Using Meditation to Treat Anxiety and Improve Quality of Life in Prostate Cancer Patients Receiving Radiation Therapy
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 入组人数
- 46
- 主要终点
- General Anxiety Disorder-7 scale (GAD-7)
研究概览
简要总结
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.
详细描述
The current study is a prospective, interventional, randomized, treatment-controlled study, evaluating the use of 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. Approximately forty-six patients will be recruited to allow for forty patients to complete assessments. Twenty-three patients will receive six radiation sessions with MM and will be the Test Group. Twenty-three will receive usual care without MM and will be the Control Group. The Test Group will be taught how to meditate using a standard one-word mantra (Om). The first MM session would be a 30-minute introductory session prior to the first radiation treatment followed by five 20-minute sessions prior to each of the remaining five radiation treatments. The Control Group will receive radiation treatments without MM. During the five 20-minute sessions, the patients will receive a meditation refresher and reinforcement to continue to practice meditation at home. The teaching of MM during all sessions will be done by a dedicated research assistant with a Master of Science in Yoga Therapy. Test 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. The GAD-7 and FACT-P will be assessed at baseline, radiation Session 3 and radiation Session 6 to determine the impact of MM on anxiety and QOL, respectively, in the Test Group compared to the Control Group. 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Males age 18 years and older, at the time of signing the informed consent.
- •Diagnosis of prostate cancer, newly diagnosed or recurrent, scheduled to receive radiation therapy for a minimum of 6 treatments.
- •Participant is willing and able to comply with all protocol requirements and procedures.
- •Capable of giving signed informed consent.
排除标准
- •Current treatment for anxiety with benzodiazepines.
- •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.
- •Current use of meditation treatment or therapy.
- •Significant medical conditions which are likely to result in hospitalization during the study.
- •Any conditions which may interfere with the ability to receive and follow meditation instruction or answer questionnaires.
- •Impaired due to use of drugs or alcohol.
结局指标
主要结局
General Anxiety Disorder-7 scale (GAD-7)
时间窗: Change from Baseline GAD-7 at Week 6
Validated tool to assess anxiety
Functional Assessment of Cancer Therapy-Prostate, Version 4 (FACT-P)
时间窗: Change from Baseline FACT-P at Week 6
Validated measure of QOL in prostate cancer patients
次要结局
- Meditation Log(From Session 1 through Session 6 (6 weeks))
- Telephone Follow-up(four weeks following study completion)
研究者
Mellar Davis MD
Staff Physician Palliative Care
Geisinger Clinic