Guided Meditation During Radiation Therapy for Breast and Gynecological Malignancies

Med-RT BG: An Interventional Trial Using Guided Meditation During Radiation Therapy for Breast and Gynecological Malignancies

Guided Meditation During Radiation Therapy for Breast and Gynecological Malignancies (NCT07166042) is a Phase 3 interventional studying Breast Cancer and Gynecologic Cancer, sponsored by University of Utah. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

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.

What Stage of Research Is This?

Phase 3 trials confirm efficacy and safety in large patient groups (often 300–3,000+) and form the evidence base for an FDA approval submission. For Breast Cancer, Phase 3 studies typically randomize participants between the investigational treatment and either a placebo or current standard of care. A successful Phase 3 result is the threshold most treatments need to clear before regulatory approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 34 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 willing to sign a consent form and willing to sign an approved consent form that conforms to federal and institutional guidelines. Who Should NOT Join This Trial: - 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. Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

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.

Treatments Being Tested

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.

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Huntsman Cancer Institute at University of Utah

Salt Lake City, Utah, United States

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07166042), the sponsor (University of Utah), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07166042 clinical trial studying?

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. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT07166042?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07166042?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT07166042. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07166042. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.