RECRUITINGPhase 3INTERVENTIONAL

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

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.

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.

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)

Huntsman Cancer Institute at University of Utah

Salt Lake City, Utah, United States