Hereditary Breast and Ovarian Cancer SyndromePhase 3NCT03162276
Trial of Inquiry Based Stress Reduction (IBSR) Program for BRCA1/2 Mutation Carriers
A Phase 3 study testing Inquiry Based Stress Reduction (IBSR) program in people with Hereditary Breast and Ovarian Cancer Syndrome, run by Sheba Medical Center at 2 sites in Israel.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 25 to 55 years, women only
- Conditions the study is for
- Hereditary Breast and Ovarian Cancer Syndrome
- What is being tested?
- Inquiry Based Stress Reduction (IBSR) program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 118 participants
- Where
- 2 sitesIsrael
- Study dates
- 1 Jul 2017to 30 Dec 2020
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- Diagnosed with breast or ovarian cancer or any other cancer, risk reduction mastectomy, severe psychiatric diagnosis (e.g. bipolar disorder).
Trial locations and contacts
2 sites in 1 country.
Shahar Lev- Ari, Dr. contact
Israel2 sites, 2 recruiting
- Enrolling by invitation
Sheba Medical Center
Tel Aviv, 52621
- Recruiting
Eitan Friedman
Tel Litwinsky
Eitan Friedman, Prof
About this study
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.
Read the 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 BRCA1/2 carriers, being followed-up in the high-risk clinic at Sheba hospital and meet the inclusion criteria:
asymptomatic carriers of BRCA1/2 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.
- Being tested
- Inquiry Based Stress Reduction (IBSR) program, Control
- Keywords
- BRCA 1/2 Carriers, The Work, RCT, IBSR
- Medical subject headings
- Hereditary Breast and Ovarian Cancer Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inquiry Based Stress Reduction (IBSR) programBehavioural
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
ControlBehavioural
At end of intervention, the control group will receive a brief intervention consisting of a home kit for practicing IBSR techniques.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Inquiry Based Stress Reduction Receives: Behavioral: Inquiry Based Stress Reduction (IBSR) program |
| Control | Placebo comparator | The placebo group participants will receive a modified form of the intervention at the close of the study Receives: Behavioral: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Ryff scale- Psychological well-being
Questionnaire
Measured: 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 outcomes (10)
Life Orientation Test-Revise- LOT-R
This questionnaire assesses the degree of optimism
Measured: A measure assessing change between 3 time points (before the intervention, after 5 months (at the end of the intervention) and 3 months later)
Satisfaction with life scale - SWLS d
This questionnaire assesses the degree of Satisfaction with the life
Measured: A measure assessing change between 3 time points (before the intervention, after 5 months (at the end of the intervention) and 3 months later)
Pittsburgh Sleep Quality Inventory Questionnaire- PSQI
This questionnaire assesses the quality of sleep
Measured: A measure assessing change between 3 time points (before the intervention, after 5 months (at the end of the intervention) and 3 months later)
Positive and negative affect schedule PANAS
This questionnaire assesses the degree of positive and negative feelings
Measured: A measure assessing change between 3 time points (before the intervention, after 5 months (at the end of the intervention) and 3 months later)
Self-assessed health SAH
This questionnaire assesses the personal perceived health
Measured: A measure assessing change between 3 time points (before the intervention, after 5 months (at the end of the intervention) and 3 months later)
Euroqol quality of life scale EQ-5D
This questionnaire assesses the quality of life
Measured: A measure assessing change between 3 time points (before the intervention, after 5 months (at the end of the intervention) and 3 months later)
Perceived social support from family PSS-FA
This questionnaire assesses the perceived family support
Measured: A measure assessing change between 3 time points (before the intervention, after 5 months (at the end of the intervention) and 3 months later)
Mindfulness attention awareness scale MAAS
This questionnaire assesses the degree of mindfulness attention
Measured: A measure assessing change between 3 time points (before the intervention, after 5 months (at the end of the intervention) and 3 months later)
General self- efficacy GSE
This questionnaire assesses the degree of self- efficacy
Measured: A measure assessing change between 3 time points (before the intervention, after 5 months (at the end of the intervention) and 3 months later)
Demographic and behavioral data
This questionnaire asks about demographics data and health behavior
Measured: A measure assessing change between 3 time points (before the intervention, after 5 months (at the end of the intervention) and 3 months later)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2017
- Study start1 Jul 2017
- Primary completion1 Oct 2020 (estimated)
- Study completion30 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Hereditary Breast and Ovarian Cancer SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 118 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Eitan Friedman, Prof., Principal investigator, Sheba Medical CenterCarla Landau, Ph.D Student, Principal investigator, Tel Aviv UniversityShahar Lev- Ari, Dr., Principal investigator, Tel Aviv UniversityLaura Rosen, Dr., Principal investigator, Tel Aviv University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03162276
- Sponsor's protocol ID
- SHEBA-17-3856-EF-CTIL
- Status last verified
- Sep 2018
- First submitted
- 7 May 2017
- Last updated
- 7 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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. No abstract available.
