Ignite Creation Date:
2024-05-06 @ 10:06 AM
Last Modification Date:
2024-10-26 @ 12:24 PM
Study NCT ID:
NCT03162276
Status:
UNKNOWN
Last Update Posted:
2018-09-07
First Post:
2017-05-07
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:
Evaluating the Effectiveness of Inquiry Based Stress Reduction IBSR Intervention Versus Regular Care of no Treatment on Well-being Optimism and Health Behavior of BRCA12 Carriers A Randomized Controlled Trial RCT
Status:
UNKNOWN
Status Verified Date:
2018-09
Last Known Status:
RECRUITING
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:
Primary goal to evaluate the effectiveness of IBSR intervention on psychological well-being of BRCA carriers
Secondary goals
To understand the IBSR action mechanism and to develop a theoretical model
To examine the correlation between psychological well-being and optimism and health behaviors among carriers
To evaluate and define core beliefs related to psychological well-being optimism and expectations among carriers
To evaluate and define the health related behaviors among carriers
Rationale for studies The rationale of the research emerges from two aspects One aspect is the effort to establish a new intervention program for women in order to help them deal with the daily implications of being a BRCA carrier Up to date only few interventions were carried out in Israel and worldwide and had several methodological limitations
The other aspect is the combination of quantitative and qualitative tools in order to analyze the psychological implications of a complicated medical state and to establish an intervention program in order to reduce their adverse impact This combination can significantly contribute to the understanding of the investigated issue and the participants experience The current research is comprehensive and rigorous and it is based on a randomized controlled study which was carried out with 118 Israeli women
Research plan and milestones
Research Design A randomized controlled study offering IBSR intervention for BRCA carriers
Research sample 118 asymptomatic BRCA12 carriers being followed-up in the high-risk clinic at Sheba hospital and meet the inclusion criteria
asymptomatic carriers of BRCA12 mutation level of Hebrew age group and psychiatric illness Age 25-55
Intervention group 59 carriers who will participate in a 8-12 sessions up to 48 hours group workshop of IBSR
Control group 59 carriers who will not participate in the workshop They will complete questionnaires on the same time points as the intervention group Participants who completed all the questionnaires will receive an IBSR kit for home practice
Research outcomes psychological well-being optimism satisfaction with life mental well-being quality of sleep health behaviors and perceptions In addition the main themes from the qualitative interviews
Secondary goals
To understand the IBSR action mechanism and to develop a theoretical model
To examine the correlation between psychological well-being and optimism and health behaviors among carriers
To evaluate and define core beliefs related to psychological well-being optimism and expectations among carriers
To evaluate and define the health related behaviors among carriers
Rationale for studies The rationale of the research emerges from two aspects One aspect is the effort to establish a new intervention program for women in order to help them deal with the daily implications of being a BRCA carrier Up to date only few interventions were carried out in Israel and worldwide and had several methodological limitations
The other aspect is the combination of quantitative and qualitative tools in order to analyze the psychological implications of a complicated medical state and to establish an intervention program in order to reduce their adverse impact This combination can significantly contribute to the understanding of the investigated issue and the participants experience The current research is comprehensive and rigorous and it is based on a randomized controlled study which was carried out with 118 Israeli women
Research plan and milestones
Research Design A randomized controlled study offering IBSR intervention for BRCA carriers
Research sample 118 asymptomatic BRCA12 carriers being followed-up in the high-risk clinic at Sheba hospital and meet the inclusion criteria
asymptomatic carriers of BRCA12 mutation level of Hebrew age group and psychiatric illness Age 25-55
Intervention group 59 carriers who will participate in a 8-12 sessions up to 48 hours group workshop of IBSR
Control group 59 carriers who will not participate in the workshop They will complete questionnaires on the same time points as the intervention group Participants who completed all the questionnaires will receive an IBSR kit for home practice
Research outcomes psychological well-being optimism satisfaction with life mental well-being quality of sleep health behaviors and perceptions In addition the main themes from the qualitative interviews
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None