A Whole Systems Approach to the Study of Ayurveda for Cancer Survivorship, Project II
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Change in quality of life over 16 weeks
研究概览
简要总结
The purpose of this study is to determine whether a four-month manualized Ayurvedic intervention will improve quality of life in recent breast cancer survivors.
详细描述
Cancer associated symptoms and impaired quality of life remain significant problems for patients despite advances in cancer treatment. Few effective treatment options exist for these symptoms. Integrative medicine is rising in popularity in the United States; however, few integrative medicine modalities have been rigorously studied. Ayurveda, a whole system of medicine that originated in the Indian subcontinent, has its own system of diagnostics and therapeutics, and among its strengths are wellness and prevention. We aim to perform a prospective single arm clinical study of a manualized Ayurvedic approach in breast cancer survivors with impaired quality of life. Specifically, we aim to develop the manualized Ayurvedic intervention; to assess feasibility; and to determine whether clinically meaningful effects can be achieved with the intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- Female
- 接受健康志愿者
- 否
入选标准
- •Female breast cancer survivor who is over 1 month and less than 12 months beyond the completion of primary therapy (surgery, radiation, and chemotherapy)
- •Having received chemotherapy as part of their primary therapy for breast cancer
- •Be in a complete remission
- •Aged 18 years or older
- •Able to read, write, and understand English
- •Karnofsky Performance Status (KPS) 67 greater than
- •Ability to give informed consent
排除标准
- •Having received Ayurvedic treatment within 2 months of study enrollment
- •Receiving chemotherapy or radiotherapy at the time of study enrollment. Trastuzumab therapy is not exclusionary.
- •Being within 1 month (before or after) of surgery for breast cancer (including breast reconstructive surgery). Smaller surgical procedures such as implant exchange are not exclusionary.
- •Patients on adjuvant hormone therapy for less than 1 month
结局指标
主要结局
Change in quality of life over 16 weeks
时间窗: Baseline, End of week 8, End of week 16
The investigators will use the EORTC QLQ C30 (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire) 68 in conjunction with a breast cancer-specific subscale, BR23, to collect data on quality of life and cancer-related symptoms.
次要结局
未报告次要终点