PubMed 25328041Landau 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
Landau C, Novak AM, Ganz AB, Rolnik B, Friedman E, Lev-Ari S. Effect of Inquiry-Based Stress Reduction on Well-being and Views on Risk-Reducing Surgery Among Women With BRCA Variants in Israel: A Randomized Clinical Trial. JAMA Netw Open. 2021 Dec 1;4(12):e2139670. doi: 10.1001/jamanetworkopen.2021.39670.
PubMed 34962562
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT03162276
- Acronym / sponsor ID
- SHEBA-17-3856-EF-CTIL
- Keywords
- BRCA 1/2 Carriers, The Work, RCT, IBSR
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 118 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 1 Oct 2020 (estimated)
- Study completion
- 30 Dec 2020 (estimated)
- First posted
- 22 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 BRCA1/2 carriers, being followed-up in the high-risk clinic at Sheba hospital and meet the inclusion criteria:
asymptomatic carriers of BRCA1/2 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Inquiry Based Stress Reduction (IBSR) programInquiry Based Stress Reduction |
| Control | Placebo comparator | Behavioral: ControlThe placebo group participants will receive a modified form of the intervention at the close of the study |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Diagnosed with breast or ovarian cancer or any other cancer, risk reduction mastectomy, severe psychiatric diagnosis (e.g. bipolar disorder).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inquiry Based Stress Reduction (IBSR) programThe 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 | Behavioural | Intervention |
| ControlAt end of intervention, the control group will receive a brief intervention consisting of a home kit for practicing IBSR techniques. | Behavioural | Control |
Primary outcome
The Ryff scale- Psychological well-being
Time frame: A measure assessing change between 3 time points (before the intervention, after 5 months (at the end of the intervention) and 3 months later)
Questionnaire
10 secondary outcomes
Life Orientation Test-Revise- LOT-R
Time frame: A measure assessing change between 3 time points (before the intervention, after 5 months (at the end of the intervention) and 3 months later)
Satisfaction with life scale - SWLS d
Time frame: A measure assessing change between 3 time points (before the intervention, after 5 months (at the end of the intervention) and 3 months later)
Pittsburgh Sleep Quality Inventory Questionnaire- PSQI
Time frame: A measure assessing change between 3 time points (before the intervention, after 5 months (at the end of the intervention) and 3 months later)
Positive and negative affect schedule PANAS
Time frame: A measure assessing change between 3 time points (before the intervention, after 5 months (at the end of the intervention) and 3 months later)
Self-assessed health SAH
Time frame: A measure assessing change between 3 time points (before the intervention, after 5 months (at the end of the intervention) and 3 months later)
Euroqol quality of life scale EQ-5D
Time frame: A measure assessing change between 3 time points (before the intervention, after 5 months (at the end of the intervention) and 3 months later)
Perceived social support from family PSS-FA
Time frame: A measure assessing change between 3 time points (before the intervention, after 5 months (at the end of the intervention) and 3 months later)
Mindfulness attention awareness scale MAAS
Time frame: A measure assessing change between 3 time points (before the intervention, after 5 months (at the end of the intervention) and 3 months later)
General self- efficacy GSE
Time frame: A measure assessing change between 3 time points (before the intervention, after 5 months (at the end of the intervention) and 3 months later)
Demographic and behavioral data
Time frame: A measure assessing change between 3 time points (before the intervention, after 5 months (at the end of the intervention) and 3 months later)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2018.
- Background: PubMed 25328041Landau 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. No abstract available.
- BackgroundLandau 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
- Derived from this study: PubMed 34962562Landau C, Novak AM, Ganz AB, Rolnik B, Friedman E, Lev-Ari S. Effect of Inquiry-Based Stress Reduction on Well-being and Views on Risk-Reducing Surgery Among Women With BRCA Variants in Israel: A Randomized Clinical Trial. JAMA Netw Open. 2021 Dec 1;4(12):e2139670. doi: 10.1001/jamanetworkopen.2021.39670.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shahar Lev- Ari, Dr. contact
Eitan Friedman, Prof. principal investigator
Sheba Medical Center
Carla Landau, Ph.D Student principal investigator
Tel Aviv University
Shahar Lev- Ari, Dr. principal investigator
Tel Aviv University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Inquiry Based Stress Reduction (IBSR) program in people with Hereditary Breast and Ovarian Cancer Syndrome, run by Sheba Medical Center at 2 sites in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eitan Friedman, Prof. (972-3-5303173, eitan.friedman@sheba.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Ryff scale- Psychological well-being (time frame: A measure assessing change between 3 time points (before the intervention, after 5 months (at the end of the intervention) and 3 months later)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03162276, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2018.