Meditation for Breast Cancer

Overseen By Melinda Epstein, PhD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Hoag Memorial Hospital Presbyterian

Must not be taking: Narcotics

Disqualifiers: Recurrent cancer, Major psychiatric, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 12 weeks

24 Participants Needed

Trial Summary

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 is best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Meditation, Mindfulness-Based Stress Reduction (MBSR), Mindfulness Meditation, Cognitive Behavioral Therapy (CBT) for breast cancer?

Research shows that mindfulness-based stress reduction (MBSR) can help reduce anxiety and depression and improve the quality of life in women with breast cancer. Studies have found that MBSR is effective in managing psychological stress compared to standard care. ^{1 2 3 4 5}

Is meditation safe for people with breast cancer?

Meditation, including Mindfulness-Based Stress Reduction (MBSR), is generally considered safe for people with breast cancer and other conditions, as it is a non-drug approach focused on stress management. ^{2 5 6 7 8}

How is the treatment of meditation unique for breast cancer?

Meditation, specifically mindfulness-based stress reduction (MBSR), is unique for breast cancer as it focuses on reducing psychological stress, anxiety, and depression through mindfulness practices, unlike traditional treatments that primarily target the physical aspects of cancer. ^{1 2 3 4 7}

What is the purpose of this trial?

The purpose of this study is to determine if a regular meditation and breath work practice started before surgery and continued through post-surgical recovery can improve anxiety and pain related to breast cancer and its treatment.

Eligibility Criteria

This trial is for English-speaking women aged 18 or older who are newly diagnosed with primary breast cancer or DCIS and will receive surgical treatment. They must not have a major psychiatric history, narcotic dependence, regular meditation practice in the past year, or be undergoing certain complex surgeries.

Inclusion Criteria

You are going to have surgery as the first treatment for your breast cancer.

Subject must be able to speak and read English

You are having surgery to remove breast cancer, with or without reconstruction.

Exclusion Criteria

You currently have or have had a serious mental health diagnosis.

You are currently receiving chemotherapy before surgery.

Re-excision after lumpectomy (subjects who require re-excision after initial enrollment will be excluded from final analysis and dropped from the study)

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Pre-surgery Education

Participants complete a one-on-one education session regarding meditation practice with a wellness coach and begin a daily meditation practice

1 week

1 visit (in-person)

Treatment

Participants engage in daily meditation and breath work practice for 12 weeks, maintaining a daily meditation log, medication log, and completing daily pain assessment questionnaire

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Meditation

Trial Overview The study tests if practicing meditation and breath work before and after surgery can reduce anxiety and pain in patients dealing with breast cancer treatments. Participants will start meditating before their surgery and continue during recovery.

Participant Groups

Group I: Meditation Experimental Treatment 1 Intervention

Two guided meditations will be provided to participants. They will be asked to meditate twice daily, once in the morning once before bed, for a total time of 12 minutes per day. Surgical treatment and postoperative care will be provided by surgeon preference and usual practice, including post-operative pain medications. For 12 weeks patients will maintain a daily meditation log, medication log and complete daily pain assessment questionnaire.

Meditation is already approved in United States, European Union for the following indications:

Approved in United States as Mindfulness Meditation for:

• Chronic Low Back Pain

Approved in European Union as Mindfulness-Based Stress Reduction (MBSR) for:

• Chronic Pain Management
• Stress Reduction

Who Is Running the Clinical Trial?

Hoag Memorial Hospital Presbyterian

Lead Sponsor

Trials

37

Recruited

17,200+

Findings from Research

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) 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]

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) and mindfulness-based cognitive therapy (MBCT) significantly improved health-related quality of life, fatigue, sleep, stress, anxiety, and depression in women with breast cancer, based on a meta-analysis of 10 studies involving 1709 participants.

While these interventions showed short-term effectiveness, the average effects were below the threshold for minimal clinically important differences, indicating that while beneficial, their clinical relevance may need further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-based interventions for women with breast cancer: an updated systematic review and meta-analysis. Haller, H., Winkler, MM., Klose, P., et al.[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]

A systematic review of 18 studies found that Mindfulness Based Stress Reduction (MBSR) therapy significantly improves the conditions of patients with chronic illnesses such as cancer, hypertension, and diabetes.

MBSR offers a promising alternative treatment method that helps patients manage their diseases more effectively, although more research is needed to fully understand its mechanisms and potential adverse effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-based stress reduction: a non-pharmacological approach for chronic illnesses. Niazi, AK., Niazi, SK.[2022]

Mindfulness-based stress reduction (MBSR) has shown a positive effect on reducing anxiety in women with breast cancer, as indicated by four out of six studies included in the review.

The impact of MBSR on quality of life and depression was less consistent, with only two studies showing positive effects on quality of life and half of the studies showing benefits for depression, suggesting the need for further research with larger sample sizes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can Mindfulness-Based Stress Reduction Influence the Quality of Life, Anxiety, and Depression of Women Diagnosed with Breast Cancer? -A Review. Ladenbauer, S., Singer, J.[2023]

Mindfulness-based stress reduction (MBSR) may slightly improve quality of life immediately after the intervention, but this effect does not persist in the long term, based on a systematic review of 14 randomized clinical trials involving 1,571 participants.

MBSR probably reduces anxiety and depression in the short term, with moderate-certainty evidence showing significant improvements, while its effects on fatigue and quality of sleep are less consistent over time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-based stress reduction for women diagnosed with breast cancer. Schell, LK., Monsef, I., Wöckel, A., et al.[2022]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

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

2. 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]

3. 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]

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

Mindfulness-based interventions for women with breast cancer: an updated systematic review and meta-analysis. [2022]

5. 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]

6. India pubmed.ncbi.nlm.nih.gov

Mindfulness-based stress reduction: a non-pharmacological approach for chronic illnesses. [2022]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Can Mindfulness-Based Stress Reduction Influence the Quality of Life, Anxiety, and Depression of Women Diagnosed with Breast Cancer? -A Review. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Mindfulness-based stress reduction for women diagnosed with breast cancer. [2022]