Self-Administered Meditation Intervention for Cancer Patients With Psychosocial Distress
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Feasibility of self-administered meditation
研究概览
简要总结
This trial studies how well self-administered meditation therapy works in improving anxiety and depression in cancer patients who exhibit psychosocial distress. Meditation therapy is a mind-body approach that uses a variety of techniques, such as deep breathing, sound, or movement, that may help to decrease distress and anxiety and enhance the health and quality of life of patients with cancer.
详细描述
PRIMARY OBJECTIVES:
I. To determine the feasibility of having patients self-administer meditation recordings using a portable, computer-based program during a 2-week period.
SECONDARY OBJECTIVES:
I. Assess the effect of self-administered meditation on anxiety, depression and other symptoms that are part of the Edmonton Symptom Assessment Scale (ESAS) questionnaire.
II. Evaluate participant satisfaction with the meditation delivery and tracking program.
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
- All
- 接受健康志愿者
- 否
入选标准
- •Patients at MD Anderson with a cancer history who are either undergoing active treatment or who have completed treatment for their cancer
- •Must understand and read English, sign a written informed consent, and follow protocol requirements
- •Willing to come to MD Anderson Main Campus (Texas Medical Center) for enrollment
- •Patient self-reported ESAS psychological scale score (sum of anxiety and depression scores) between 4 and 11 (and/or) individual anxiety or depression score between 4 and 7 on a 0 to 10 numeric scale, where 10 is the worst possible
- •If on medication for anxiety, stable dose of medications for management of anxiety symptoms for at least six weeks prior to enrollment with no plans to change meditations in the subsequent four weeks. Increases or decreases allowed within drug class, but changing drug class will make patient in-evaluable
排除标准
- •Diagnosis of a formal thought disorder (e.g., schizophrenia)
- •Known history of a neurological and/or psychological disorder that in the physician's opinion may interfere with the patient's ability to cooperate with study procedures
研究组 & 干预措施
Group I (meditation)
Patients watch a pre-recorded instructional meditation video via an iPod meditation app. Patients then complete meditation exercises using the meditation app over 5-15 minutes QD for up to 2 weeks. Patients also complete questionnaires before and after meditation sessions and participate in an interview over 10 minutes.
干预措施: Interview (Other)
Group I (meditation)
Patients watch a pre-recorded instructional meditation video via an iPod meditation app. Patients then complete meditation exercises using the meditation app over 5-15 minutes QD for up to 2 weeks. Patients also complete questionnaires before and after meditation sessions and participate in an interview over 10 minutes.
干预措施: Meditation Therapy (Procedure)
Group I (meditation)
Patients watch a pre-recorded instructional meditation video via an iPod meditation app. Patients then complete meditation exercises using the meditation app over 5-15 minutes QD for up to 2 weeks. Patients also complete questionnaires before and after meditation sessions and participate in an interview over 10 minutes.
干预措施: Quality-of-Life Assessment (Procedure)
Group II (waitlist control)
Patients receive supportive care, such as access to social workers, support groups, spiritual care, or other patient services for up to 2 weeks. Patients also complete questionnaires over 15-20 minutes and participate in an interview over 10 minutes.
干预措施: Interview (Other)
Group II (waitlist control)
Patients receive supportive care, such as access to social workers, support groups, spiritual care, or other patient services for up to 2 weeks. Patients also complete questionnaires over 15-20 minutes and participate in an interview over 10 minutes.
干预措施: Quality-of-Life Assessment (Procedure)
Group II (waitlist control)
Patients receive supportive care, such as access to social workers, support groups, spiritual care, or other patient services for up to 2 weeks. Patients also complete questionnaires over 15-20 minutes and participate in an interview over 10 minutes.
干预措施: Supportive Care (Procedure)
结局指标
主要结局
Feasibility of self-administered meditation
时间窗: Up to 2 weeks
Feasibility will be confirmed if at least 50% of the eligible patients approached consent to the study and at least 70% of subjects complete at least two meditation sessions each week during the 2-week period. The study will calculate rates, frequencies, and 90% confidence intervals (CIs) of the rates.
次要结局
- Self-administered meditation effect on anxiety and depression as measured by the Edmonton Symptom Assessment Scale (ESAS) questionnaire(Up to 2 weeks)
- Frequency of meditation and choice of length of meditation(Up to 2 weeks)
- The study will evaluate participant satisfaction with the meditation delivery and tracking program using appropriate descriptive statistics.(Up to 2 weeks)