Mindfulness for Chemo-Brain in Breast Cancer

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Thomas Jefferson University

Disqualifiers: Under 18, Cannot consent

No Placebo Group

Trial Summary

What is the purpose of this trial?

This clinical trial tests how well a mindfulness intervention helps the prevention of chemotherapy-brain (chemo-brain) in women preparing for chemotherapy for breast cancer. Cognitive dysfunction after chemotherapy has been well-documented. Factors that have been used to document and/or have been correlated with chemo brain include self-report and structural brain changes including volume loss. Mindfulness is a type of meditation practice that can be learned to support well-being and decrease stress. Mindfulness is an approach that helps the person increase their awareness of the present moment without judgement. There are data that mindfulness may increase attention and concentration which may prevent some of the side effects from chemotherapy

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 data supports the effectiveness of the treatment Mindfulness Intervention, Brief Mindfulness-Based Intervention (BMBI), Mindfulness-Based Stress Reduction (MBSR), Mindfulness-Based Cognitive Training for chemo-brain in breast cancer?

Research shows that mindfulness-based treatments like MBSR can help reduce symptoms of depression, anxiety, and fatigue in cancer patients, which may indirectly support their use for managing chemo-brain in breast cancer patients. ^{1 2 3 4 5}

Is mindfulness safe for breast cancer patients?

Mindfulness-based interventions, like Mindfulness-Based Stress Reduction (MBSR), have been studied in cancer patients and are generally considered safe. They are used to help with emotional and physical well-being, and no significant safety concerns have been reported in the research. ^{1 2 3 6 7}

How does the mindfulness treatment for chemo-brain in breast cancer differ from other treatments?

Mindfulness-based interventions (MBIs) are unique because they focus on improving mental well-being through practices like meditation and stress reduction, rather than using medication. These treatments are often more accessible, as they can be delivered online and in shorter formats, making them convenient for cancer patients who may have difficulty attending in-person sessions. ^{1 2 4 7 8}

Research Team

Eligibility Criteria

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.

I am 18 years old or older.

Exclusion Criteria

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

I am under 18 years old.

Trial Timeline

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

Treatment Details

Interventions

• Mindfulness Intervention (Behavioural 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.

Participant Groups

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+

Dr. Eugene Kennedy

Thomas Jefferson University

Chief Medical Officer since 2020

MD

Dr. Joseph G. Cacchione

Thomas Jefferson University

Chief Executive Officer since 2022

MD, MBA

Findings from Research

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 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]

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]

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]

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]

References

1. Germany 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. [2020]

2. United States 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. [2022]

3. China 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. [2022]

4. 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]

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

Research on Mindfulness-Based Stress Reduction in Breast Cancer Patients Undergoing Chemotherapy: An Observational Pilot Study. [2023]

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

Mindfulness-based stress reduction among breast cancer survivors: a literature review and discussion. [2022]

7. Canada 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. [2022]

8. England 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. [2022]