 9 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Mindfulness Intervention
Participants undergo an 8-week mindfulness intervention delivered in a hybrid format, including both group and individual mindfulness training and practice.
8 weeks
Synchronous and asynchronous sessions
Follow-up
Participants are monitored for changes in stress, weight, glucose, inflammation markers, and gut microbiome composition after the intervention.
1 week
Post-intervention assessments
Treatment Details
Interventions
- Mindfulness (Behavioral Intervention)
Trial OverviewThe study is testing whether practicing mindfulness can help lower chronic psychosocial stress (CPS) and, as a result, reduce the risk factors associated with colorectal cancer development.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: MindfulnessExperimental Treatment1 Intervention
8-week group and individual mindfulness training and practice
Mindfulness is already approved in United States, European Union, Canada for the following indications:
🇺🇸 Approved in United States as Mindfulness-Based Interventions for:
- Substance Abuse Treatment
- Anxiety Disorders
- Depression
🇪🇺 Approved in European Union as Mindfulness-Based Stress Reduction for:
- Stress Management
- Anxiety Disorders
- Chronic Pain
🇨🇦 Approved in Canada as Mindfulness-Based Cognitive Therapy for:
- Depression
- Anxiety Disorders
- Substance Abuse Treatment
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of Illinois ChicagoChicago, IL
University of Illinois at ChicagoChicago, IL
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Who Is Running the Clinical Trial?
University of Illinois at ChicagoLead Sponsor
References
Mindfulness-based interventions for psychological and physical health outcomes in cancer patients and survivors: A systematic review and meta-analysis of randomized controlled trials. [2021]Mindfulness-based interventions (MBIs) are increasingly used within psycho-oncology. Since the publication of the most recent comprehensive meta-analysis on MBIs in cancer in 2012, the number of published trials has more than doubled. We therefore conducted a systematic review and meta-analysis of randomized controlled trials (RCTs), testing the efficacy of MBIs on measures of psychological distress (primary outcome) and other health outcomes in cancer patients and survivors.
Clinical Efficacy of Bevacizumab Plus XELOX Chemotherapy in Colorectal Cancer and Application Value of Mindfulness-Based Stress Reduction Intervention. [2022]Colorectal cancer (CRC) is a malignant tumor with an extremely high incidence rate worldwide. This study explores the influence of mindfulness-based stress reduction (MBSR) in the care of patients with CRC undergoing bevacizumab (BVZ) plus XELOX chemotherapy, aiming at providing reliable reference and guidance for further improving their rehabilitation and prognosis.
Mindfulness-based stress reduction for breast cancer-a systematic review and meta-analysis. [2021]The aim of this systematic review and meta-analysis was to assess the effectiveness of mindfulness-based stress reduction (mbsr) and mindfulness-based cognitive therapy (mbct) in patients with breast cancer.
Consolidation and prediction of long-term treatment effect of group and online mindfulness-based cognitive therapy for distressed cancer patients. [2019]Group face-to-face and individual internet-based mindfulness-based cognitive therapy (MBCT and eMBCT) have been demonstrated to reduce psychological distress for distressed cancer patients in a randomized controlled trial (RCT). This study focused on the long-term effects of this RCT during the nine-month follow-up period, and on possible predictors, moderators and working mechanisms.
Mindfulness-Based Stress Reduction as supportive therapy in cancer care: systematic review. [2018]This paper reports a systematic review and critical appraisal of the evidence on the effectiveness of Mindfulness-Based Stress Reduction for cancer supportive care.
Being mindful of mindfulness interventions in cancer: A systematic review of intervention reporting and study methodology. [2019]While mindfulness-based stress reduction (MBSR) and mindfulness-based cognitive therapy (MBCT) have demonstrated efficacy in clinical populations, the potential therapeutic benefit of mindfulness in the context of cancer is less clear. The aim of this review was to critically appraise mindfulness intervention reporting and study methodology.
Mindfulness-based stress reduction and mindfulness-based cognitive therapy: a systematic review of randomized controlled trials. [2022]Fjorback LO, Arendt M, Ørnbøl E, Fink P, Walach H. Mindfulness-Based Stress Reduction and Mindfulness-Based Cognitive Therapy - a systematic review of randomized controlled trials.
Mindfulness based intervention through mobile app for colorectal cancer people awaiting surgery: A randomized clinical trial. [2022]Colorectal cancer is the third most common cancer worldwide both in men and women. Around one-third of patients with cancer will suffer from anxiety or depression symptoms. The aim of this study was to evaluate the effectiveness of a Mindfulness-based stress reduction intervention through a mobile application ("En Calma en el Quirófano").
Review article: the prevention of colorectal cancer. [2019]Colorectal cancer is a leading cause of cancer mortality in the industrialized world. Survival remains poor because most cases are diagnosed at an advanced stage. It is a preventable disease as colorectal cancers usually develop slowly from an identifiable precursor lesion, the adenoma. The existing strategies for colorectal cancer prevention include dietary prevention, chemoprevention and endoscopic intervention. The exact relationship between diet, particularly fibre, and colorectal cancer remains unclear, with the most recent studies suggesting that dietary fibre may not decrease colorectal cancer risk as previously thought. Non-steroidal anti-inflammatory drugs have been shown to have a protective effect against colorectal cancer, but the adverse effect profile of the non COX-2 selective drugs, particularly the risk of gastrointestinal haemorrhage, precludes their widespread use. There is increasing evidence that colorectal cancer incidence and mortality can be decreased from endoscopic polypectomy and early detection of cancer. Faecal occult blood testing in the general population ('average-risk') has been shown in randomized trials to decrease mortality from colorectal cancer by 15--33%. Long-term results of randomized trials of the effectiveness of flexible sigmoidoscopy and colonoscopy screening in the general population are awaited. Targeting high risk individuals may also be an effective and efficient way to decrease the colorectal cancer burden. As many as 15--30% of colorectal cases may be due to hereditary factors. Individuals with one or two direct relatives affected are at moderate risk for colorectal cancer (empirical lifetime mortality from colorectal cancer approximately 10%) and approximately 2--3% of cases arise in individuals harbouring highly penetrant autosomal dominant mutations, which puts them at high-risk for colorectal cancer. Surveillance colonoscopy is offered to individuals at moderate and high risk for colorectal cancer.
