Breast CancerPhase 3Med-RT BGNCT07166042
Guided Meditation During Radiation Therapy for Breast and Gynecological Malignancies
A Phase 3 study testing 10-15 minute, Audio-Recorded Guided Mediation Practices in people with Breast Cancer and Gynecologic Cancer, run by University of Utah at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Gynecologic Cancer
- What is being tested?
- 10-15 minute, Audio-Recorded Guided Mediation Practices
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Sep 2025to 30 Sep 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Huntsman Cancer Institute at University of Utah
Salt Lake City, Utah, 84112
Rachel Kingsford, 801-585-0115, rachel.kingsford@hci.utah.edu
About this study
Official title: Med-RT BG: An Interventional Trial Using Guided Meditation During Radiation Therapy for Breast and Gynecological Malignancies
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
- Being tested
- 10-15 minute, Audio-Recorded Guided Mediation Practices
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
10-15 minute, Audio-Recorded Guided Mediation PracticesBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Guided Meditation Intervention | Experimental | Not described Receives: Behavioral: 10-15 minute, Audio-Recorded Guided Mediation Practices |
| Standard of Care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in acute anxiety in participants receiving mindfulness intervention during RT compared to standard of care control conditions.
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.
Measured: 7 weeks
Secondary outcomes (3)
Change in anxiety in everyday life in participants receiving mindfulness intervention during RT compared to standard of care control conditions.
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.
Measured: 7 weeks
Change in anxiety during RT and in everyday life as measured by the modified MPoD
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".
Measured: 7 weeks
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).
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).
Measured: 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2025
- Study start25 Sep 2025
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lindsay Burt, MD, Principal investigator, Huntsman Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07166042
- Sponsor's protocol ID
- HCI192768
- Acronym
- Med-RT BG
- Status last verified
- Aug 2025
- First submitted
- 2 Sep 2025
- Last updated
- 3 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Med-RT BG: An Interventional Trial Using Guided Meditation During Radiation Therapy for Breast and Gynecological Malignancies
- ClinicalTrials.gov ID
- NCT07166042
- Acronym / sponsor ID
- Med-RT BG / HCI192768
- Conditions
- Breast Cancer, Gynecologic Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- 25 Sep 2025 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Sep 2028 (estimated)
- First posted
- 10 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Guided Meditation Intervention | Experimental | Behavioral: 10-15 minute, Audio-Recorded Guided Mediation Practices |
| Standard of Care | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 10-15 minute, Audio-Recorded Guided Mediation PracticesThe 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. | Behavioural | Guided Meditation Intervention |
Primary outcome
Change in acute anxiety in participants receiving mindfulness intervention during RT compared to standard of care control conditions.
Time frame: 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.
3 secondary outcomes
Change in anxiety in everyday life in participants receiving mindfulness intervention during RT compared to standard of care control conditions.
Time frame: 7 weeks
Change in anxiety during RT and in everyday life as measured by the modified MPoD
Time frame: 7 weeks
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).
Time frame: 7 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lindsay Burt, MD principal investigator
Huntsman Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 10-15 minute, Audio-Recorded Guided Mediation Practices in people with Breast Cancer and Gynecologic Cancer, run by University of Utah at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rachel R. Kingford (801-585-0115, rachel.kingsford@hci.utah.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2025.