Trial of Inquiry Based Stress Reduction (IBSR) Program for BRCA1/2 Mutation Carriers
Condition: Hereditary Breast and Ovarian Cancer Syndrome
MeSH terms: Hereditary Breast and Ovarian Cancer Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      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.
    

Detailed description: 
      Main Goals: To investigate whether IBSR intervention is efficacious in improving quality of
      life, psychological and physical status in BRCA1/2 mutation carriers.

      Secondary-goal: To Assess feasibility of IBSR intervention by examining attendance, drop-out
      rates, and program satisfaction.

      Hypothesis Participants' ability to deal with emotional difficulties will be improved
      following participation in the IBSR intervention. This will be reflected in improving the
      values of psychological measures, such as quality of sleep, cancer related worry, family
      support, depression and anxiety, after the intervention (among participants in the
      intervention group, but not in the control group).

      Study population: Eligible individuals are women who are carriers of one of the predominant
      Jewish mutations in BRCA1/2 genes at the Meirav Center, Sheba Medical center over the past 10
      years. All eligible women will be contacted by the staff of the Meirav Center and will be
      offered participation during routine follow up visits at the high risk clinic, by phone or a
      letter. Interested individuals will be scheduled to attend a meeting at a time of their
      convenience with the PI or the Co PIs to explain the study aims and goals. After the
      participant has agreed and signed the informed consent she is considered eligible.
    

Intervention name(s): Inquiry Based Stress Reduction (IBSR) program
Intervention type(s): Behavioral
Intervention description(s): 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
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: BRCA 1/2 Carriers; IBSR; The Work; Randomized clinical trial