Mindfulness for Reducing Colorectal Cancer Risk

(MindCRC Trial)

No longer recruiting at 1 trial location

Overseen By Alana Biggers, MD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of Illinois at Chicago

Must not be taking: Antibiotics, Corticosteroids, others

Disqualifiers: History of CRC, Cancer, Diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how practicing mindfulness might lower the risk of colorectal cancer, particularly for Black American women in Chicago who experience significant daily stress. Researchers believe stress can impact the gut and immune system, potentially increasing cancer risk. Participants will engage in an 8-week mindfulness program to assess its effectiveness. Women who have had a colonoscopy in the last two years and reside in high-crime areas in Chicago are encouraged to join. As an unphased trial, this study provides a unique opportunity to contribute to groundbreaking research that could enhance stress management and cancer prevention strategies.

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 prior data suggests that mindfulness is safe for reducing colorectal cancer risk factors?

Research has shown that mindfulness is generally safe and easy to manage. Studies have found that it can lower stress, anxiety, and depression in cancer patients while boosting their overall quality of life. No reports of serious side effects from practicing mindfulness suggest it is a low-risk way to reduce stress and improve health. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for reducing colorectal cancer risk focus on lifestyle changes like diet, exercise, and regular screenings. But mindfulness training offers a unique approach by targeting stress reduction and mental well-being, which can indirectly influence physical health. Researchers are excited about mindfulness because it emphasizes holistic health and doesn't require medications or invasive procedures. This technique might empower individuals to manage stress better, potentially lowering cancer risk through improved overall health.

What evidence suggests that mindfulness might be an effective treatment for reducing colorectal cancer risk?

Research has shown that mindfulness practices can reduce stress, anxiety, and depression in cancer patients. These benefits are crucial as they support better health and recovery. One study found that an online mindfulness program benefited individuals with breast, prostate, or colorectal cancer, suggesting it might help reduce cancer risk factors. Another review found that mindfulness programs improve the quality of life for cancer patients. This trial will evaluate an 8-week mindfulness program to determine if it can lower the risk of colorectal cancer by managing stress and its effects on the body. ^{1 2 4 6 7}

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Mindfulness

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.

How Is the Trial Designed?

Group I: Mindfulness Experimental Treatment 1 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

Who Is Running the Clinical Trial?

University of Illinois at Chicago

Lead Sponsor

Trials

653

Recruited

1,574,000+

Published Research Related to This Trial

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]

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]

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]

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]

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]

Mindfulness-based stress reduction (MBSR) significantly reduces depression and anxiety in breast cancer patients compared to usual care, based on a systematic review of three randomized controlled trials involving 327 subjects.

While MBSR shows promise in improving psychological health, it does not significantly increase spirituality, indicating that its benefits may be more focused on mental health rather than spiritual well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-based stress reduction for breast cancer-a systematic review and meta-analysis. Cramer, H., Lauche, R., Paul, A., et al.[2021]

Mindfulness-Based Stress Reduction (MBSR) has been shown to improve mental health in 11 studies compared to waitlist controls or treatment as usual, demonstrating its efficacy as a therapeutic intervention.

Mindfulness-Based Cognitive Therapy (MBCT) effectively reduces the risk of depressive relapse, showing similar efficacy to treatment as usual in two studies, indicating its potential as a preventive measure for depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-based stress reduction and mindfulness-based cognitive therapy: a systematic review of randomized controlled trials. Fjorback, LO., Arendt, M., Ornbøl, E., et al.[2022]

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]

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]

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]

A review of 30 studies on mindfulness interventions for cancer patients found that none strictly adhered to standardized protocols for mindfulness-based stress reduction (MBSR), with many using modified versions that lacked proper documentation.

Despite claims of benefits from mindfulness interventions in cancer care, the variability in study designs and modifications raises concerns about their efficacy, as many studies reported only minor improvements in supportive care symptoms rather than significant relief from psychological disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Being mindful of mindfulness interventions in cancer: A systematic review of intervention reporting and study methodology. Shaw, JM., Sekelja, N., Frasca, D., et al.[2019]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5221754/

Randomized Controlled Pilot Trial of Mindfulness-Based ... MBSR focused on mindfulness training; PES focused on CRF self-management. Outcomes included CRF interference (primary), CRF severity and global improvement, ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S0022399925002764

Mindfulness-based interventions for cancer patients in ... Studies synthesized in this meta-analysis showed that MBIs have positive outcomes, namely increased quality of life, and reduced depression and anxiety symptoms ...

3. withpower.com withpower.com/trial/phase-females-3-2024-6d6a2

Mindfulness 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.

4. thelancet.com thelancet.com/journals/eclinm/article/PIIS2589-5370(25)00305-0/fulltext

Efficacy of an online mindfulness program (MindOnLine) to ... This study reports on the efficacy of MindOnLine, an online mindfulness program, for people living with–and beyond–breast, prostate or colorectal cancer, in ...

5. waocp.com waocp.com/journal/index.php/apjcc/article/view/686

Mindfulness Based Therapy in Cancer Patients: Meta- ... The present meta-analytic study aimed to examine the effects of mindfulness-based programmes on anxiety, and depression in cancer infected and survivors.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6371675/

A Systematic Review: Mindfulness Intervention for Cancer ... Study outcomes include improved pain severity, anxiety, stress, depression, and QoL. However, most studies reviewed were conducted in the United States and ...

7. mdpi.com mdpi.com/2077-0383/14/5/1703

Mindfulness-Based Cognitive Therapy in Clinical Practice MBCT is a clinical intervention that integrates cognitive therapy with mindfulness practices to prevent depression relapses and improve mental health.