Guided meditation during radiation for breast and gynecologic cancers

Med-RT BG: An Interventional Trial Using Guided Meditation During Radiation Therapy for Breast and Gynecological Malignancies

This project will test whether short guided meditations played during daily radiation can reduce anxiety for adults receiving radiation for breast or gynecologic cancer.

Quick facts

• Phase: PHASE3
• Study type: Interventional
• Enrollment: 34 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of Utah (other)
• Drugs / interventions: radiation
• Locations: 1 site (Salt Lake City, Utah)
• Trial ID: NCT07166042 on ClinicalTrials.gov

What this trial studies

Adults with breast or gynecologic cancer who are scheduled for 15–25 daily radiation therapy sessions are enrolled and assigned to either a brief guided meditation or a standard-of-care control during their RT visits. The intervention consists of 10–15 minute audio-recorded mindfulness-guided meditations delivered at treatment sessions. Key eligibility includes age ≥18, adequate performance status (KPS ≥60 or ECOG ≤2), English proficiency, no prior radiation, and not receiving deep inspiration breath hold. The study measures patient-reported anxiety and related outcomes across the radiation course to see if in-session meditation reduces distress.

Who should consider this trial

Good fit: Ideal candidates are English-speaking adults (≥18 years) with breast or gynecologic cancer planning to receive 15–25 daily radiation therapy fractions, with KPS ≥60 or ECOG ≤2, who have not had prior radiation and are willing to be assigned to either intervention or control.

Not a fit: Patients with active suicidal ideation or psychosis, those receiving deep inspiration breath hold, non-English speakers, those with prior radiation, or people who do not experience RT-related anxiety are less likely to benefit from this intervention.

Why it matters

Potential benefit: If successful, patients may experience less anxiety and greater comfort during daily radiation, which could improve treatment tolerance and quality of life.

How similar studies have performed: Smaller trials and pilot studies of mindfulness and audio-guided interventions in oncology have reported reduced anxiety and distress, but few large phase 3 trials during radiation therapy have been completed.

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.

Where this trial is running

Salt Lake City, Utah

• Huntsman Cancer Institute at University of Utah — Salt Lake City, Utah, United States (RECRUITING)

Study contacts

• Principal investigator: Lindsay Burt, MD — Huntsman Cancer Institute/ University of Utah
• Study coordinator: Rachel R. Kingford

Conditions: Breast Cancer, Gynecologic Cancer