Guided Meditation for Brain Tumors
(Med-RT Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Utah
Disqualifiers: Suicidal ideation, Psychotic state, others
No Placebo Group
Approved in 3 Jurisdictions
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.
12345Is 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.
14567How 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.
89101112Eligibility 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 18 years old or older.
I am approved for 25-33 radiation treatments for my brain tumor.
+4 more
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
+1 more
Trial 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
Participant Groups
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.
2Treatment groups
Experimental Treatment
Active Control
Group I: Guided Meditation InterventionExperimental Treatment1 Intervention
Group II: Standard of CareActive Control1 Intervention
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Huntsman Cancer InstituteSalt Lake City, UT
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Who Is Running the Clinical Trial?
University of UtahLead Sponsor
References
A randomized controlled trial of mindfulness-based stress reduction for insomnia secondary to cervical cancer: Sleep effects. [2020]To evaluate the efficacy of mindfulness-based stress reduction on objective and subjective sleep parameters and hypnotic medication use of patients with insomnia secondary to cervical cancer.
Measuring the psychological impact of mindfulness meditation on health among patients with cancer: a literature review. [2007]To describe the construct of mindfulness meditation and systematically review instruments measuring the psychological impact of mindfulness-based stress reduction (MBSR) on health among patients with cancer.
Comparison of Two Types of Meditation on Patients' Psychosocial Responses During Radiation Therapy for Head and Neck Cancer. [2017]Radiation treatment for head and neck cancer introduces adaptive demands and subjects patients to significant and unique psychosocial challenges. There is growing evidence that meditation is useful in lessening anxiety and depression in cancer patients. This study compared the effects of two types of meditation training on the psychological responses of patients with head and neck cancer during radiation therapy.
Impact of mindfulness-based stress reduction (MBSR) on sleep, mood, stress and fatigue symptoms in cancer outpatients. [2018]Sleep disturbance is a very common problem for cancer patients that has largely not been addressed in the clinical intervention literature. Mindfulness meditation has demonstrated clinical benefits for a variety of patient populations in other areas of functioning. This study examined the effects of an 8-week Mindfulness-Based Stress Reduction (MBSR) program on the sleep quality of a heterogeneous sample of 63 cancer patients. Overall sleep disturbance was significantly reduced (p
Evaluation of a novel application of a mindfulness phone application for patients with brain tumours: a feasibility study. [2021]Despite the large clinical interest in mindfulness, little is known about its effects in patients with brain tumours. Novel delivery methods such as App based Mindfulness training (AMT) may assist in the delivery of mindfulness treatment to this group of patients.
Audio recordings of mindfulness-based stress reduction training to improve cancer patients' mood and quality of life--a pilot feasibility study. [2022]Mindfulness-based stress reduction (MBSR), typically taught in eight weekly classes, helps patients cope with illness, including cancer. Current research is almost exclusively based on post-treatment class attendance. Research suggests that short courses and alternative delivery techniques may also be beneficial. This pilot study assessed whether it would be feasible for cancer patients receiving chemotherapy to listen to MBSR audio recordings individually during treatment and at home and evaluate whether the intervention shows preliminary evidence of efficacy to improve patients' mood and quality of life (QoL).
Adverse events in meditation practices and meditation-based therapies: a systematic review. [2021]Meditation techniques are widely used as therapy and wellbeing practices, but there are growing concerns about its potential for harm. The aim of the present study is to systematically review meditation adverse events (MAEs), investigating its major clinical categories and its prevalence.
Cognitive rehabilitation for executive dysfunction in brain tumor patients: a pilot randomized controlled trial. [2020]Patients with brain tumors face unique quality of life challenges. Executive dysfunction is common and functionally limiting, with no established treatments as standard care. This pilot study evaluated the efficacy of Goal Management Training (GMT), a behavioral intervention combining mindfulness and strategy training, for improving executive and real-life functioning in this population.
