Pilot Clinical Trial (Phase II) of Inquiry-based Stress Reduction (IBSR) Program for Survivors of Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
研究概览
简要总结
The IBSR (Inquiry-based stress reduction) intervention, developed by Byron Katie (www.thework.com), trains subjects to reduce their perceived level of stress by self-inquiry of their thoughts and beliefs connected to stressful circumstances or symptoms. This meditative process, named "The Work", enables the participants to identify and question the stressful thoughts that cause their suffering. The core of IBSR is simply four questions and a turnaround, which is a way of experiencing the opposite of what the participant believes. This process is simple, powerful and can be easily implemented in daily life.
Therefore, on the basis of previous data and beneficial observations the investigators postulate that the clinical utility of IBSR mediation program may improve psychological and physical symptoms and quality of life among BC patients during the survivorship period. Thus, we will conduct a pilot/feasibility randomized controlled clinical trial designed to
- Assess feasibility of a IBSR intervention by examining attendance, drop-out rates, and program satisfaction.
- Determine whether IBSR intervention compared with usual care is efficacious in improving quality of life, psychological and physical status in BC survivors.
详细描述
Study methodology:
The proposed study is pilot/feasibility intervention study with pre and post measures. 30 participants will receive Inquiry-based stress reduction (IBSR) group intervention.
Population:
Women aged 21 or older previously diagnosed with Stage 0-III BC who underwent surgery and received adjuvant or neo-adjuvant chemotherapy and/or radiation will be recruited from the Tel Aviv Medical Center Oncology Department affiliated to Tel-Aviv university.
Inclusion Criteria:
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 90 Years(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Bx proven breast cancer
- •Known disease stage
- •Subjects completed treatment within the prior 18 months
- •Subjects are able to read and speak Hebrew at the ninth grade level or higher, as will be judged by their ability to complete a battery of self-report measures
- •Willing to sign an informed consent
排除标准
- •Stage IV BC
- •Prophylactic mastectomy prior to the current treatment for BC
- •Severe psychiatric diagnosis (e.g. bipolar disorder)
- •Treatment for recurrent BC
