Guided Meditation During Radiation Therapy for Breast and Gynecological Malignancies

NCT ID: NCT07166042

Last Updated: 2025-10-03

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-25
• Study Completion Date: 2028-09-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Guided Meditation Intervention

Group Type: EXPERIMENTAL

10-15 minute, Audio-Recorded Guided Mediation Practices

Intervention Type: 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.

Standard of Care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Utah

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lindsay Burt, MD

Role: PRINCIPAL_INVESTIGATOR

Huntsman Cancer Institute/ University of Utah

Locations

Huntsman Cancer Institute at University of Utah

Salt Lake City, Utah, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Rachel R. Kingford

Role: CONTACT

rachel.kingsford@hci.utah.edu

801-585-0115

Facility Contacts

Rachel Kingsford

Role: primary

rachel.kingsford@hci.utah.edu

801-585-0115

Other Identifiers

HCI192768

Identifier Type: -

Identifier Source: org_study_id