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

Hereditary Breast and Ovarian Cancer Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01367639
• Other study ID #: SHEBA-10-8400-EF-CTIL
• Status: Completed
• Phase: Phase 2
• First received: May 31, 2011
• Last updated: November 22, 2013
• Start date: March 2011
• Est. completion date: June 2012

Study information

• Verified date: November 2013
• Source: Sheba Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: June 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 35 Years to 70 Years

Eligibility

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).

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hereditary Breast and Ovarian Cancer Syndrome

Intervention

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

Locations

Country	Name	City	State
Israel	Sheba Medical Center	Tel-aviv

Sponsors (1)

Lead Sponsor	Collaborator
Sheba Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	global psychology functioning(GSI)		12 Weeks	No
Primary	Sleep quality (PSQI)		12 weeks	No
Secondary	Family support PSS-Fa		12 weeks	No
Secondary	cancer related worry (CRW)		12 weeks	No