Clinical trial · Interventional
Guided Meditation During Radiation Therapy for Breast and Gynecological Malignancies
Med-RT BG: An Interventional Trial Using Guided Meditation During Radiation Therapy for Breast and Gynecological Malignancies
NCT07166042CI-TRIAL-00096279Med-RT BGrecruitingPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Gynecologic Cancer | Malignant Female Reproductive System Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 10-15 minute, Audio-Recorded Guided Mediation Practices | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Guided Meditation Intervention
- interventionNames
- Behavioral: 10-15 minute, Audio-Recorded Guided Mediation Practices
- type
- NO_INTERVENTION
- label
- Standard of Care
Primary outcomes (1)
- measure
- Change in acute anxiety in participants receiving mindfulness intervention during RT compared to standard of care control conditions.
- timeFrame
- 7 weeks
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.