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


Phase 2
35 Years
70 Years
Open (Enrolling)
Female
Hereditary Breast and Ovarian Cancer Syndrome

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Trial Information

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


Main Goals: To investigate whether IBSR intervention is efficacious in improving quality of
life, psychological and physical status in BRCA1/2 mutation carriers.

Secondary-goal: To Assess feasibility of IBSR intervention by examining attendance, drop-out
rates, and program satisfaction.

Hypothesis Participants' ability to deal with emotional difficulties will be improved
following participation in the IBSR intervention. This will be reflected in improving the
values of psychological measures, such as quality of sleep, cancer related worry, family
support, depression and anxiety, after the intervention (among participants in the
intervention group, but not in the control group).

Study population: Eligible individuals are women who are carriers of one of the predominant
Jewish mutations in BRCA1/2 genes at the Meirav Center, Sheba Medical center over the past
10 years. All eligible women will be contacted by the staff of the Meirav Center and will be
offered participation during routine follow up visits at the high risk clinic, by phone or a
letter. Interested individuals will be scheduled to attend a meeting at a time of their
convenience with the PI or the Co PIs to explain the study aims and goals. After the
participant has agreed and signed the informed consent she is considered eligible.


Inclusion Criteria:



- Women who are carriers of one of the predominant Jewish mutations in BRCA1/2 genes,
age 35 years or older, 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, self reported Pregnancy,
risk reduction mastectomy, severe psychiatric diagnosis (e.g. bipolar disorder).

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

global psychology functioning(GSI)

Outcome Time Frame:

12 Weeks

Safety Issue:

No

Principal Investigator

Eitan Friedman, Prof.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Sheba Medical Center

Authority:

Israel: Ministry of Health

Study ID:

SHEBA-10-8400-EF-CTIL

NCT ID:

NCT01367639

Start Date:

March 2011

Completion Date:

Related Keywords:

  • Hereditary Breast and Ovarian Cancer Syndrome
  • BRCA 1/2 Carriers
  • IBSR
  • The Work
  • Randomized clinical trial
  • Ovarian Neoplasms

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