Guided Meditation During Radiation Therapy for Breast and Gynecological Malignancies

Not Applicable

Not yet recruiting

• Conditions: Breast Cancer; Gynecologic Cancer

• Registration Number: NCT07166042
• Lead Sponsor: University of Utah

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-08
• Study First Submitted: 2025-09-02
• Study First Submitted QC: 2025-09-02
• Last Update Submitted: 2025-09-09
• Study First Posted: 2025-09-10
• Last Update Posted: 2025-09-16
• Study Start: 2025-09-30
• Primary Completion: 2027-09-30
• Study Completion: 2028-09-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 34

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in acute anxiety in participants receiving mindfulness intervention during RT compared to standard of care control conditions.	7 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Change in anxiety in everyday life in participants receiving mindfulness intervention during RT compared to standard of care control conditions.	7 weeks	To assess the distal anxiolytic effects of a brief mindfulness intervention during RT for patients with anxiety related to RT for breast and gynecological cancers.; Anxiety in everyday life will be measured using the total score of the Generalized Anxiety Disorder 2-item (GAD-2) scale prior to RT (minimum value 0, maximum value 6, score of 3 or higher considered clinical). This will be measured once a week during RT.
Change in anxiety during RT and in everyday life as measured by the modified MPoD	7 weeks	To determine whether the brief mindfulness intervention during RT increases patients' state mindfulness and whether the degree of changes in state mindfulness during RT predict decreases in acute anxiety and anxiety in daily life.; Modified Metacognitive Processes of Decentering Scale (MPoD) consists of 4 items scored on a 0-10 scale, "0" meaning "Not at All" and "10" meaning "Very Much".
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	To determine whether the brief mindfulness intervention during RT increases patients' self transcendence and whether the degree of changes in self-transcendence during RT predict decreases in anxiety in daily life. The NADA will ask patients to rate their feelings 15 minutes before and after treatment on a scale of 0 (not at all) to 10 (very much).

Trial Locations

Locations (1)

Huntsman Cancer Institute at University of Utah; 🇺🇸 Salt Lake City, Utah, United States