Pilot Clinical Trial (Phase II) of Inquiry-based Stress Reduction (IBSR) Program for Survivors of Breast Cancer
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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 |
| 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 |
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:
- 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
Exclusion Criteria:
- Stage IV BC
- Prophylactic mastectomy prior to the current treatment for BC
- Severe psychiatric diagnosis (e.g. bipolar disorder)
- Treatment for recurrent BC
Contacts and Locations| Israel | |
| Sourasky M.C.Oncology Department | |
| Tel Aviv, Israel, 64239 | |
| 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 Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |
ClinicalTrials.gov processed this record on June 17, 2013