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

This study has been completed.
Sponsor:
Collaborator:
Oncology Specialists, S.C.
Information provided by (Responsible Party):
Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier:
NCT01244087
First received: November 9, 2010
Last updated: June 13, 2013
Last verified: June 2013
  Purpose

The IBSR (Inquiry-based stress reduction) intervention, developed by Byron Katie (www.thework.com), 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
Inquiry Based Stress Reduction

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Tel-Aviv Sourasky Medical Center:

Estimated Enrollment: 30
Study Start Date: December 2010
Study Completion Date: May 2013
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders 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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01244087

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

No publications provided

Responsible Party: Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier: NCT01244087     History of Changes
Other Study ID Numbers: IBSR
Study First Received: November 9, 2010
Last Updated: June 13, 2013
Health Authority: Israel: Ethics Commission

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

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

ClinicalTrials.gov processed this record on October 23, 2014