Recruiting NCT07166042
Guided Meditation During Radiation Therapy for Breast and Gynecological Malignancies
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 10-15 minute, Audio-Recorded Guided Mediation Practices.
- Who it may be relevant to
- Registry conditions: Breast Cancer, Gynecologic Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Med-RT BG: An Interventional Trial Using Guided Meditation During Radiation Therapy for Breast and Gynecological Malignancies
Overview
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 preci
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]
Secondary outcome measures (3)
- Change in anxiety in everyday life in participants receiving mindfulness intervention during RT compared to standard of care control conditions. [Time frame: 7 weeks]
- Change in anxiety during RT and in everyday life as measured by the modified MPoD [Time frame: 7 weeks]
- 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]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Huntsman Cancer Institute at University of Utah — Salt Lake City
Identifiers
NCT: NCT07166042 · HCI192768