Developing an Integrative Intervention for Breast Cancer Survivorship
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Change in quality of life over 6 months
研究概览
简要总结
The purpose of this study is to conduct a randomized controlled trial or RCT of the following 2 supportive care interventions in recent breast cancer survivors: an Integrative Medicine intervention based on Ayurvedic medicine and a Health Education intervention.
详细描述
Post-treatment cancer survivorship is often associated with a void in care given the drop-off in support provided to survivors from the medical team as well as family and friends. In addition, 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. In the Integrative Medicine intervention, Ayurvedic nutrition and lifestyle guidance will be presented, along with instruction in Yoga. In the Health Education intervention, informative content on issues relevant to breast cancer survivors will be presented including the physical, social and emotional impacts of survivorship. The investigators aim to perform a pilot RCT in breast cancer survivors with impaired quality of life. Specifically, the investigators aim to assess feasibility of randomization, adherence and retention to the Integrative Medicine and Health Education interventions.
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
- 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.
结局指标
主要结局
Change in quality of life over 6 months
时间窗: Baseline, 3 months, 6 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. The scales range in score from 0 to 100. A high scale score represents a higher response level. Thus a high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems. The principle for scoring these scales is the same in all cases: 1. Estimate the average of the items that contribute to the scale; this is the raw score. 2. Use a linear transformation to standardise the raw score, so that scores range from 0 to 100; a higher score represents a higher ("better") level of functioning, or a higher ("worse") level of symptoms.
次要结局
- Change in depressive symptoms over 6 months(Baseline, 3 months, 6 months)
- Change in diet over 6 months(Baseline, 3 months, 6 months)
- Change in sleep quality over 6 months(Baseline, 3 months, 6 months)
- Change in anxiety over 6 months(Baseline, 3 months, 6 months)
- Change in fatigue over 6 months(Baseline, 3 months, 6 months)
- Change in pain over 6 months(Baseline, 3 months, 6 months)