Guided Meditation During Radiation Therapy for Breast and Gynecological Malignancies (Med-RT BG)

Utah System of Higher Education (USHE)

Status and phase: Enrolling; Phase 3

Conditions: Breast Cancer; Gynecologic Cancer

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

Study type: Interventional

Funder types: Other

Identifiers

NCT07166042

HCI192768

Details and patient eligibility

About

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.

Enrollment: 34 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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34 participants in 2 patient groups

Guided Meditation Intervention

Experimental group

Treatment:

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

Standard of Care

No Intervention group