Guided Meditation During Radiation Therapy for Breast and Gynecological Malignancies

NCT07166042 | Recruiting Phase 3 DMC

• 1 other identifier: HCI192768
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

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

Outcome Measures

Primary Outcomes (1)

• Change in acute anxiety in participants receiving mindfulness intervention during RT compared to standard of care control conditions.

  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.

  7 weeks

Secondary Outcomes (3)

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

  7 weeks

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

  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).

  7 weeks

Study Arms (2)

Guided Meditation Intervention

EXPERIMENTAL

Behavioral: 10-15 minute, Audio-Recorded Guided Mediation Practices

Standard of Care

NO INTERVENTION

Interventions

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.

Guided Meditation Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

Huntsman Cancer Institute at University of Utah

Salt Lake City, Utah, 84112, United States

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Lindsay Burt, MD

  Huntsman Cancer Institute/ University of Utah

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rachel R. Kingford

CONTACT

801-585-0115; rachel.kingsford@hci.utah.edu

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2025
• First Posted: September 10, 2025
• Study Start: September 25, 2025
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): September 30, 2028
• Last Updated: October 3, 2025

Record last verified: 2025-08

Locations

US (1)