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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how meditation therapy, a mind-body approach using techniques like deep breathing and sound, can reduce anxiety and depression in cancer patients. Participants will either use a meditation app daily for two weeks or receive supportive care, such as access to support groups. The trial aims to determine if meditation can improve mental health and quality of life for those experiencing cancer-related distress. It is suitable for English-speaking cancer patients at MD Anderson who are experiencing anxiety or depression and can attend sessions at the Texas Medical Center. As an unphased trial, it offers a unique opportunity for patients to explore innovative therapies that could enhance their mental well-being.

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 prior data suggests that meditation therapy is safe for cancer patients with anxiety and depression?

Research has shown that meditation therapy is generally safe for most people. Studies have found that mindfulness and meditation can help reduce anxiety and depression, especially in cancer patients. Meditation therapy includes activities like deep breathing and gentle movement, which are non-invasive and carry very low risk. Most people tolerate these practices well, with few negative effects reported. Overall, meditation therapy is considered a safe way to enhance mental well-being in cancer patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about meditation therapy for cancer-related anxiety and depression because it offers a non-drug alternative that can be easily integrated into daily life. Unlike typical treatments involving medications or extensive psychotherapy sessions, this approach uses short, guided meditation exercises accessed through an app, making it highly accessible and convenient. Meditation therapy aims to reduce anxiety and depression symptoms by promoting relaxation and mindfulness, potentially offering quicker emotional relief without the side effects associated with medications.

What evidence suggests that meditation therapy might be an effective treatment for cancer-related anxiety and depression?

Research has shown that mindfulness practices can reduce anxiety and depression in cancer patients. Studies have found that these practices improve quality of life by lowering stress and emotional distress related to cancer. Mindfulness techniques, such as meditation, have effectively eased symptoms like depression and anxiety. This trial will evaluate meditation therapy, with one group of participants engaging in meditation exercises using a meditation app. These findings suggest that meditation therapy could be a helpful tool for managing emotional distress in cancer patients. ^{2 3 6 7 8}

Who Is on the Research Team?

Gabriel Lopez

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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 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]

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]

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