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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how different meditation practices can help cancer survivors feel more relaxed and at peace. Participants will learn one of four meditation types: breathing only, focused attention only, mindfulness only, or a combination of all three. The researchers aim to determine which type best reduces stress and anxiety in individuals who have undergone cancer surgery. Long-term cancer survivors who have not engaged in extensive mind-body practice and experience anxiety might be a good fit for this study. As an unphased trial, this study offers a unique opportunity to explore personal well-being through meditation practices.

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.

Is there any evidence suggesting that this trial's meditation practices are likely to be safe for cancer survivors?

Research has shown that different types of meditation are generally safe and well-tolerated. Breathing meditation helps reduce stress and improve mindfulness in cancer patients. Mindfulness meditation can improve anxiety, stress, depression, and quality of life, indicating it is both safe and beneficial.

Combined meditation, which includes breathing, focused attention, and mindfulness, enhances relaxation and mental health. Studies have not reported major negative effects, indicating participants tolerate it well. Focused attention meditation reduces psychological distress and supports coping in cancer patients.

Overall, these meditation practices are considered safe and positively impact mental well-being, making them promising options for reducing stress and anxiety in cancer survivors. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these meditation therapies for cancer survivors because they offer a holistic approach to managing post-treatment stress and anxiety that differs from traditional options like medication or counseling. Unlike standard treatments, which often involve pharmaceuticals with potential side effects, these meditation techniques—breathing, mindfulness, focused attention, and their combination—emphasize self-care and mind-body connection. Each method provides a unique way for patients to engage their mental focus and relaxation skills, potentially leading to improved emotional well-being. Additionally, these therapies are non-invasive and empower patients to practice independently at home, offering a flexible and patient-centered solution to enhancing quality of life after cancer treatment.

What evidence suggests that this trial's meditation practices could be effective for relaxation in cancer survivors?

Research has shown that meditation can help cancer survivors relax and feel less stressed. In this trial, participants will try different meditation techniques. Breathing meditation, available in Arm I, can reduce tiredness in people with blood cancer. Mindfulness meditation, studied in Arm III, has significantly improved depression, anxiety, and stress in cancer survivors. Participants in Arm IV will experience combined meditation, which includes breathing, focused attention, and mindfulness, and has been linked to better mood and less anxiety and depression in cancer patients. Focused attention meditation, also offered in Arm I, can improve attention and mood in stressed cancer survivors. Overall, these meditation techniques have shown positive effects on the mental well-being of people who have experienced cancer. ^{2 6 7 8 9}

Who Is on the Research Team?

Richard T. Lee

Principal Investigator

City of Hope Medical Center

Are You a Good Fit for This Trial?

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

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

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

I am currently pregnant.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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) 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]

Citations

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