Meditation Therapy for Cancer-Related Anxiety and Depression

Overseen By Gabriel Lopez-Berestein

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

Must be taking: Anxiety medications

Disqualifiers: Schizophrenia, Neurological disorders, 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

Duration: 2 weeks

35 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial studies how well self-administered meditation therapy works in improving anxiety and depression in cancer patients who exhibit psychosocial distress. Meditation therapy is a mind-body approach that uses a variety of techniques, such as deep breathing, sound, or movement, that may help to decrease distress and anxiety and enhance the health and quality of life of patients with cancer.

Do I need to stop my current medications to join the trial?

If you are taking medication for anxiety, you need to have been on a stable dose for at least six weeks before joining the trial and should not plan to change medications in the next four weeks. You can adjust the dose within the same type of medication, but switching to a different type of medication is not allowed.

What data supports the effectiveness of the treatment Meditation Therapy for reducing anxiety and depression in cancer patients?

Research shows that mindfulness-based stress reduction (MBSR), a key part of meditation therapy, significantly reduces anxiety and depression in breast cancer patients. Studies have found that MBSR helps improve the quality of life and mental well-being for those undergoing cancer treatment. ^{1 2 3 4 5}

Is meditation therapy safe for humans?

Meditation therapies like Mindfulness-Based Stress Reduction (MBSR) have been used safely in people with various conditions, including cancer, depression, and anxiety, without significant safety concerns reported. ^{1 3 6 7 8}

How is Meditation Therapy different from other treatments for cancer-related anxiety and depression?

Meditation Therapy, specifically Mindfulness-Based Stress Reduction (MBSR), is unique because it is a non-drug approach that uses mindfulness meditation to help reduce anxiety and depression in cancer patients. Unlike traditional treatments that may involve medication, MBSR focuses on stress management through structured meditation practices, which can improve emotional well-being without the side effects associated with drugs. ^{1 6 7 8 9}

Research Team

Gabriel Lopez

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

This trial is for cancer patients at MD Anderson who are currently in treatment or have finished it, can read and understand English, consent to participate, and can visit the Texas Medical Center. They should feel some anxiety or depression but not be severely affected (scores between 4-11 on ESAS). If they're taking anxiety meds, doses must be stable for six weeks with no changes expected soon.

Inclusion Criteria

Patients at MD Anderson with a cancer history who are either undergoing active treatment or who have completed treatment for their cancer

Must understand and read English, sign a written informed consent, and follow protocol requirements

Willing to come to MD Anderson Main Campus (Texas Medical Center) for enrollment

Exclusion Criteria

Known history of a neurological and/or psychological disorder that in the physician's opinion may interfere with the patient's ability to cooperate with study procedures

I have been diagnosed with a thought disorder like schizophrenia.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants in the meditation group watch a pre-recorded instructional meditation video and complete meditation exercises using an app for 5-15 minutes daily for up to 2 weeks. Participants in the waitlist control group receive supportive care for up to 2 weeks.

2 weeks

Daily self-administered sessions

Follow-up

Participants are monitored for changes in anxiety, depression, and other symptoms using questionnaires and interviews.

2 weeks

Treatment Details

Interventions

• Meditation Therapy

Trial Overview The study is testing if meditation therapy helps reduce anxiety and depression in cancer patients feeling psychosocial distress. It involves self-administered techniques like deep breathing to improve mental well-being and quality of life during or after cancer treatment.

Participant Groups

Group I: Group I (meditation) Experimental Treatment 3 Interventions

Patients watch a pre-recorded instructional meditation video via an iPod meditation app. Patients then complete meditation exercises using the meditation app over 5-15 minutes QD for up to 2 weeks. Patients also complete questionnaires before and after meditation sessions and participate in an interview over 10 minutes.

Group II: Group II (waitlist control) Active Control 3 Interventions

Patients receive supportive care, such as access to social workers, support groups, spiritual care, or other patient services for up to 2 weeks. Patients also complete questionnaires over 15-20 minutes and participate in an interview over 10 minutes.

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

Approved in United States as Mindfulness-Based Stress Reduction (MBSR) for:

• Anxiety
• Depression
• Stress
• Sleep Disturbances
• Quality of Life Improvement in Cancer Survivors

Approved in Canada as Mindfulness-Based Cancer Recovery (MBCR) for:

• Anxiety
• Depression
• Stress
• Fatigue
• Sleep Disturbances
• Quality of Life Improvement in Cancer Survivors

Approved in European Union as Mindfulness Meditation for:

• Anxiety
• Depression
• Stress
• Sleep Disturbances
• Quality of Life Improvement in Cancer Survivors

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Findings from Research

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) 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]

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) 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) 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]

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 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 therapy (MBT) significantly reduces symptoms of anxiety and depression in adult cancer patients and survivors, with moderate effect sizes observed in both nonrandomized studies (0.60 for anxiety, 0.42 for depression) and randomized controlled trials (0.37 for anxiety, 0.44 for depression).

The systematic review included 22 studies with a total of 1,403 participants, indicating that while the quality of studies varied, there is promising evidence from higher-quality randomized controlled trials supporting the efficacy of MBT in improving mental health outcomes for cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of mindfulness-based therapy on symptoms of anxiety and depression in adult cancer patients and survivors: a systematic review and meta-analysis. Piet, J., Würtzen, H., Zachariae, R.[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]

References

1. 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]

2. 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]

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. Switzerland pubmed.ncbi.nlm.nih.gov

Mindfulness-based stress reduction for breast cancer-a systematic review and meta-analysis. [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. India pubmed.ncbi.nlm.nih.gov

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

7. 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]

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

The effect of mindfulness-based therapy on symptoms of anxiety and depression in adult cancer patients and survivors: a systematic review and meta-analysis. [2022]

9. 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]