The clinical utility of a comprehensive psychosomatic assessment in the program for colorectal cancer prevention: a cross-sectional study. [2023]Few studies have investigated psychosocial characteristics and lifestyle behaviors of participants at programs for secondary prevention of colorectal cancer (CRC). This study aimed, through a comprehensive psychosomatic assessment based on clinimetric principles, to evaluate psychosocial characteristics and lifestyle behaviors in participants at CRC secondary prevention program, and to investigate the associations between these variables and endoscopic outcomes. In this cross-sectional study, the first 150 consecutive asymptomatic participants at the CRC prevention program who resulted positive to fecal occult blood test (FOBT) and were thus referred to colonoscopy, underwent a psychosomatic assessment including psychiatric diagnoses (DSM-5), psychosomatic syndromes (DCPR-R), psychological distress, psychological well-being and lifestyle behaviors. Whereas only 5.3% of the sample showed at least one DSM-5 diagnosis, 51.3% showed at least one DCPR syndrome, such as allostatic overload, alexithymia, Type A behavior, and demoralization. Patients affected by psychosomatic syndromes presented with significantly higher psychological distress, lower psychological well-being and unhealthy lifestyle behaviors, such as tobacco smoking and unhealthy diet, in comparison with patients without DCPR syndromes. Among endoscopic outcomes, the presence of adenomas was significantly associated with DCPR irritable mood. In a clinical context of secondary prevention addressing asymptomatic patients with positive FOBT, a comprehensive psychosomatic assessment may provide relevant clinical information for those patients who present certain psychosomatic syndromes associated with high psychological distress, impaired psychological well-being, unhealthy lifestyle behaviors and colorectal precancerous lesions. The results of the present study indicate a road to the practice of "preventive" medicine at CRC screening program.
Colorectal cancer: what should patients and families be told to lower the risk of colorectal cancer? [2010]Colorectal cancer (CRC) is the second most common cause of cancer-related death in the United States. CRC, however, is potentially preventable, and several strategies may be employed to decrease the incidence of and mortality from CRC. Understanding of individual risk and adherence to screening and surveillance recommendations undoubtedly will reduce CRC-associated deaths. Several natural and synthetic chemopreventive agents may prove effective for both primary and secondary CRC chemoprevention. Finally, dietary modifications (ie, increased dietary fiber, fruits and vegetables, and decreased red meat) and other lifestyle changes (i.e., increased physical activity, weight maintenance, avoidance of smoking, and moderation of alcohol intake) also may lower the risk of developing CRC.
The impact of dietary and lifestyle risk factors on risk of colorectal cancer: a quantitative overview of the epidemiological evidence. [2022]Colorectal cancer is a major cause of cancer mortality and is considered to be largely attributable to inappropriate lifestyle and behavior patterns. The purpose of this review was to undertake a comparison of the strength of the associations between known and putative risk factors for colorectal cancer by conducting 10 independent meta-analyses of prospective cohort studies. Studies published between 1966 and January 2008 were identified through EMBASE and MEDLINE, using a combined text word and MESH heading search strategy. Studies were eligible if they reported estimates of the relative risk for colorectal cancer with any of the following: alcohol, smoking, diabetes, physical activity, meat, fish, poultry, fruits and vegetables. Studies were excluded if the estimates were not adjusted at least for age. Overall, data from 103 cohort studies were included. The risk of colorectal cancer was significantly associated with alcohol: individuals consuming the most alcohol had 60% greater risk of colorectal cancer compared with non- or light drinkers (relative risk 1.56, 95% CI 1.42-1.70). Smoking, diabetes, obesity and high meat intakes were each associated with a significant 20% increased risk of colorectal cancer (compared with individuals in the lowest categories for each) with little evidence of between-study heterogeneity or publication bias. Physical activity was protective against colorectal cancer. Public-health strategies that promote modest alcohol consumption, smoking cessation, weight loss, increased physical activity and moderate consumption of red and processed meat are likely to have significant benefits at the population level for reducing the incidence of colorectal cancer.
Strategies for colon cancer prevention. [2021]Colorectal cancer (CRC) is common and is associated with a considerable mortality. Morbidity and thereby mortality can be reduced by using different prevention strategies such as lifestyle interventions and chemoprevention. Endoscopic surveillance of high-risk individuals and population-based endoscopic screening of average-risk individuals enables detection and removal of premalignant lesions (adenomas) as well as presymptomatic detection of cancer. Implementation of cancer detection tests such as fecal occult blood tests (FOBTs) is another strategy to reduce cancer mortality by early detection of CRC. Personalized management, based on estimates of the individual risk using information concerning environmental factors, lifestyle, family history, personality, social background and phenotype in combination with a variety of biomarkers such as genotype, will become more important as a strategy to optimize CRC prevention in the future.