NCT07166042 · University of Utah
Guided Meditation During Radiation Therapy for Breast and Gynecological Malignancies
(Med-RT BG)
What this study is about
The goal of this study is to assess the effect of brief mindfulness-guided meditations during radiation therapy (RT) for patients with anxiety related to RT for breast and gynecological cancers.
View original scientific description
The goal of this study is to assess the effect of brief mindfulness-guided meditations during radiation therapy (RT) for patients with anxiety related to RT for breast and gynecological cancers.
Interventions
BEHAVIORAL
10-15 minute, Audio-Recorded Guided Mediation Practices
The 5 mindfulness practices, all of which have been validated in prior research. Body Scan practice will consist of how to direct non-judgmental attention to different regions of the body The Mindful Breathing practice will consist of focused attention on the breath and metacognitive monitoring and acceptance of discursive thoughts, negative emotions, and body sensations. The Mindfulness of Discomfort practice will consist of instruction in how to "zoom in" to deconstruct discomfort and precisely map each feelings' spatial location, use mindful breathing to "zoom out" and broaden the field of awareness to include neglected sensory elements, and shift attention from unpleasant feelings to neutral/pleasant sensations or experiences. The Savoring practice will consist of instruction in identifying and amplifying pleasant memories. The Loving-Kindness practice will consist of instruction in cultivating feeling of warmth and compassion toward the self and others.
Primary outcome measures
Change in acute anxiety in participants receiving mindfulness intervention during RT compared to standard of care control conditions.
Time frame: 7 weeks
To assess the acute anxiolytic effects of a brief mindfulness intervention during radiation therapy (RT) for patients with anxiety related to RT for breast and gynecological cancers. Acute anxiety during RT will be measured at each treatment visit with an individual item ("How nervous, anxious or on edge do you feel right now?" scored on a 0 (not at all) to 10 (Very much). derived from the Generalized Anxiety Disorder 2-item (GAD-2) scale, measured before and after RT. The change from before to after RT will be averaged over all treatment visits.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Participant aged ≥ 18 years.
- Diagnosis of breast or gynelogical cancer.
- Eligible to receive 15-25 daily radiation therapy treatments for breast or gynelogical cancer.
- Willing to participate in either the guided meditation or standard of care control arm, regardless of treatment assignment.
- Karnofsky performance score ≥ 60 or ECOG performance score ≤ 2.
- Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines.
Exclusion criteria
- Active suicidal ideation or active psychotic state in the opinion of the investigator.
- Patient is receiving deep inspiration breath hold treatment.
- An unstable illness that, in the opinion of the investigator, would interfere with study treatment.
- Prior radiation therapy.
- Inability to understand and/or speak the English language.
Where
- Salt Lake City, Utah
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 3, 2025 · Source of record for eligibility and locations