Meditation for Cancer Survivors

Recruiting at 1 trial location

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: City of Hope Medical Center

Disqualifiers: Active cancer, Psychiatric disorders, Pregnancy, 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: 3

Duration: 6 weeks

44 Participants Needed

Trial Summary

What is the purpose of this trial?

This clinical trial compares the impact of four types of meditation practices, breathing only, focused attention only, mindfulness only, and breathing, focused attention and mindfulness combined, for relaxation in cancer survivors. Studies show that many patients with cancer experience stress and anxiety. Meditation therapy uses a variety of techniques, such as breathing, sound, or movement, that may help to decrease distress and anxiety and enhance the health and quality of life of patients with cancer. The trial is being done to find out how meditation can help cancer survivors feel relaxed and attain a peaceful state of mind.

Do I need to stop taking my current medications for the trial?

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 Therapy, Mindfulness-Based Stress Reduction (MBSR), Mindfulness-Based Cancer Recovery (MBCR), Mindfulness Meditation for cancer survivors?

Research shows that mindfulness-based stress reduction (MBSR) can help improve psychological distress and quality of life in breast cancer survivors, suggesting it may be beneficial for cancer survivors in general. ^{1 2 3 4 5}

Is meditation safe for cancer survivors?

Research on mindfulness-based stress reduction (MBSR) for breast cancer survivors suggests it is generally safe and can help reduce stress and anxiety, improve mood, and enhance quality of life. ^{1 2 4 6 7}

How does the treatment Meditation Therapy differ from other treatments for cancer survivors?

Meditation Therapy, specifically Mindfulness-Based Stress Reduction (MBSR), is unique because it focuses on reducing stress and increasing present-moment awareness through attentional and meditative exercises, which can improve psychological well-being and quality of life for cancer survivors. Unlike traditional medical treatments, MBSR is a complementary health approach that can be practiced online and has shown potential benefits in reducing symptoms like depression, anxiety, and insomnia, especially with consistent daily practice. ^{2 3 4 7 8}

Research Team

Richard T. Lee

Principal Investigator

City of Hope Medical Center

Eligibility Criteria

This trial is for cancer survivors who are looking to reduce stress and anxiety through meditation. Participants will try one of four meditation practices to see which helps them relax the most.

Inclusion Criteria

Visual Analog Scale (VAS) anxiety score of > 3 from a range from 0 to 10

I haven't practiced mind-body relaxation for more than 3 hours or regularly in the last year.

Documented written informed consent of the participant

Exclusion Criteria

Ongoing active psychiatric condition, depressive/bi-polar related disorders, anxiety, psychosis disorders, or substance use that may interfere with the study

I have not had serious illnesses like strokes or heart disease affecting my brain.

My cancer is currently active.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants learn one of four meditation practices with an instructor over 60 minutes for 3 sessions within 6 weeks, practice at home, and undergo saliva sample collection

6 weeks

3 visits (in-person)

Follow-up

Participants are monitored for relaxation and adherence to meditation practices

4 weeks

Treatment Details

Interventions

• Meditation Therapy

Trial Overview The study tests four types of meditation: breathing, focused attention, mindfulness, and a combination of all three. The goal is to determine which method best promotes relaxation and improves quality of life in cancer survivors.

Participant Groups

Group I: Arm IV (combined meditation) Experimental Treatment 3 Interventions

Patients learn breathing, focused attention, and mindfulness combined meditation with an instructor over 60 minutes for 3 sessions within 6 weeks. Patients also practice meditation at home and undergo saliva sample collection on study.

Group II: Arm III (mindfulness only meditation) Experimental Treatment 3 Interventions

Patients learn mindfulness only meditation with an instructor over 60 minutes for 3 sessions within 6 weeks. Patients also practice meditation at home and undergo saliva sample collection on study.

Group III: Arm I (focused attention only meditation) Experimental Treatment 3 Interventions

Patients learn focused attention only meditation with an instructor over 60 minutes for 3 sessions within 6 weeks. Patients also practice meditation at home and undergo saliva sample collection on study.

