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. ^{1 2 3 4 5}

Is mindfulness safe for humans?

Mindfulness practices like Mindfulness-Based Stress Reduction (MBSR) and Mindfulness-Based Cognitive Therapy (MBCT) have been widely studied and are generally considered safe for humans, with no significant safety concerns reported in the research. ^{2 3 6 7 8}

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. ^{9 10 11 12 13}

Research Team

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

Exclusion Criteria

Consume > 50 grams of ethanol daily

Use combustible tobacco

I have had weight loss surgery or part of my bowel removed.

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 Overview The 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

Group I: Mindfulness Experimental Treatment 1 Intervention

8-week group and individual mindfulness training and practice

Mindfulness is already approved in Canada for the following indications:

Approved in Canada as Mindfulness-Based Cognitive Therapy for:

• Depression
• Anxiety Disorders
• Substance Abuse Treatment

Who Is Running the Clinical Trial?

University of Illinois at Chicago

Lead Sponsor

Trials

653

Recruited

1,574,000+

Mark I. Rosenblatt

University of Illinois at Chicago

Chief Executive Officer

MD, PhD, MBA, MHA

Jon Radosta

University of Illinois at Chicago

Chief Medical Officer since 2023

MD

Findings from Research

Mindfulness-based interventions (MBIs) significantly reduce psychological distress in cancer patients and survivors, with a small but meaningful effect size (Hedges's g = 0.32) observed immediately after the intervention and a sustained effect (g = 0.19) at follow-up, based on a systematic review of 29 randomized controlled trials involving 3274 participants.

MBIs also positively impact secondary outcomes such as anxiety, depression, and sleep disturbances, with larger effects noted in studies that adhered closely to MBI protocols and involved younger participants, indicating that optimizing these interventions could enhance their efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-based interventions for psychological and physical health outcomes in cancer patients and survivors: A systematic review and meta-analysis of randomized controlled trials. Cillessen, L., Johannsen, M., Speckens, AEM., et al.[2021]

In a study of 88 colorectal cancer patients undergoing chemotherapy, the addition of mindfulness-based stress reduction (MBSR) to standard care improved psychological well-being, treatment compliance, and self-care abilities compared to conventional care alone.

While the overall response rate and adverse events were similar between the MBSR and control groups, the MBSR group showed higher rates of improvement in functional status and quality of life after one year, indicating its potential benefit in enhancing patient rehabilitation during chemotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Efficacy of Bevacizumab Plus XELOX Chemotherapy in Colorectal Cancer and Application Value of Mindfulness-Based Stress Reduction Intervention. Sun, L., Zhang, X., Gong, P., et al.[2022]

Both group face-to-face mindfulness-based cognitive therapy (MBCT) and individual internet-based mindfulness-based cognitive therapy (eMBCT) led to long-term reductions in psychological distress and increases in mental health-related quality of life over a nine-month follow-up period for 245 distressed cancer patients.

Patients who participated in eMBCT reported lower psychological distress compared to those in MBCT, particularly benefiting those with lower baseline mindfulness and conscientiousness, suggesting that eMBCT may be a more effective option for certain individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Consolidation and prediction of long-term treatment effect of group and online mindfulness-based cognitive therapy for distressed cancer patients. Cillessen, L., Schellekens, MPJ., Van de Ven, MOM., et al.[2019]

Mindfulness-Based Stress Reduction (MBSR) shows promise in improving mood, sleep quality, and reducing stress in cancer patients, based on a systematic review of three randomized controlled trials and seven uncontrolled trials.

Despite positive outcomes, the review highlights methodological limitations, such as variations in study designs and a lack of controlled studies, indicating that more rigorous research is needed to firmly establish the efficacy and safety of MBSR for cancer supportive care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-Based Stress Reduction as supportive therapy in cancer care: systematic review. Smith, JE., Richardson, J., Hoffman, C., et al.[2018]

The study evaluated the effectiveness of a mindfulness-based stress reduction app in reducing anxiety and depression symptoms among colorectal cancer patients, but found no significant changes between the intervention and control groups.

Despite a slight trend towards reduced anxiety and depression in the intervention group, the overall low levels of these symptoms at baseline and the high average age of participants (65 years) may have limited the app's effectiveness, suggesting future studies should target younger patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness based intervention through mobile app for colorectal cancer people awaiting surgery: A randomized clinical trial. Rocamora González, C., Rodríguez Vega, B., Torrijos Zarcero, M., et al.[2022]

Colorectal cancer is often preventable, as it typically develops from adenomas, and early detection through methods like endoscopic polypectomy and fecal occult blood testing can significantly reduce mortality by 15-33%.

