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

Study Overview
=================
Brief 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
-----------------
Primary goal: to evaluate the effectiveness of IBSR intervention on psychological well-being of BRCA carriers. Secondary goals: To understand the IBSR action mechanism and to develop a theoretical model. To examine the correlation between psychological well-being and optimism and health behaviors among carriers. To evaluate and define core beliefs related to psychological well-being, optimism and expectations among carriers. To evaluate and define the health related behaviors among carriers. Rationale for studies: The rationale of the research emerges from two aspects. One aspect is the effort to establish a new intervention program for women in order to help them deal with the daily implications of being a BRCA carrier. Up to date, only few interventions were carried out in Israel and worldwide, and had several methodological limitations. The other aspect is the combination of quantitative and qualitative tools in order to analyze the psychological implications of a complicated medical state and to establish an intervention program in order to reduce their adverse impact. This combination can significantly contribute to the understanding of the investigated issue and the participants' experience. The current research is comprehensive and rigorous, and it is based on a randomized controlled study, which was carried out with 118 Israeli women. Research plan and milestones: Research Design: A randomized controlled study offering IBSR intervention for BRCA carriers. Research sample: 118 asymptomatic BRCA1/2 carriers, being followed-up in the high-risk clinic at Sheba hospital and meet the inclusion criteria: asymptomatic carriers of BRCA1/2 mutation, level of Hebrew, age group and psychiatric illness. Age: 25-55 Intervention group: 59 carriers who will participate in a 8-12 sessions (up to 48 hours) group workshop of IBSR. Control group: 59 carriers who will not participate in the workshop. They will complete questionnaires on the same time points as the intervention group. Participants who completed all the questionnaires will receive an IBSR kit for home practice. Research outcomes: psychological well-being, optimism, satisfaction with life, mental well-being, quality of sleep health behaviors and perceptions. In addition, the main themes from the qualitative interviews.

Official Title
-----------------
Evaluating the Effectiveness of Inquiry Based Stress Reduction (IBSR) Intervention Versus Regular Care of no Treatment on Well-being, Optimism and Health Behavior of BRCA1/2 Carriers: A Randomized Controlled Trial, RCT.

Conditions
-----------------
Hereditary Breast and Ovarian Cancer Syndrome

Intervention / Treatment
-----------------
* Behavioral: Inquiry Based Stress Reduction (IBSR) program
* Behavioral: Control


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women who are carriers of one of the predominant Jewish mutations in BRCA1/2 genes, age 25-55 years, 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, risk reduction mastectomy, severe psychiatric diagnosis (e.g. bipolar disorder).

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 55 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Inquiry Based Stress Reduction | Behavioral: Inquiry Based Stress Reduction (IBSR) program<br>* 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<br>|
| Placebo Comparator: Control<br>The placebo group participants will receive a modified form of the intervention at the close of the study | Behavioral: Control<br>* At end of intervention, the control group will receive a brief intervention consisting of a home kit for practicing IBSR techniques.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Ryff scale- Psychological well-being | Questionnaire | A measure assessing change between 3 time points (before the intervention, after 5 months (at the end of the intervention) and 3 months later) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Life Orientation Test-Revise- LOT-R | This questionnaire assesses the degree of optimism | A measure assessing change between 3 time points (before the intervention, after 5 months (at the end of the intervention) and 3 months later) | 
| Satisfaction with life scale - SWLS d | This questionnaire assesses the degree of Satisfaction with the life | A measure assessing change between 3 time points (before the intervention, after 5 months (at the end of the intervention) and 3 months later) | 
| Pittsburgh Sleep Quality Inventory Questionnaire- PSQI | This questionnaire assesses the quality of sleep | A measure assessing change between 3 time points (before the intervention, after 5 months (at the end of the intervention) and 3 months later) | 
| Positive and negative affect schedule PANAS | This questionnaire assesses the degree of positive and negative feelings | A measure assessing change between 3 time points (before the intervention, after 5 months (at the end of the intervention) and 3 months later) | 
| Self-assessed health SAH | This questionnaire assesses the personal perceived health | A measure assessing change between 3 time points (before the intervention, after 5 months (at the end of the intervention) and 3 months later) | 
| Euroqol quality of life scale EQ-5D | This questionnaire assesses the quality of life | A measure assessing change between 3 time points (before the intervention, after 5 months (at the end of the intervention) and 3 months later) | 
| Perceived social support from family PSS-FA | This questionnaire assesses the perceived family support | A measure assessing change between 3 time points (before the intervention, after 5 months (at the end of the intervention) and 3 months later) | 
| Mindfulness attention awareness scale MAAS | This questionnaire assesses the degree of mindfulness attention | A measure assessing change between 3 time points (before the intervention, after 5 months (at the end of the intervention) and 3 months later) | 
| General self- efficacy GSE | This questionnaire assesses the degree of self- efficacy | A measure assessing change between 3 time points (before the intervention, after 5 months (at the end of the intervention) and 3 months later) | 
| Demographic and behavioral data | This questionnaire asks about demographics data and health behavior | A measure assessing change between 3 time points (before the intervention, after 5 months (at the end of the intervention) and 3 months later) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
BRCA 1/2 Carriers, The Work, RCT, IBSR