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

NCT03162276 | Unknown Phase 3

• 1 other identifier: SHEBA-17-3856-EF-CTIL
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 2

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.

Conditions

Hereditary Breast and Ovarian Cancer Syndrome

Keywords

BRCA 1/2 Carriers; The Work; RCT; IBSR

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Life Orientation Test-Revise- LOT-R

  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

  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

  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

  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

  A measure assessing change between 3 time points (before the intervention, after 5 months (at the end of the intervention) and 3 months later)

Study Arms (2)

Intervention

EXPERIMENTAL

Inquiry Based Stress Reduction

Behavioral: Inquiry Based Stress Reduction (IBSR) program

Control

PLACEBO COMPARATOR

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

Behavioral: Control

Interventions

Inquiry Based Stress Reduction (IBSR) program 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

Intervention

Control BEHAVIORAL

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

Control

Eligibility Criteria

• Age: 25 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Diagnosed with breast or ovarian cancer or any other cancer, risk reduction mastectomy, severe psychiatric diagnosis (e.g. bipolar disorder).

Sponsors & Collaborators

• Sheba Medical Center: lead

Study Sites (2)

Sheba Medical Center

Tel Aviv, 52621, Israel

ENROLLING BY INVITATION

Eitan Friedman

Tel Litwinsky, Israel

RECRUITING

Related Publications (3)

• 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.

  PMID: 25328041 BACKGROUND

• 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

  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.

  PMID: 34962562 DERIVED

MeSH Terms

Conditions

Hereditary Breast and Ovarian Cancer Syndrome

Condition Hierarchy (Ancestors)

Breast Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Neoplasms; Endocrine Gland Neoplasms; Neoplastic Syndromes, Hereditary; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Endocrine System Diseases; Gonadal Disorders

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eitan Friedman, Prof.

CONTACT

972-3-5303173; eitan.friedman@sheba.health.gov.il

Shahar Lev- Ari, Dr.

CONTACT

shaharl@tlv.gov.il

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2017
• First Posted: May 22, 2017
• Study Start: July 1, 2017
• Primary Completion: October 1, 2020
• Study Completion: December 30, 2020
• Last Updated: September 7, 2018

Record last verified: 2018-09

Locations

IL (2)