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

September 5, 2018 updated by: Sheba Medical Center

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.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
118

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Israel
      • Tel Hashomer, Israel
        • Recruiting
        • Eitan Friedman
        • Contact:
          • Eitan Friedman, Prof
      • Tel-aviv, Israel, 52621
        • Enrolling by invitation
        • Sheba Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

25 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intervention
Inquiry Based Stress Reduction
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
Placebo Comparator: Control
The placebo group participants will receive a modified form of the intervention at the close of the study
Behavioral: Control
At end of intervention, the control group will receive a brief intervention consisting of a home kit for practicing IBSR techniques.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The Ryff scale- Psychological well-being
Time Frame: A measure assessing change between 3 time points (before the intervention, after 5 months (at the end of the intervention) and 3 months later)
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Life Orientation Test-Revise- LOT-R
Time Frame: A measure assessing change between 3 time points (before the intervention, after 5 months (at the end of the intervention) and 3 months later)
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
Time Frame: A measure assessing change between 3 time points (before the intervention, after 5 months (at the end of the intervention) and 3 months later)
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
Time Frame: A measure assessing change between 3 time points (before the intervention, after 5 months (at the end of the intervention) and 3 months later)
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
Time Frame: A measure assessing change between 3 time points (before the intervention, after 5 months (at the end of the intervention) and 3 months later)
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
Time Frame: A measure assessing change between 3 time points (before the intervention, after 5 months (at the end of the intervention) and 3 months later)
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
Time Frame: A measure assessing change between 3 time points (before the intervention, after 5 months (at the end of the intervention) and 3 months later)
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
Time Frame: A measure assessing change between 3 time points (before the intervention, after 5 months (at the end of the intervention) and 3 months later)
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
Time Frame: A measure assessing change between 3 time points (before the intervention, after 5 months (at the end of the intervention) and 3 months later)
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
Time Frame: A measure assessing change between 3 time points (before the intervention, after 5 months (at the end of the intervention) and 3 months later)
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
Time Frame: A measure assessing change between 3 time points (before the intervention, after 5 months (at the end of the intervention) and 3 months later)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sheba Medical Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Eitan Friedman, Prof., Sheba Medical Center
  • Principal Investigator: Carla Landau, Ph.D Student, Tel Aviv University
  • Principal Investigator: Shahar Lev- Ari, Dr., Tel Aviv University
  • Principal Investigator: Laura Rosen, Dr., Tel Aviv University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2017

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2020

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 7, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 19, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 22, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 7, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 5, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SHEBA-17-3856-EF-CTIL

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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