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

NCT01244087 | Completed

• 1 other identifier: IBSR
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Inquiry Based Stress Reduction

Keywords

Inquiry-based stress reduction; Quality of life; breast cancer

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Bx proven breast cancer
• Known disease stage
• Subjects completed treatment within the prior 18 months
• 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
• Willing to sign an informed consent
• Age 21-70

You may not qualify if:

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

Sponsors & Collaborators

• Tel-Aviv Sourasky Medical Center: lead
• Oncology Specialists, S.C.: collaborator

Study Sites (1)

Sourasky M.C.Oncology Department

Tel Aviv, 64239, Israel

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Ilan Ron, MD

  Sourasky M.C.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2010
• First Posted: November 19, 2010
• Study Start: December 1, 2010
• Primary Completion: December 1, 2011
• Study Completion: May 1, 2013
• Last Updated: June 14, 2013

Record last verified: 2013-06

Locations

IL (1)