Evaluating the Effectiveness of Inquiry Based Stress Reduction (IBSR) Intervention Versus Regular Care of no Treatment on Well-being, Optimism and Health Behavior of BRCA1/2 Carriers: A Randomized Controlled Trial, RCT.
试验速览
- 阶段
- 3 期
- 入组人数
- 118
- 试验地点
- 2
- 主要终点
- The Ryff scale- Psychological well-being
研究概览
简要总结
Breast cancer (BC) is a major health problem and the most prevalent cancer among women.In a substantial proportion of familial cases, germ-line mutations in either BRCA1/2 can be detected. The only proven modality for active risk reduction (rather than passive early detection), is prophylactic surgery - prophylactic mastectomy and oophorectomy. While the majority of Jewish mutation carriers elect to undergo prophylactic oophorectomy at about age 40 years, in Israel only a minority perform prophylactic mastectomy. Another ramification of being a mutation carrier is the emotional stress associated with that discovery.Genetic information has profound implications for mutation carriers. The IBSR (Inquiry-based stress reduction) intervention, developed by Byron Katie, trains participants 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 provides skills for self-inquiry and management of stressful thoughts that can be easily implemented in daily life [ ]. Therefore, on the basis of previous data and beneficial observations we postulate that the clinical utility of IBSR mediation program may improve psychological and physical symptoms and quality of life among asymptomatic (oncologically healthy) BRCA1/ BRCA2 mutation carriers. Thus, we will conduct a pilot randomized controlled trial to scientifically investigate the effect of this intervention effects on BRCA1/2 mutation carriers.
详细描述
Primary goal: to evaluate the effectiveness of IBSR intervention on psychological well-being of BRCA carriers.
Secondary goals:
- To understand the IBSR action mechanism and to develop a theoretical model.
- To examine the correlation between psychological well-being and optimism and health behaviors among carriers.
- To evaluate and define core beliefs related to psychological well-being, optimism and expectations among carriers.
- To evaluate and define the health related behaviors among carriers.
Rationale for studies: The rationale of the research emerges from two aspects. One aspect is the effort to establish a new intervention program for women in order to help them deal with the daily implications of being a BRCA carrier. Up to date, only few interventions were carried out in Israel and worldwide, and had several methodological limitations.
The other aspect is the combination of quantitative and qualitative tools in order to analyze the psychological implications of a complicated medical state and to establish an intervention program in order to reduce their adverse impact. This combination can significantly contribute to the understanding of the investigated issue and the participants' experience. The current research is comprehensive and rigorous, and it is based on a randomized controlled study, which was carried out with 118 Israeli women.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women who are carriers of one of the predominant Jewish mutations in BRCA1/2 genes, age 25-55 years, with no current or past history of cancer (except BCC), who are willing to sign an informed consent, and present mental clarity by the ability to comprehend and fulfill all the questionnaires.
排除标准
- •Diagnosed with breast or ovarian cancer or any other cancer, risk reduction mastectomy, severe psychiatric diagnosis (e.g. bipolar disorder).
研究组 & 干预措施
Intervention
Inquiry Based Stress Reduction
干预措施: Inquiry Based Stress Reduction (IBSR) program (Behavioral)
Control
The placebo group participants will receive a modified form of the intervention at the close of the study
干预措施: Control (Behavioral)
结局指标
主要结局
The Ryff scale- Psychological well-being
时间窗: A measure assessing change between 3 time points (before the intervention, after 5 months (at the end of the intervention) and 3 months later)
Questionnaire
次要结局
- Life Orientation Test-Revise- LOT-R(A measure assessing change between 3 time points (before the intervention, after 5 months (at the end of the intervention) and 3 months later))
- Pittsburgh Sleep Quality Inventory Questionnaire- PSQI(A measure assessing change between 3 time points (before the intervention, after 5 months (at the end of the intervention) and 3 months later))
- Satisfaction with life scale - SWLS d(A measure assessing change between 3 time points (before the intervention, after 5 months (at the end of the intervention) and 3 months later))
- Positive and negative affect schedule PANAS(A measure assessing change between 3 time points (before the intervention, after 5 months (at the end of the intervention) and 3 months later))
- Self-assessed health SAH(A measure assessing change between 3 time points (before the intervention, after 5 months (at the end of the intervention) and 3 months later))
- Euroqol quality of life scale EQ-5D(A measure assessing change between 3 time points (before the intervention, after 5 months (at the end of the intervention) and 3 months later))
- Perceived social support from family PSS-FA(A measure assessing change between 3 time points (before the intervention, after 5 months (at the end of the intervention) and 3 months later))
- Mindfulness attention awareness scale MAAS(A measure assessing change between 3 time points (before the intervention, after 5 months (at the end of the intervention) and 3 months later))
- General self- efficacy GSE(A measure assessing change between 3 time points (before the intervention, after 5 months (at the end of the intervention) and 3 months later))
- Demographic and behavioral data(A measure assessing change between 3 time points (before the intervention, after 5 months (at the end of the intervention) and 3 months later))