Guided Meditation for Brain Tumors

(Med-RT Trial)

Overseen By Rachel Kingsford

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Utah

Disqualifiers: Suicidal ideation, Psychotic state, 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

30 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this interventional treatment study is to assess the anxiolytic effect of providing guided meditation during radiation treatment (RT) in patients with brain tumors. The main question it aims to answer is: • What is the change in acute anxiety in participants receiving the mindfulness intervention during radiation therapy compared to standard of care control conditions? Participants will be asked to participate in a 5-minute, audio-recorded mindfulness practice that will be played during the administration of each RT session. Researchers will compare this intervention to standard of care (no intervention) during RT.

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 seems focused on meditation during radiation therapy, so it's likely you can continue your usual medications, but you should confirm with the study team.

What data supports the effectiveness of the treatment Guided Meditation, Mindfulness Meditation, Relaxation Therapy for brain tumors?

Research shows that mindfulness meditation can improve sleep quality and reduce anxiety and depression in cancer patients, which suggests it might help brain tumor patients manage stress and improve their overall well-being. ^{1 2 3 4 5}

Is guided meditation safe for humans?

Guided meditation, including mindfulness-based stress reduction, is generally considered safe for humans, but there are some concerns about potential adverse events (unwanted effects). A systematic review has investigated these events, suggesting that while meditation is widely used, it is important to be aware of any negative effects that might occur. ^{1 4 5 6 7}

How does guided meditation differ from other treatments for brain tumors?

Guided meditation for brain tumors is unique because it focuses on improving mental well-being and reducing stress, rather than directly targeting the tumor itself. Unlike traditional medical treatments, it uses mindfulness techniques to help patients manage symptoms and improve quality of life, which is particularly important as there are no standard treatments for the psychological challenges faced by brain tumor patients. ^{8 9 10 11 12}

Research Team

Lindsay M. Burt

Principal Investigator

Huntsman Cancer Institute/ University of Utah

Eligibility Criteria

This trial is for adults over 18 with brain tumors who are set to undergo 25-33 radiation treatments. They must have a certain level of physical and cognitive ability, be willing to try guided meditation or just standard care, and able to consent. People with suicidal thoughts, psychosis, unstable illnesses that could affect treatment, previous brain radiation therapy, or those not fluent in English can't join.

Inclusion Criteria

I am open to being assigned to either meditation or standard care in the study.

I am approved for 25-33 radiation treatments for my brain tumor.

I have a brain tumor confirmed by imaging tests.

Exclusion Criteria

An unstable illness that, in the opinion of the investigator, would interfere with study treatment

I have had radiation therapy to my brain.

Active suicidal ideation or active psychotic state in the opinion of the investigator

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation Therapy

Participants receive radiation therapy with guided meditation to assess anxiolytic effects

7 weeks

Weekly visits for radiation therapy

Follow-up

Participants are monitored for changes in anxiety and self-transcendence after radiation therapy

4 weeks

Treatment Details

Interventions

• Guided Meditation

Trial Overview The study tests if a short guided meditation played during each radiation session can reduce anxiety more than the usual care without any intervention. Participants will either receive this mindfulness practice or follow the standard procedure as they go through their scheduled treatments.

Participant Groups

Group I: Guided Meditation Intervention Experimental Treatment 1 Intervention

Group II: Standard of Care Active Control 1 Intervention

Who Is Running the Clinical Trial?

University of Utah

Lead Sponsor

Trials

1,169

Recruited

1,623,000+

Findings from Research

Mindfulness-based stress reduction significantly improved subjective sleep parameters in patients with insomnia related to cervical cancer, showing benefits like reduced total wake time and increased total sleep time after an 8-week program.

However, while subjective improvements were noted, objective sleep measurements (polysomnography data) did not show significant changes, indicating that the benefits may not translate to measurable sleep quality improvements over the long term.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized controlled trial of mindfulness-based stress reduction for insomnia secondary to cervical cancer: Sleep effects. Zhang, H., Li, Y., Li, M., et al.[2020]

Mindfulness-based stress reduction (MBSR) shows promising psychological benefits for cancer patients, as indicated by various instruments measuring its impact, although the effectiveness of these instruments varies.

The review highlights the need for more rigorous intervention studies on MBSR in cancer care to better understand its benefits and to refine the tools used to measure its effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Measuring the psychological impact of mindfulness meditation on health among patients with cancer: a literature review. Matchim, Y., Armer, JM.[2007]

Both meditation techniques—meditation with a coach and self-meditation with a CD—were effective in reducing anxiety, depression, and emotional distress in patients undergoing radiation therapy for head and neck cancer, as shown in a study of 28 patients over 12 weeks.

Self-meditation with a CD was found to be a more cost-effective option compared to meditation with a coach, making it a practical choice for patients facing high stress during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of Two Types of Meditation on Patients' Psychosocial Responses During Radiation Therapy for Head and Neck Cancer. Boxleitner, G., Jolie, S., Shaffer, D., et al.[2017]

An 8-week Mindfulness-Based Stress Reduction (MBSR) program significantly improved sleep quality in 63 cancer patients, with overall sleep disturbance reduced (p < .001).

Participants also experienced significant reductions in stress, mood disturbance, and fatigue, suggesting that MBSR can enhance the overall quality of life for cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of mindfulness-based stress reduction (MBSR) on sleep, mood, stress and fatigue symptoms in cancer outpatients. Carlson, LE., Garland, SN.[2018]

An 8-week mindfulness treatment delivered through an app was feasible for some patients with brain tumors, with 20 participants starting the study, but only 10 completed it, highlighting challenges in recruitment and retention.

