Prostate Cancer Clinical Trial
Official title:
Using Meditation to Treat Anxiety and Improve Quality of Life in Prostate Cancer Patients Receiving Radiation Therapy
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.
Status | Not yet recruiting |
Enrollment | 46 |
Est. completion date | February 1, 2025 |
Est. primary completion date | December 31, 2024 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Mellar Davis MD | Geisinger Clinic |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | General Anxiety Disorder-7 scale (GAD-7) | Validated tool to assess anxiety | Change from Baseline GAD-7 at Week 6 | |
Primary | Functional Assessment of Cancer Therapy-Prostate, Version 4 (FACT-P) | Validated measure of QOL in prostate cancer patients | Change from Baseline FACT-P at Week 6 | |
Secondary | Meditation Log | A blank log will be provided for the subjects to record the date and duration of the meditation sessions along with whether the meditation took place on a radiation treatment day and if the subject thought the meditation was helpful. | From Session 1 through Session 6 (6 weeks) | |
Secondary | Telephone Follow-up | 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. | four weeks following study completion |
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