NCT07166042 Guided Meditation During Radiation Therapy for Breast and Gynecological Malignancies
| NCT ID | NCT07166042 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | University of Utah |
| Condition | Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 34 participants |
| Start Date | 2025-09-25 |
| Primary Completion | 2027-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 34 participants in total. It began in 2025-09-25 with a primary completion date of 2027-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Lindsay Burt, MD
PRINCIPAL INVESTIGATOR
Huntsman Cancer Institute/ University of Utah
Frequently Asked Questions
Who can join the NCT07166042 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07166042 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 34 participants.
Is NCT07166042 currently recruiting?
Yes, NCT07166042 is actively recruiting participants. Contact the research team at rachel.kingsford@hci.utah.edu for enrollment information.
Where is the NCT07166042 trial being conducted?
This trial is being conducted at Salt Lake City, United States.
Who is sponsoring the NCT07166042 clinical trial?
NCT07166042 is sponsored by University of Utah. The principal investigator is Lindsay Burt, MD at Huntsman Cancer Institute/ University of Utah. The trial plans to enroll 34 participants.
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