Mindfulness for Chemo-Brain in Breast Cancer

Overseen By Ana maria Lopez, MD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Thomas Jefferson University

Disqualifiers: Under 18, Cannot consent

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

Compensation: Varies

Number of Visits: 8

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether mindfulness, a meditation practice that helps people stay present and reduce stress, can prevent "chemo-brain" in women with breast cancer about to start chemotherapy. "Chemo-brain" describes cognitive issues like memory problems and difficulty concentrating that some people experience after chemotherapy. Participants will join a mindfulness program that includes activities like mindful breathing and meditation for eight weeks. Women preparing for chemotherapy after a breast cancer diagnosis may be a good fit for this study. As an unphased trial, this study offers a unique opportunity to explore innovative ways to improve quality of life during cancer treatment.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this mindfulness intervention is safe for preventing chemo-brain?

Research has shown that mindfulness practices are generally safe for breast cancer patients. These methods, tested in various settings, have demonstrated benefits such as improved focus and reduced stress. Studies indicate that mindfulness can enhance thinking skills in breast cancer survivors without major side effects.

Mindfulness involves being aware and present, which can boost well-being. These practices are typically easy to tolerate, and no serious negative effects have been widely reported. This makes mindfulness a promising option for those seeking to safely manage chemo-brain symptoms. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about mindfulness intervention for chemo-brain in breast cancer patients because it offers a non-pharmaceutical approach to managing cognitive difficulties. Unlike traditional options like cognitive rehabilitation therapy or medications that can have side effects, mindfulness focuses on enhancing present-moment awareness through activities like mindful breathing and body scans. This technique not only targets cognitive function but also potentially improves overall mental well-being, making it a holistic approach to care. Additionally, the use of tools like fMRI to monitor changes in brain activity provides a cutting-edge way to understand its effectiveness.

What evidence suggests that mindfulness is effective for preventing chemo-brain in breast cancer patients?

This trial will evaluate the effectiveness of a mindfulness program for managing "chemo-brain" in breast cancer patients. Studies have shown that mindfulness practices can enhance thinking and memory in cancer patients. Research suggests these practices might improve perceived memory, even if tests don't always reflect a change. Mindfulness is also associated with better quality of life and reduced depression and anxiety in cancer patients. Early findings indicate it can aid focus and concentration, potentially easing some chemotherapy side effects. Overall, mindfulness could be a valuable tool for managing "chemo-brain" in breast cancer patients. ^{1 4 5 6 7}

Are You a Good Fit for This Trial?

This trial is for women preparing to undergo chemotherapy for breast cancer. It aims to see if mindfulness meditation can prevent 'chemo-brain', a condition where patients experience cognitive issues after chemo.

Inclusion Criteria

I have breast cancer and am about to start chemotherapy.

Exclusion Criteria

I am unable to understand and agree to the study's details on my own.

I am under 18 years old.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Mindfulness Intervention

Participants engage in an 8-week mindfulness program including topics such as mindfulness of breathing, body scan, mindful eating, and more. Blood samples and fMRI are also conducted.

8 weeks

8 visits (in-person, weekly)

Follow-up

Participants are monitored for cognitive function, quality of life, and other factors 3 months after the intervention.

3 months

What Are the Treatments Tested in This Trial?

Interventions

• Mindfulness Intervention

Trial Overview The study tests a mindfulness intervention against the occurrence of 'chemo-brain'. Participants will practice mindfulness, have their brain structure and function assessed via MRI, and complete questionnaires about their cognitive function.

How Is the Trial Designed?

Group I: Supportive care (mindfulness program) Experimental Treatment 4 Interventions

Patients participate in a mindfulness program composed of topics that include mindfulness of breathing and the body scan, mindful eating, mindful activity, mindfulness in daily life, expanding the field of awareness, and maintaining a flexible mindfulness practice weekly over 2.5 hours for 8 weeks. Patients also undergo blood sample collection and fMRI on the study.

Who Is Running the Clinical Trial?

Thomas Jefferson University

Lead Sponsor

Trials

475

Recruited

189,000+

Published Research Related to This Trial

Mindfulness-based interventions (MBIs) significantly reduce symptoms of depression, anxiety, and cancer-related fatigue (CRF) in cancer patients, with medium effect sizes maintained for at least three months after the intervention.

In a review of 36 studies involving 1,677 participants, MBIs were found to be more effective than control groups in alleviating anxiety and CRF symptoms, highlighting their potential as a valuable component of oncological treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of mindfulness-based interventions on symptoms of depression, anxiety, and cancer-related fatigue in oncology patients: A systematic review and meta-analysis. Chayadi, E., Baes, N., Kiropoulos, L.[2022]

Mindfulness-based stress reduction (MBSR) significantly reduced psychological stress, anxiety, and depression in breast cancer patients compared to standard care, based on a review of 14 studies involving 2,224 participants.