Group IV: Arm I (breathing only meditation) Experimental Treatment 3 Interventions

Patients learn breathing only meditation with an instructor over 60 minutes for 3 sessions within 6 weeks. Patients also practice meditation at home and undergo saliva sample collection on study.

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?

City of Hope Medical Center

Lead Sponsor

Trials

614

Recruited

1,924,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Findings from Research

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]

The study investigates the effectiveness of mindfulness-based stress reduction (MBSR) as a complementary health approach for breast cancer survivors, focusing on its potential to reduce stress and enhance present-moment awareness.

The research aims to assess whether there is sufficient evidence and consistent methodologies to support the use of MBSR specifically for this population, highlighting the need for standardized outcomes in future studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness as an Intervention for Breast Cancer Survivors. Kiely, D., Schwartz, S.[2017]

The modified mindfulness-based stress reduction (MBSR) program for breast cancer patients showed promising effects on reducing psychological distress and improving quality of life, with significant improvements noted in distress, general wellbeing, and fatigue-related quality of life after 8 weeks.

Although the study did not meet its feasibility goals for enrollment and retention, 66.7% of participants completed at least 7 out of 8 sessions, indicating potential interest and benefit in mindfulness interventions for cancer recovery in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prospective feasibility study of a mindfulness-based program for breast cancer patients in the southeastern US. Salvador, C., Mark, P., Hoenemeyer, T., 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 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]

A pilot study involving 23 cancer patients undergoing chemotherapy showed that listening to mindfulness-based stress reduction (MBSR) audio recordings improved mood and quality of life, with anxiety and depression scores decreasing significantly from an average of 18.3 to 12.2 over 3 months.

The study demonstrated that this individual audio intervention is feasible, as 87% of participants completed the protocol, suggesting that further research with larger clinical trials is warranted to confirm these benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Audio recordings of mindfulness-based stress reduction training to improve cancer patients' mood and quality of life--a pilot feasibility study. Altschuler, A., Rosenbaum, E., Gordon, P., et al.[2022]

In a study of 82 post-treatment breast cancer survivors, a 6-week mindfulness-based stress reduction program (MBSR(BC)) significantly reduced fear of recurrence and improved physical functioning compared to usual care.

These improvements in fear of recurrence and physical functioning were linked to reductions in perceived stress and anxiety, highlighting the cognitive mechanisms through which MBSR(BC) exerts its beneficial effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness based stress reduction (MBSR(BC)) in breast cancer: evaluating fear of recurrence (FOR) as a mediator of psychological and physical symptoms in a randomized control trial (RCT). Lengacher, CA., Shelton, MM., Reich, RR., et al.[2021]

An 8-week internet-based Mindfulness-based Stress Reduction (iMBSR) program significantly reduced symptoms of depression, anxiety, and insomnia in 48 breast cancer survivors compared to those who did not participate.

Participants who practiced mindfulness for more than 30 minutes daily experienced the greatest improvements, suggesting a dose-response relationship where increased practice time leads to better psychological outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Psychological Effect of Internet-Based Mindfulness-Based Stress Reduction on the Survivors of Breast Cancer During the COVID-19. Kang, C., Sun, S., Yang, Z., et al.[2021]

References

1. 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]

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

Mindfulness as an Intervention for Breast Cancer Survivors. [2017]

3. England pubmed.ncbi.nlm.nih.gov

Prospective feasibility study of a mindfulness-based program for breast cancer patients in the southeastern US. [2022]

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

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

5. Switzerland pubmed.ncbi.nlm.nih.gov

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

6. Germany pubmed.ncbi.nlm.nih.gov

Audio recordings of mindfulness-based stress reduction training to improve cancer patients' mood and quality of life--a pilot feasibility study. [2022]

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

Mindfulness based stress reduction (MBSR(BC)) in breast cancer: evaluating fear of recurrence (FOR) as a mediator of psychological and physical symptoms in a randomized control trial (RCT). [2021]

8. Switzerland pubmed.ncbi.nlm.nih.gov

The Psychological Effect of Internet-Based Mindfulness-Based Stress Reduction on the Survivors of Breast Cancer During the COVID-19. [2021]