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

NCT ID: NCT03162276

Last Updated: 2018-09-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 118 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-01
• Study Completion Date: 2020-12-30

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.

Conditions

Hereditary Breast and Ovarian Cancer Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention

Inquiry Based Stress Reduction

Group Type: EXPERIMENTAL

Inquiry Based Stress Reduction (IBSR) program

Intervention Type: BEHAVIORAL

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

Control

The placebo group participants will receive a modified form of the intervention at the close of the study

Group Type: PLACEBO_COMPARATOR

Control

Intervention Type: BEHAVIORAL

At end of intervention, the control group will receive a brief intervention consisting of a home kit for practicing IBSR techniques.

Interventions

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

Intervention Type: BEHAVIORAL

Control

At end of intervention, the control group will receive a brief intervention consisting of a home kit for practicing IBSR techniques.

Intervention Type: BEHAVIORAL

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).

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Sheba Medical Center

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Eitan Friedman, Prof.

Role: PRINCIPAL_INVESTIGATOR

Sheba Medical Center

Carla Landau, Ph.D Student

Role: PRINCIPAL_INVESTIGATOR

Tel Aviv University

Shahar Lev- Ari, Dr.

Role: PRINCIPAL_INVESTIGATOR

Tel Aviv University

Laura Rosen, Dr.

Role: PRINCIPAL_INVESTIGATOR

Tel Aviv University

Locations

Sheba Medical Center

Tel Aviv, , Israel

Site Status: ENROLLING_BY_INVITATION

Eitan Friedman

Tel Litwinsky, , Israel

Site Status: RECRUITING

Countries

Israel

Central Contacts

Eitan Friedman, Prof.

Role: CONTACT

eitan.friedman@sheba.health.gov.il

972-3-5303173

Shahar Lev- Ari, Dr.

Role: CONTACT

shaharl@tlv.gov.il

Facility Contacts

Eitan Friedman, Prof

Role: primary

References

Landau C, Lev-Ari S, Cohen-Mansfield J, Tillinger E, Geva R, Tarrasch R, Mitnik I, Friedman E. Randomized controlled trial of Inquiry-Based Stress Reduction (IBSR) technique for BRCA1/2 mutation carriers. Psychooncology. 2015 Jun;24(6):726-31. doi: 10.1002/pon.3703. Epub 2014 Oct 18. No abstract available.

Reference Type: BACKGROUND

PMID: 25328041 (View on PubMed)

Landau C, Mitnik I, Cohen-Mensfild J, Tillinger E, Geva R, , Friedman E. Lev-Ari S. Inquiry-based stress reduction (IBSR) meditation technique for brCA1/2 mutation carriers-A qualitative study. European Journal of Integrative Medicine; Dec 2016; 8 (6): 958-964

Reference Type: BACKGROUND

Landau C, Novak AM, Ganz AB, Rolnik B, Friedman E, Lev-Ari S. Effect of Inquiry-Based Stress Reduction on Well-being and Views on Risk-Reducing Surgery Among Women With BRCA Variants in Israel: A Randomized Clinical Trial. JAMA Netw Open. 2021 Dec 1;4(12):e2139670. doi: 10.1001/jamanetworkopen.2021.39670.

Reference Type: DERIVED

PMID: 34962562 (View on PubMed)

Other Identifiers

SHEBA-17-3856-EF-CTIL

Identifier Type: -

Identifier Source: org_study_id