While dietary fiber's role in reducing colorectal cancer risk is uncertain, non-steroidal anti-inflammatory drugs (NSAIDs) show protective effects but carry risks, such as gastrointestinal bleeding, limiting their use; thus, targeted surveillance for high-risk individuals is crucial.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Review article: the prevention of colorectal cancer. Dove-Edwin, I., Thomas, HJ.[2019]

In a study of 150 asymptomatic participants in a colorectal cancer prevention program, over half showed psychosomatic syndromes, which were linked to higher psychological distress and unhealthy lifestyle behaviors like smoking and poor diet.

The presence of certain psychosomatic syndromes, particularly irritable mood, was significantly associated with the detection of adenomas during colonoscopy, suggesting that psychosocial assessments could enhance preventive strategies in colorectal cancer screening.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The clinical utility of a comprehensive psychosomatic assessment in the program for colorectal cancer prevention: a cross-sectional study. Gostoli, S., Montecchiarini, M., Urgese, A., et al.[2023]

Colorectal cancer (CRC) is a major cause of cancer-related deaths in the U.S., but it is largely preventable through various strategies, including understanding individual risk and following screening recommendations.

Lifestyle changes such as increasing dietary fiber, consuming more fruits and vegetables, reducing red meat intake, and maintaining a healthy weight can significantly lower the risk of developing CRC.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Colorectal cancer: what should patients and families be told to lower the risk of colorectal cancer? Moore, HG.[2010]

A review of 103 cohort studies found that high alcohol consumption significantly increases the risk of colorectal cancer by 60% compared to non-drinkers, highlighting the importance of moderating alcohol intake.

Other factors such as smoking, diabetes, obesity, and high meat consumption were also linked to a 20% increased risk of colorectal cancer, while physical activity was found to be protective, suggesting lifestyle changes could help reduce cancer incidence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of dietary and lifestyle risk factors on risk of colorectal cancer: a quantitative overview of the epidemiological evidence. Huxley, RR., Ansary-Moghaddam, A., Clifton, P., et al.[2022]

Colorectal cancer (CRC) can be effectively prevented and mortality reduced through various strategies, including lifestyle changes, chemoprevention, and endoscopic screening for high-risk and average-risk individuals.

Future CRC prevention will increasingly rely on personalized management that considers individual risk factors, such as genetics and lifestyle, to optimize detection and treatment strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Strategies for colon cancer prevention. Björk, J.[2021]

References

1. England pubmed.ncbi.nlm.nih.gov

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]

2. United States pubmed.ncbi.nlm.nih.gov

Clinical Efficacy of Bevacizumab Plus XELOX Chemotherapy in Colorectal Cancer and Application Value of Mindfulness-Based Stress Reduction Intervention. [2022]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Mindfulness-based stress reduction for breast cancer-a systematic review and meta-analysis. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Consolidation and prediction of long-term treatment effect of group and online mindfulness-based cognitive therapy for distressed cancer patients. [2019]

5. England pubmed.ncbi.nlm.nih.gov

Mindfulness-Based Stress Reduction as supportive therapy in cancer care: systematic review. [2018]

6. England pubmed.ncbi.nlm.nih.gov

Being mindful of mindfulness interventions in cancer: A systematic review of intervention reporting and study methodology. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Mindfulness-based stress reduction and mindfulness-based cognitive therapy: a systematic review of randomized controlled trials. [2022]

8. Spain pubmed.ncbi.nlm.nih.gov

Mindfulness based intervention through mobile app for colorectal cancer people awaiting surgery: A randomized clinical trial. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Review article: the prevention of colorectal cancer. [2019]

10. England pubmed.ncbi.nlm.nih.gov

The clinical utility of a comprehensive psychosomatic assessment in the program for colorectal cancer prevention: a cross-sectional study. [2023]

11. United States pubmed.ncbi.nlm.nih.gov

Colorectal cancer: what should patients and families be told to lower the risk of colorectal cancer? [2010]

12. United States pubmed.ncbi.nlm.nih.gov

The impact of dietary and lifestyle risk factors on risk of colorectal cancer: a quantitative overview of the epidemiological evidence. [2022]

13. Switzerland pubmed.ncbi.nlm.nih.gov

Strategies for colon cancer prevention. [2021]