Recruiting
Phase 3

Mindfulness & RT

Sponsor:

University of Utah

Code:

NCT07166042

Conditions

Breast Cancer

Gynecologic Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

10-15 minute, Audio-Recorded Guided Mediation Practices

Study Details

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 ID

NCT07166042

Start date

Sep 25, 2025

Status verified date

Aug, 2025

Completion date

Sep 30, 2028

Anticipated

Primary completion date

Sep 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

34 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Guided Meditation Intervention

no intervention: Standard of Care

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.

Primary outcome measure

  • Change in acute anxiety in participants receiving mindfulness intervention during RT compared to standard of care control conditions. [ Time Frame: 7 weeks ]

Central Contacts and Locations

Central contacts

Rachel R. Kingford

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

Locations

Huntsman Cancer Institute at University of Utah

Recruiting

Salt Lake City, Utah, United States, 84112

Contacts

Rachel Kingsford

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

More Information

Sponsor

University of Utah

Last update posted

Oct 3, 2025

Last verified

Aug, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Utah on 2025-10-03.