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NCT Number: NCT07166042

Guided Meditation During Radiation Therapy for Breast and Gynecological Malignancies

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Gynecologic Cancer Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Huntsman Cancer Institute at University of Utah

Salt Lake City, Utah, 84112, United States

Location status: Recruiting

Location contact

Rachel Kingsford

CONTACT

[email protected]

801-585-0115

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

10-15 minute, Audio-Recorded Guided Mediation Practices

Behavioral

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 outcomes

  1. 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.

Secondary outcomes

  1. Change in anxiety in everyday life in participants receiving mindfulness intervention during RT compared to standard of care control conditions.

    Time frame: 7 weeks

    To assess the distal anxiolytic effects of a brief mindfulness intervention during RT for patients with anxiety related to RT for breast and gynecological cancers.

    Anxiety in everyday life will be measured using the total score of the Generalized Anxiety Disorder 2-item (GAD-2) scale prior to RT (minimum value 0, maximum value 6, score of 3 or higher considered clinical). This will be measured once a week during RT.

  2. Change in anxiety during RT and in everyday life as measured by the modified MPoD

    Time frame: 7 weeks

    To determine whether the brief mindfulness intervention during RT increases patients' state mindfulness and whether the degree of changes in state mindfulness during RT predict decreases in acute anxiety and anxiety in daily life.

    Modified Metacognitive Processes of Decentering Scale (MPoD) consists of 4 items scored on a 0-10 scale, "0" meaning "Not at All" and "10" meaning "Very Much".

  3. Change in self transcendence and the magnitude/degree of increased self transcendence will predict degree of anxiety in the course of daily life as measured by total score of the Nondual Awareness Dimensional Assessment (NADA).

    Time frame: 7 weeks

    To determine whether the brief mindfulness intervention during RT increases patients' self transcendence and whether the degree of changes in self-transcendence during RT predict decreases in anxiety in daily life. The NADA will ask patients to rate their feelings 15 minutes before and after treatment on a scale of 0 (not at all) to 10 (very much).

Study contacts

Contact information is provided by the study sponsor or research team.

Rachel R. Kingford

CONTACT

[email protected]

801-585-0115

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Registry information

Official study title

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

Acronym: Med-RT BG

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Sep 10, 2025
Registry last updated
Oct 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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