Pilot Clinical Trial (Phase II) of Inquiry-based Stress Reduction (IBSR) Program for Survivors of Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01244087
Recruitment Status : Completed
First Posted : November 19, 2010
Last Update Posted : June 14, 2013
Oncology Specialists, S.C.
Information provided by (Responsible Party):
Tel-Aviv Sourasky Medical Center

Brief Summary:

The IBSR (Inquiry-based stress reduction) intervention, developed by Byron Katie (, trains subjects 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 can be easily implemented in daily life.

Therefore, on the basis of previous data and beneficial observations the investigators postulate that the clinical utility of IBSR mediation program may improve psychological and physical symptoms and quality of life among BC patients during the survivorship period. Thus, we will conduct a pilot/feasibility randomized controlled clinical trial designed to

  • Assess feasibility of a IBSR intervention by examining attendance, drop-out rates, and program satisfaction.
  • Determine whether IBSR intervention compared with usual care is efficacious in improving quality of life, psychological and physical status in BC survivors.

Condition or disease
Inquiry Based Stress Reduction

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Pilot Clinical Trial (Phase II) of Inquiry-based Stress Reduction (IBSR) Program for Survivors of Breast Cancer
Study Start Date : December 2010
Actual Primary Completion Date : December 2011
Actual Study Completion Date : May 2013

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Women aged 21 or older previously diagnosed with Stage 0-III BC who underwent surgery and received adjuvant or neo-adjuvant chemotherapy and/or radiation will be recruited

Inclusion Criteria:

  1. Bx proven breast cancer
  2. Known disease stage
  3. Subjects completed treatment within the prior 18 months
  4. Subjects are able to read and speak Hebrew at the ninth grade level or higher, as will be judged by their ability to complete a battery of self-report measures
  5. Willing to sign an informed consent
  6. Age 21-70

Exclusion Criteria:

  1. Stage IV BC
  2. Prophylactic mastectomy prior to the current treatment for BC
  3. Severe psychiatric diagnosis (e.g. bipolar disorder)
  4. Treatment for recurrent BC

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01244087

Sourasky M.C.Oncology Department
Tel Aviv, Israel, 64239
Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
Oncology Specialists, S.C.
Principal Investigator: Ilan Ron, MD Sourasky M.C.

Responsible Party: Tel-Aviv Sourasky Medical Center Identifier: NCT01244087     History of Changes
Other Study ID Numbers: IBSR
First Posted: November 19, 2010    Key Record Dates
Last Update Posted: June 14, 2013
Last Verified: June 2013

Keywords provided by Tel-Aviv Sourasky Medical Center:
Inquiry-based stress reduction
Quality of life
breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases