Clinical trial · Interventional
Using Meditation for Oncology Anxiety
Using Meditation to Treat Anxiety and Improve Quality of Life in Prostate Cancer Patients Receiving Radiation Therapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Study was not started and PI is retiring.
Summary
Brief summary (as posted)
The current study is a prospective, interventional, randomized, treatment-controlled study, evaluating the use of Meditation with a Mantra (MM) to decrease anxiety levels and improve Quality of Life (QOL) in prostate cancer patients receiving radiation treatment. The study will be conducted across 6 radiation treatment sessions in men with newly diagnosed prostate cancer, Stage 1 to 3A, and men with recurrent prostate cancer. Patients will receive six radiation sessions with usual care with or without the addition of MM. MM Group patients will be given a log at the beginning of the study to record how long they are meditating and if they found meditation beneficial. The General Anxiety Disorder-7 scale (GAD-7) is a validated tool and will be used to assess anxiety in all participants. The Functional Assessment of Cancer Therapy-Prostate, Version 4 (FACT-P) is a validated measure of QOL in prostate cancer patients and will be used to assess QOL in all participants. A one month follow up phone call will determine if the patients are continuing to use the MM and if they found the practice of MM useful not only in their radiation treatment sessions but in their everyday lives.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anxiety | — | UNRESOLVED | — |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
| Prostate Cancer Recurrent | — | UNRESOLVED | — |
| Quality of Life | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Mantra Meditation | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Control Group
- description
- The Control Group participants (Group A) will be initiating radiation therapy and receiving only standard of care therapy per their Radiation Oncologist.
- type
- EXPERIMENTAL
- label
- Test Group
- description
- The Test Group participants (Group B) will be initiating radiation therapy and receiving standard of care therapy per their Radiation Oncologist. This group will also be taught mantra-based meditation to use during each radiation treatment session and encouraged to practice MM ad libitum outside of the treatment setting.
- interventionNames
- Other: Mantra Meditation
Primary outcomes (2)
- measure
- General Anxiety Disorder-7 scale (GAD-7)
- timeFrame
- Change from Baseline GAD-7 at Week 6
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Males age 18 years and older, at the time of signing the informed consent. 2. Diagnosis of prostate cancer, newly diagnosed or recurrent, scheduled to receive radiation therapy for a minimum of 6 treatments. 3. Participant is willing and able to comply with all protocol requirements and procedures. 4. Capable of giving signed informed consent. Exclusion Criteria: 1. Current treatment for anxiety with benzodiazepines. 2. Current treatment for generalized anxiety disorder with an Selective Serotonin Reuptake Inhibitor(SSRI) or Serotonin and Norepinephrine Reuptake Inhibitors (SNRI) initiated less than 6 weeks prior to enrollment in the study. Stable therapy for greater than 6 weeks prior to enrollment will be allowed. 3. Current use of meditation treatment or therapy. 4. Significant medical conditions which are likely to result in hospitalization during the study. 5. Any conditions which may interfere with the ability to receive and follow meditation instruction or answer questionnaires. 6. Impaired due to use of drugs or alcohol.
References
Publications (0)
Data not yet available