Trial of Inquiry Based Stress Reduction (IBSR) Program for BRCA1/2 Mutation Carriers
|Hereditary Breast and Ovarian Cancer Syndrome||Behavioral: Inquiry Based Stress Reduction (IBSR) program||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Pilot Randomized Controlled Trial of Inquiry Based Stress Reduction (IBSR) Program for BRCA1/2 Mutation Carriers|
- global psychology functioning(GSI) [ Time Frame: 12 Weeks ]
- Sleep quality (PSQI) [ Time Frame: 12 weeks ]
- Family support PSS-Fa [ Time Frame: 12 weeks ]
- cancer related worry (CRW) [ Time Frame: 12 weeks ]
|Study Start Date:||March 2011|
|Study Completion Date:||June 2012|
|Primary Completion Date:||December 2011 (Final data collection date for primary outcome measure)|
Inquiry Based Stress Reduction (IBSR) program
Behavioral: Inquiry Based Stress Reduction (IBSR) program
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01367639
|Sheba Medical Center|
|Tel-aviv, Israel, 52621|
|Principal Investigator:||Eitan Friedman, Prof.||Sheba Medical Center|
|Study Director:||Shahar Lev-ari, Dr.||Department of health promotion, faculty of medicine, Tel Aviv University|