While MBSR improved sleep quality, it did not have a significant impact on fatigue or overall quality of life, indicating that while it is beneficial for certain psychological aspects, its effects on physical well-being may be limited.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The efficacy of mindfulness-based stress reduction vs. standard or usual care in patients with breast cancer: a systematic review and meta-analysis of randomized controlled trials. Wu, H., Li, F., Zhang, F.[2022]

Mindfulness-Based Stress Reduction (MBSR) therapy significantly improved anxiety and depression scores in 106 breast cancer patients undergoing postoperative chemotherapy compared to a control group of 111 patients receiving routine nursing.

The MBSR intervention positively impacted the overall quality of life, particularly in psychological aspects, although it did not show significant effects on physiological health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Research on Mindfulness-Based Stress Reduction in Breast Cancer Patients Undergoing Chemotherapy: An Observational Pilot Study. Wang, H., Yang, Y., Zhang, X., et al.[2023]

An 8-week mindfulness-based stress reduction (MBSR) program significantly reduced anxiety and depression levels in 336 women with breast cancer, showing clinically meaningful effects after 12 months.

The intervention group experienced medium-to-large effect sizes in anxiety and depression improvements, particularly among those with higher baseline levels of these symptoms, indicating that MBSR can be an effective supportive therapy for breast cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness significantly reduces self-reported levels of anxiety and depression: results of a randomised controlled trial among 336 Danish women treated for stage I-III breast cancer. Würtzen, H., Dalton, SO., Elsass, P., et al.[2022]

Mindfulness-based stress reduction (MBSR) has shown large effect sizes in reducing perceived stress and state anxiety among breast cancer survivors, based on a review of 16 quantitative studies.

While MBSR had smaller effects on biological outcomes, it significantly improved cytokine production at 6- and 12-month follow-ups, suggesting potential long-term benefits for immune function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-based stress reduction among breast cancer survivors: a literature review and discussion. Matchim, Y., Armer, JM., Stewart, BR.[2022]

Mindfulness-based stress reduction (MBSR) significantly improves various aspects of health in breast cancer patients, including emotional well-being, cognitive function, and reduces anxiety and depression, based on a systematic review of 14 studies with 1505 participants.

MBSR is recommended as a complementary treatment for breast cancer patients, although its effects on pain, sleep quality, and overall quality of life were not statistically significant.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of mindfulness-based stress reduction (MBSR) on symptom variables and health-related quality of life in breast cancer patients-a systematic review and meta-analysis. Zhang, Q., Zhao, H., Zheng, Y.[2020]

The 4-week internet-delivered mindfulness-based cancer recovery (iMBCR) program significantly reduced symptom burden in breast cancer patients compared to a control group, with improvements maintained one month after the intervention.

Participants in the iMBCR group also experienced significant enhancements in health-related quality of life (HRQoL), indicating that this online program is an effective and accessible alternative to traditional mindfulness interventions for cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of a 4-Week Internet-Delivered Mindfulness-Based Cancer Recovery Intervention on the Symptom Burden and Quality of Life of Patients With Breast Cancer: Randomized Controlled Trial. Wang, L., Chen, X., Peng, Y., et al.[2022]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7092531/

A mindfulness-based intervention for breast cancer ... The aim of the present study protocol is to evaluate the efficacy and mechanisms of a mindfulness-based intervention to reduce cognitive impairment in breast ...

2. acsjournals.onlinelibrary.wiley.com acsjournals.onlinelibrary.wiley.com/doi/full/10.1002/cncr.34209

Mindfulness‐based stress reduction and cognitive function ... These results suggest that MBSR training reduces subjective (but not objective) memory-related impairments in BC survivors who receive treatment ...

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

Mindfulness-based interventions for cancer patients in ... Mindfulness interventions may improve quality of life in patients with cancer. Mindfulness interventions may decrease cancer-related depression and anxiety.

4. journals.lww.com journals.lww.com/jporp/fulltext/2023/01000/mindfulness_based_interventions_and_cognitive.4.aspx

Mindfulness-based interventions and cognitive function in... MBIs demonstrated evidence for improving cognitive function among cancer survivors and particularly self-reported cognitive function.

5. trialsjournal.biomedcentral.com trialsjournal.biomedcentral.com/articles/10.1186/s13063-020-4204-8

A mindfulness-based intervention for breast cancer patients ... The aim of the present study protocol is to evaluate the efficacy and mechanisms of a mindfulness-based intervention to reduce cognitive impairment in breast ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6260900/

Mindfulness-based interventions and cognitive function ... Mindfulness-based interventions have shown some evidence for improving cognition among breast cancer survivors.

7. acsjournals.onlinelibrary.wiley.com acsjournals.onlinelibrary.wiley.com/doi/full/10.1002/cncr.34640

The impact of mindfulness on cancer‐related cognitive ... In this study, the potential of a mindfulness-based intervention to reduce CRCI in breast cancer survivors, compared with physical training and a wait list ...