Prayer as a Possible Adjuvant Treatment for Breast Cancer - A Randomized Partially Blinded Controlled Clinical Trial Evaluating the Effect of Prayer on Humoral and Biochemical Parameters in Stage I-IV Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- A. Evaluate the effect of prayer on humoral (including biochemical/physiological inflammatory/immune) parameters approximately every three months at the subjects routine oncology visit.
研究概览
简要总结
The goal of this study is to help determine the biochemical mechanisms underlying previously demonstrated health benefits of prayer, and to track humoral changes in various prayer activities.
详细描述
The purpose of this pilot study is to investigate certain biological mechanisms that may underlie the beneficial effects seen among cancer patients who pray. It will evaluate the effect of prayer on humoral (including biochemical/physiological inflammatory/immune) parameters, monitor changes in cancer related biomarkers and evaluate the effect of prayer on blood pressure, quality of life, health and dietary habits in relation to prayer activities, using validated questionnaires.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 21 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Primary histological diagnosis of Stage I-IV breast cancer.
- •Initial diagnosis of breast cancer within 5 year of study enrollment.
- •Not currently receiving chemotherapy or radiation therapy. Hormone therapy is allowed.
- •Life expectancy of at least 12 months.
- •ECOG performance status of 0, 1, or
- •Willing to sign informed consent indicating that they are aware of the investigational nature of the study and the randomized study design.
- •Willing to comply with monthly follow-up phone calls.
- •Willing to complete questionnaires at regular oncology clinic visits.
- •Able to read write & understand English.
排除标准
- •Concurrent treatment with chemotherapy or radiation therapy
- •Less than 3 months since last dose of chemotherapy or radiation therapy.
- •Breast cancer diagnosis more than 5 years prior to study enrollment
- •Less than 21 or greater than to 80 years old.
- •Life threatening or severe concurrent non-malignant conditions.
- •Uncontrolled diabetes mellitus.
- •Severe heart disease.
- •Severe liver disease. Severe lung disease.
- •History of smoking within 5 years of study enrollment.
- •Psychological or psychiatric disorder that would interfere with study compliance.
- •History of missed appointments or poor medical compliance.
- •Inability to understand instructions on how to complete a questionnaire.
- •No access to a phone.
结局指标
主要结局
A. Evaluate the effect of prayer on humoral (including biochemical/physiological inflammatory/immune) parameters approximately every three months at the subjects routine oncology visit.
时间窗: 2 years
B. Monitor changes in cancer- related biomarkers, and evaluate these changes in relation to the participants' prayer activities as recorded since the previous oncology visit.
时间窗: 2 years
C. Evaluate the effect of prayer on blood pressure, quality of life, health and dietary habits in relation to prayer activities, using validated questionnaires.
时间窗: 2 years
次要结局
未报告次要终点