Ignite Creation Date:
2024-05-05 @ 11:34 PM
Last Modification Date:
2024-10-26 @ 10:36 AM
Study NCT ID:
NCT01367639
Status:
COMPLETED
Last Update Posted:
2013-11-25
First Post:
2011-05-31
Brief Title:
Trial of Inquiry Based Stress Reduction IBSR Program for BRCA12 Mutation Carriers
Sponsor:
Sheba Medical Center
Organization:
Sheba Medical Center
Study Overview
Official Title:
Pilot Randomized Controlled Trial of Inquiry Based Stress Reduction IBSR Program for BRCA12 Mutation Carriers
Status:
COMPLETED
Status Verified Date:
2013-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Breast cancer BC is a major health problem and the most prevalent cancer among womenIn a substantial proportion of familial cases germ-line mutations in either BRCA12 can be detected The only proven modality for active risk reduction rather than passive early detection is prophylactic surgery - prophylactic mastectomy and oophorectomy While the majority of Jewish mutation carriers elect to undergo prophylactic oophorectomy at about age 40 years in Israel only a minority perform prophylactic mastectomy Another ramification of being a mutation carrier is the emotional stress associated with that discoveryGenetic information has profound implications for mutation carriers 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 Therefore on the basis of previous data and beneficial observations we postulate that the clinical utility of IBSR mediation program may improve psychological and physical symptoms and quality of life among asymptomatic oncologically healthy BRCA1 BRCA2 mutation carriers Thus we will conduct a pilot randomized controlled trial to scientifically investigate the effect of this intervention effects on BRCA12 mutation carriers
Detailed Description:
Main Goals To investigate whether IBSR intervention is efficacious in improving quality of life psychological and physical status in BRCA12 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 BRCA12 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
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 BRCA12 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None