Developing an Integrative Ayurvedic Intervention for Breast Cancer Survivorship
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Change in quality of life over 12 months
研究概览
简要总结
The purpose of this study is to develop and test a 12-month Integrative Medicine intervention based on Ayurvedic medicine 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. The investigators aim to perform a prospective single arm clinical study of a manualized Ayurvedic approach in breast cancer survivors with impaired quality of life. Specifically, the investigators aim to refine 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 24 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 complete remission
- •Aged 18 years or older
- •Able to read, write, and understand English
- •Karnofsky Performance Status (KPS) greater than or equal to 60
- •Have impaired quality of life
- •Ability to give informed consent
排除标准
- •Having received Ayurvedic treatment within 6 months of study enrollment
- •Receiving chemotherapy or radiotherapy at the time of study enrollment. Anti-her2 directed 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 2 months
- •Have surgery for breast cancer or breast reconstructive surgery planned during the initial 6 month study period. Smaller surgical procedures such as implant exchange are not exclusionary.
研究组 & 干预措施
Integrative Medicine Intervention
Study participants will attend 14 visits with an integrative medicine clinician over the course of 6 months followed by a 6 month maintenance phase. The treatment modalities employed in the study will include nutrition and lifestyle recommendations.
干预措施: Individualized Integrative Medicine Intervention (Behavioral)
结局指标
主要结局
Change in quality of life over 12 months
时间窗: Baseline, 3 months, 6 months, 12 months
The investigators will use the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ C30) in conjunction with a Breast Cancer-Specific Subscale (BR23) to collect data on qualify of life and cancer-related symptoms.
次要结局
- Change in fatigue over 12 months(Baseline, 3 months, 6 months, 12 months)
- Change in depressive symptoms over 12 months(Baseline, 3 months, 6 months, 12 months)
- Change in sleep quality over 12 months(Baseline, 3 months, 6 months, 12 months)
- Change in anxiety over 12 months(Baseline, 3 months, 6 months, 12 months)
- Change in pain over 12 months(Baseline, 3 months, 6 months, 12 months)
- Change in diet over 12 months(Baseline, 3 months, 6 months, 12 months)