Pilot Randomized Controlled Trial of Inquiry Based Stress Reduction (IBSR) Program for BRCA1/2 Mutation Carriers
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.
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
global psychology functioning(GSI)
Eitan Friedman, Prof.
Sheba Medical Center
Israel: Ministry of Health