Online Couple-Based Meditation Intervention for Patients With Primary or Metastatic Brain Tumors and Their Partners: Results of a Pilot Randomized Controlled Trial. [2023]Although patients with primary and metastatic brain tumors and their partners are at risk of experiencing high symptom burden, they are often excluded from psychosocial intervention studies. Thus, we sought to examine the feasibility and preliminary efficacy of a couple-based meditation (CBM) program targeting symptom and well-being outcomes.
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]Purpose: Cancer patients experience distress and anxiety when undergoing imaging studies to monitor disease status, yet these symptoms are not always appropriately identified or well-managed. This interim analysis of a phase 2 clinical trial explored feasibility and acceptability of a virtual reality relaxation (VR) intervention for primary brain tumor (PBT) patients at the time of clinical evaluation. Methods: English speaking, adult PBT patients with previous reports of distress and upcoming neuroimaging were recruited between March of 2021 and March 2022. A brief VR session was done within 2 weeks prior to neuroimaging with patient-reported outcomes (PROs) collected before and immediately post-intervention. Self-directed VR use over the next 1 month was encouraged with additional PROs assessments at 1 and 4 weeks. Feasibility metrics included enrollment, eligibility, attrition, and device-related adverse effects with satisfaction measured with qualitative phone interviews. Results: 55 patients were approached via email, 40 (73%) responded and 20 (50%) enrolled (9 declines, 11 screen fails). 65% of participants were ≤ 50 years, 50% were male, 90% were White/non-Hispanic, 85% had good KPS (≥ 90), and most were on active treatment. All patients completed the VR intervention, PROs questionnaires, weekly check-ins, and qualitative interview. Most (90%) reported frequent VR use and high satisfaction and only 7 mild AEs were recorded (headache, dizziness, nausea, neck pain). Conclusion: This interim analysis confirmed feasibility and acceptability of a novel VR intervention to target psychological symptoms for PBT patients. Trial enrollment will continue to assess for intervention efficacy. Trial Registration: NCT04301089 registered on 3/9/2020.
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]Background: Primary brain tumor (PBT) patients experience higher levels of distress and anxiety than other solid tumor patients, particularly at the time of clinical evaluation when uncertainty about disease status is high ("scanxiety"). There is promising evidence supporting use of virtual reality (VR) to target psychological symptoms in other solid tumor patients, though PBT patients have not been studied extensively in this context. The primary aim of this phase 2 clinical trial is to establish the feasibility of a remote VR-based relaxation intervention for a PBT population, with secondary aims designed to determine preliminary efficacy of improving distress and anxiety symptoms. Methods: PBT patients (N=120) with upcoming MRI scans and clinical appointments who meet eligibility will be recruited to participate in a single arm trial conducted remotely through the NIH. Following completion of baseline assessments, participants will complete a 5-minute VR intervention via telehealth using a head-mounted immersive device while under supervision of the research team. Following the intervention, over the course of 1 month patients can use VR at their discretion with follow-up assessments done immediately post-VR intervention, as well as 1 week and 4 weeks later. Additionally, a qualitative phone interview will be conducted to assess patient satisfaction with the intervention. Discussion: Use of immersive VR is an innovative interventional approach to target distress and scanxiety symptoms in PBT patients who are at high risk for experiencing these symptoms leading into their clinical appointments. Findings from this study may inform design of a future multicenter randomized VR trial for PBT patients and may aid in development of similar interventions for other oncology populations. Trial Registration: clinicaltrials.gov (NCT04301089), registered 9 March 2020.
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]Primary brain tumor (PBT) patients experience higher levels of distress and anxiety than other solid tumor patients, particularly at the time of clinical evaluation when uncertainty about disease status is high ("scanxiety"). There is promising evidence supporting use of virtual reality (VR) to target psychological symptoms in other solid tumor patients, though PBT patients have not been studied extensively in this context. The primary aim of this phase 2 clinical trial is to establish the feasibility of a remote VR-based relaxation intervention for a PBT population, with secondary aims designed to determine preliminary efficacy of improving distress and anxiety symptoms.