Guided Meditation During Radiation Therapy for Breast and Gynecological Malignancies

Purpose

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.

Conditions

  • Breast Cancer
  • Gynecologic Cancer

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Guided Meditation Intervention
  • 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.
No Intervention
Standard of Care

Recruiting Locations

Huntsman Cancer Institute at University of Utah
Salt Lake City, Utah 84112
Contact:
Rachel Kingsford
801-585-0115
rachel.kingsford@hci.utah.edu

More Details

NCT ID
NCT07166042
Status
Recruiting
Sponsor
University of Utah

Study Contact

Rachel R. Kingford
801-585-0115
rachel.kingsford@hci.utah.edu

For help using this page: trialstoday@researchmatch.org or call 855-514-7001

ResearchMatch is funded in part by the National Institutes of Health (NIH) Clinical and Translational Science Award (CTSA) program, led by the NIH’s National Center for Advancing Translational Sciences (NCATS), grants UL1TR000445 and 1U54RR032646-01, and grant U24TR001579 from NCATS and the National Library of Medicine. The content of this website is solely the responsibility of ResearchMatch and Vanderbilt University and does not necessarily represent the official views of the NIH, NCATS, or NLM.

Vanderbilt University Medical Center