Participants who completed the program reported significant improvements in mindfulness and illness-related quality of life, although there was a decline in social/family quality of life, indicating the need for further research to optimize engagement and outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of a novel application of a mindfulness phone application for patients with brain tumours: a feasibility study. De Tommasi, C., Richardson, E., Reale, M., 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]

A systematic review of 83 studies involving 6703 participants found that 8.3% experienced adverse events (AEs) related to meditation, with higher prevalence in observational studies (33.2%) compared to experimental studies (3.7%).

The most common adverse events included anxiety (33%), depression (27%), and cognitive anomalies (25%), indicating that meditation can lead to negative effects, even in individuals without prior mental health issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events in meditation practices and meditation-based therapies: a systematic review. Farias, M., Maraldi, E., Wallenkampf, KC., et al.[2021]

Goal Management Training (GMT) significantly improved executive functions and real-life functioning in 25 brain tumor survivors, with benefits maintained at a 4-month follow-up.

Participants in the GMT group reported fewer cognitive concerns and achieved greater functional goal attainment compared to those in the active control and wait-list groups, suggesting that GMT is a promising intervention for cognitive dysfunction in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive rehabilitation for executive dysfunction in brain tumor patients: a pilot randomized controlled trial. Richard, NM., Bernstein, LJ., Mason, WP., et al.[2020]

A couple-based meditation (CBM) program delivered via FaceTime was found to be feasible and acceptable for couples dealing with brain tumors, with 63% of participants completing all assessments.

Patients in the CBM group showed significant improvements in cognitive symptoms, general disease symptoms, relationship well-being, and compassion, indicating that the intervention may effectively enhance their quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Online Couple-Based Meditation Intervention for Patients With Primary or Metastatic Brain Tumors and Their Partners: Results of a Pilot Randomized Controlled Trial. Milbury, K., Weathers, SP., Durrani, S., et al.[2023]

A virtual reality relaxation intervention was found to be feasible and acceptable for patients with primary brain tumors, with 50% enrollment from those approached and high satisfaction reported by 90% of participants.

The intervention had a low incidence of mild adverse effects (7 cases), indicating it is a safe option for managing distress and anxiety during neuroimaging procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of a virtual reality intervention targeting distress and anxiety symptoms in patients with primary brain tumors: Interim analysis of a phase 2 clinical trial. King, AL., Roche, KN., Leeper, HE., et al.[2023]

This phase 2 clinical trial involves 120 primary brain tumor patients using a remote virtual reality (VR) relaxation intervention to help reduce distress and anxiety, particularly around MRI scans and clinical evaluations.

The study aims to establish the feasibility of this VR intervention and assess its preliminary effectiveness in improving psychological symptoms, potentially paving the way for larger trials and similar interventions for other cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and preliminary efficacy of a virtual reality intervention targeting distress and anxiety in primary brain tumor patients at the time of clinical evaluation: Study protocol for a phase 2 clinical trial. King, AL., Acquaye, AA., Mendoza, T., et al.[2023]

A phase 2 clinical trial involving 120 primary brain tumor patients aims to assess the feasibility of a remote virtual reality (VR) relaxation intervention to help reduce distress and anxiety, particularly during the stressful period before MRI scans.

The study will evaluate the preliminary efficacy of the VR intervention in improving psychological symptoms, with follow-up assessments conducted immediately after the intervention and at 1 and 4 weeks, potentially paving the way for larger trials in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and preliminary efficacy of a virtual reality intervention targeting distress and anxiety in primary brain tumor patients at the time of clinical evaluation: Study protocol for a phase 2 clinical trial. King, AL., Acquaye-Mallory, AA., Vera, E., et al.[2023]

References

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

A randomized controlled trial of mindfulness-based stress reduction for insomnia secondary to cervical cancer: Sleep effects. [2020]

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

Measuring the psychological impact of mindfulness meditation on health among patients with cancer: a literature review. [2007]

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

Comparison of Two Types of Meditation on Patients' Psychosocial Responses During Radiation Therapy for Head and Neck Cancer. [2017]

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

Impact of mindfulness-based stress reduction (MBSR) on sleep, mood, stress and fatigue symptoms in cancer outpatients. [2018]

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

Evaluation of a novel application of a mindfulness phone application for patients with brain tumours: a feasibility study. [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

Adverse events in meditation practices and meditation-based therapies: a systematic review. [2021]

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

Cognitive rehabilitation for executive dysfunction in brain tumor patients: a pilot randomized controlled trial. [2020]

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

Online Couple-Based Meditation Intervention for Patients With Primary or Metastatic Brain Tumors and Their Partners: Results of a Pilot Randomized Controlled Trial. [2023]

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

Feasibility of a virtual reality intervention targeting distress and anxiety symptoms in patients with primary brain tumors: Interim analysis of a phase 2 clinical trial. [2023]

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

Feasibility and preliminary efficacy of a virtual reality intervention targeting distress and anxiety in primary brain tumor patients at the time of clinical evaluation: Study protocol for a phase 2 clinical trial. [2023]

12. England pubmed.ncbi.nlm.nih.gov

Feasibility and preliminary efficacy of a virtual reality intervention targeting distress and anxiety in primary brain tumor patients at the time of clinical evaluation: Study protocol for a phase 2 clinical trial. [2023]