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

Sheba Medical Center

Status and phase: Unknown; Phase 3

Conditions: Hereditary Breast and Ovarian Cancer Syndrome

Treatments: Behavioral: Control; Behavioral: Inquiry Based Stress Reduction (IBSR) program

Study type: Interventional

Funder types: Other

Identifiers

NCT03162276

SHEBA-17-3856-EF-CTIL

Details and patient eligibility

About

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.

Full 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.

Enrollment: 118 estimated patients

Sex: Female

Ages: 25 to 55 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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118 participants in 2 patient groups, including a placebo group

Intervention

Experimental group

Description:

Inquiry Based Stress Reduction

Treatment:

Behavioral: Inquiry Based Stress Reduction (IBSR) program

Control

Placebo Comparator group

Description:

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

Treatment:

Behavioral: Control