Hereditary Breast and Ovarian Cancer Syndrome Clinical Trial
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 BRCA1/2 Carriers: A Randomized Controlled Trial, RCT.
Breast cancer (BC) is a major health problem and the most prevalent cancer among women.In a substantial proportion of familial cases, germ-line mutations in either BRCA1/2 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 discovery.Genetic 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 BRCA1/2 mutation carriers.
Status | Recruiting |
Enrollment | 118 |
Est. completion date | December 30, 2020 |
Est. primary completion date | October 1, 2020 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 25 Years to 55 Years |
Eligibility |
Inclusion Criteria: - Women who are carriers of one of the predominant Jewish mutations in BRCA1/2 genes, age 25-55 years, with no current or past history of cancer (except BCC), who are willing to sign an informed consent, and present mental clarity by the ability to comprehend and fulfill all the questionnaires. Exclusion Criteria: - Diagnosed with breast or ovarian cancer or any other cancer, risk reduction mastectomy, severe psychiatric diagnosis (e.g. bipolar disorder). |
Country | Name | City | State |
---|---|---|---|
Israel | Eitan Friedman | Tel Hashomer | |
Israel | Sheba Medical Center | Tel-aviv |
Lead Sponsor | Collaborator |
---|---|
Sheba Medical Center |
Israel,
Landau C, Lev-Ari S, Cohen-Mansfield J, Tillinger E, Geva R, Tarrasch R, Mitnik I, Friedman E. Randomized controlled trial of Inquiry-Based Stress Reduction (IBSR) technique for BRCA1/2 mutation carriers. Psychooncology. 2015 Jun;24(6):726-31. doi: 10.1002/pon.3703. Epub 2014 Oct 18. — View Citation
Landau C, Mitnik I, Cohen-Mensfild J, Tillinger E, Geva R, , Friedman E. Lev-Ari S. Inquiry-based stress reduction (IBSR) meditation technique for brCA1/2 mutation carriers—A qualitative study. European Journal of Integrative Medicine; Dec 2016; 8 (6): 958-964
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The Ryff scale- Psychological well-being | Questionnaire | A measure assessing change between 3 time points (before the intervention, after 5 months (at the end of the intervention) and 3 months later) | |
Secondary | Life Orientation Test-Revise- LOT-R | This questionnaire assesses the degree of optimism | A measure assessing change between 3 time points (before the intervention, after 5 months (at the end of the intervention) and 3 months later) | |
Secondary | Satisfaction with life scale - SWLS d | This questionnaire assesses the degree of Satisfaction with the life | A measure assessing change between 3 time points (before the intervention, after 5 months (at the end of the intervention) and 3 months later) | |
Secondary | Pittsburgh Sleep Quality Inventory Questionnaire- PSQI | This questionnaire assesses the quality of sleep | A measure assessing change between 3 time points (before the intervention, after 5 months (at the end of the intervention) and 3 months later) | |
Secondary | Positive and negative affect schedule PANAS | This questionnaire assesses the degree of positive and negative feelings | A measure assessing change between 3 time points (before the intervention, after 5 months (at the end of the intervention) and 3 months later) | |
Secondary | Self-assessed health SAH | This questionnaire assesses the personal perceived health | A measure assessing change between 3 time points (before the intervention, after 5 months (at the end of the intervention) and 3 months later) | |
Secondary | Euroqol quality of life scale EQ-5D | This questionnaire assesses the quality of life | A measure assessing change between 3 time points (before the intervention, after 5 months (at the end of the intervention) and 3 months later) | |
Secondary | Perceived social support from family PSS-FA | This questionnaire assesses the perceived family support | A measure assessing change between 3 time points (before the intervention, after 5 months (at the end of the intervention) and 3 months later) | |
Secondary | Mindfulness attention awareness scale MAAS | This questionnaire assesses the degree of mindfulness attention | A measure assessing change between 3 time points (before the intervention, after 5 months (at the end of the intervention) and 3 months later) | |
Secondary | General self- efficacy GSE | This questionnaire assesses the degree of self- efficacy | A measure assessing change between 3 time points (before the intervention, after 5 months (at the end of the intervention) and 3 months later) | |
Secondary | Demographic and behavioral data | This questionnaire asks about demographics data and health behavior | A measure assessing change between 3 time points (before the intervention, after 5 months (at the end of the intervention) and 3 months later) |
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