- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01367639
Trial of Inquiry Based Stress Reduction (IBSR) Program for BRCA1/2 Mutation Carriers
Pilot Randomized Controlled Trial of Inquiry Based Stress Reduction (IBSR) Program for BRCA1/2 Mutation Carriers
Study Overview
Status
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Tel-aviv, Israel, 52621
- Sheba Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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).
Study Plan
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 |
Intervention / Treatment |
---|---|
Experimental: intervention
Inquiry Based Stress Reduction (IBSR) program
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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
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
global psychology functioning(GSI)
Time Frame: 12 Weeks
|
12 Weeks
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Sleep quality (PSQI)
Time Frame: 12 weeks
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12 weeks
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Family support PSS-Fa
Time Frame: 12 weeks
|
12 weeks
|
cancer related worry (CRW)
Time Frame: 12 weeks
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12 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Eitan Friedman, Prof., Sheba Medical Center
- Study Director: Shahar Lev-ari, Dr., Department of health promotion, faculty of medicine, Tel Aviv University
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Skin Diseases
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Genital Neoplasms, Female
- Endocrine System Diseases
- Ovarian Diseases
- Adnexal Diseases
- Gonadal Disorders
- Endocrine Gland Neoplasms
- Breast Diseases
- Genetic Diseases, Inborn
- Neoplastic Syndromes, Hereditary
- Ovarian Neoplasms
- Breast Neoplasms
- Hereditary Breast and Ovarian Cancer Syndrome
Other Study ID Numbers
- SHEBA-10-8400-EF-CTIL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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