Trial of Inquiry Based Stress Reduction (IBSR) Program for BRCA1/2 Mutation Carriers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT01367639
First received: May 31, 2011
Last updated: November 22, 2013
Last verified: November 2013

May 31, 2011
November 22, 2013
March 2011
December 2011   (final data collection date for primary outcome measure)
  • global psychology functioning(GSI) [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
  • Sleep quality (PSQI) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • anxiety and global psychology functioning(GSI) (BSI). [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
  • Sleep quality (PSQI) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01367639 on ClinicalTrials.gov Archive Site
  • Family support PSS-Fa [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • cancer related worry (CRW) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Trial of Inquiry Based Stress Reduction (IBSR) Program for BRCA1/2 Mutation Carriers
Pilot Randomized Controlled Trial of Inquiry Based Stress Reduction (IBSR) Program for BRCA1/2 Mutation Carriers

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.

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.

Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Hereditary Breast and Ovarian Cancer Syndrome
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
Experimental: intervention
Inquiry Based Stress Reduction (IBSR) program
Intervention: Behavioral: Inquiry Based Stress Reduction (IBSR) program
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
67
June 2012
December 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Women who are carriers of one of the predominant Jewish mutations in BRCA1/2 genes, age 35 years or older, 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.

Exclusion Criteria:

  • Diagnosed with breast or ovarian cancer or any other cancer, self reported Pregnancy, risk reduction mastectomy, severe psychiatric diagnosis (e.g. bipolar disorder).
Female
35 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Israel
 
NCT01367639
SHEBA-10-8400-EF-CTIL
No
Sheba Medical Center
Sheba Medical Center
Not Provided
Principal Investigator: Eitan Friedman, Prof. Sheba Medical Center
Study Director: Shahar Lev-ari, Dr. Department of health promotion, faculty of medicine, Tel Aviv University
Sheba Medical Center
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP