CancerPhase 2IBSRNCT01795404
A Randomized Controlled Trial of Inquiry Based Stress Reduction (IBSR) Program for Cancer Survivors.
A Phase 2 study testing Inquiry Based Stress Reduction (IBSR) in people with Cancer, run by Tel-Aviv Sourasky Medical Center.
Trial summary
A cancer diagnosis is a stressful phenomenon and a life-threatening experience that creates immediate psychosocial distress for the patient and his or her family. Distress is also experienced across the disease trajectory. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Cancer
- What is being tested?
- Inquiry Based Stress Reduction (IBSR)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- Jun 2013to Dec 2016
- Phase
- Phase 2
- 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants who were diagnosed with either:Breast cancer;Colorectal cancer;Prostate cancer.
- 18 years and older;
- Awareness of their cancer diagnosis;
- Within three months to eighteen months after the completion of surgery, chemotherapy, and/or radiotherapy.
- Able to read and complete questionnaires on their own.
Who cannot join
- Participants not speaking Hebrew;
- Not able to give informed consent due to impaired mental or intellectual state
- Advanced cancer stage
- Current psychiatric diagnosis
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Randomized Controlled Trial of Inquiry Based Stress Reduction (IBSR) Program for Cancer Survivors - Effects on Quality of Life, Psychological Measures,Physical Symptoms, and Biological Measurements.
A cancer diagnosis is a stressful phenomenon and a life-threatening experience that creates immediate psychosocial distress for the patient and his or her family. Distress is also experienced across the disease trajectory. Stress can manifest in a variety of psychological symptoms, such as anxiety and depression, intrusive cancer-related thoughts, or physical symptoms, such as fatigue, increased pain, and impaired sleep. Intensified stress in cancer patients has been associated with increased morbidity and mortality, decreased immune function, increased relapse, and decreased health-related quality of life. Given the known negative impact of stress on cancer patients, stress has become a priority issue in cancer treatment and research. Targeting stress-related variables with psychosocial interventions has been an important emphasis in cancer-care models. One of these care modalities is Inquiry-based stress reduction.
The IBSR intervention, developed by Byron Katie, is a simple yet powerful process of inquiry that teaches the individual to identify and question the thoughts that cause him or her to experience stress and suffering. It is a way to understand what is hurting the individual, and to address the cause of his or her problems with clarity. This mindful-process, named "The Work", facilitates that through four questions and a turnaround, which is a way of experiencing the opposite of what the individual believes in. The Work provides skills for self-inquiry and management of stressful thoughts which can be easily implemented in daily life. The study will focus on breast, colorectal and prostate cancer patients. These types of cancers have high incidence along with high survival rates.
Read more
The primary objective is to examine the feasibility and effectiveness of IBSR for breast, colorectal and prostate cancer survivors on quality of life. We hypothesize that this intervention will lead to significant improvements in all quality of life domains (physical well-being, psychological well-being, social well-being etc.)
Effects on secondary outcomes will be assessed, including depressive symptoms, anxiety and stress levels, and fear of recurrence. Physical symptoms (disturbance in sleeping patterns, fatigue, and pain), will be assessed as well. Biological measurements will be measured in blood samples in order to observe effects on neural and immune components.
Additionally, we are interested in evaluating whether positive effects achieved from the IBSR program are modified by specific patient characteristics measured at baseline (optimism, social support, and spirituality).
- Conditions
- Cancer
- Being tested
- Inquiry Based Stress Reduction (IBSR)
- Keywords
- IBSR, Cancer Survivors, Katie Byron, Quality of Life, Stress, Stress reduction
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inquiry Based Stress Reduction (IBSR)Behavioural
Also called The Work meditation (Byron Katie)
| Study group | Role | What they receive |
|---|---|---|
| Inquiry Based Stress Reduction (IBSR) Program | Experimental | During a 12-week intervention program, participants will be encouraged to identify and inquire their stressful thoughts. Through the use of self-inquiry practices participants are taught to increase awareness of their thoughts and feelings, to observe their emotional and physical responses during situations perceived by them as stressful, and allow their mind to return to its true, peaceful, creative nature. Through the process of self-inquiry, participants take an active role in investigating their stressful thoughts, and by this regulating their stress and managing symptoms and emotions, thus enabling them to cope better with the distress related to the possibility of cancer. Receives: Behavioral: Inquiry Based Stress Reduction (IBSR) |
| Control group | No intervention | Waited-list control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Life (QoL)
Validated 41 items questionnaire will be used to assess QoL, including:
Measures of psychological status: Fear of recurrence, perceived stress, anxiety, and depressive symptoms.
Physical symptoms: Fatigue, pain, sleep disturbance. Social concerns Spiritual well being
Measured: All participants will be asked to fill the same questionnaires at the initiation of the study (T1) and again after 3 months (end of intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2013 (estimated)
- Study startJun 2013
- Primary completionJun 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Nadir Arber, Prof., Principal investigator, Tel Aviv Medical CenterShahar LevAri, PhD, Study director, Tel Aviv Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01795404
- Sponsor's protocol ID
- TASMC-13-NA-549-CTIL
- Acronym
- IBSR
- Status last verified
- Feb 2013
- First submitted
- 17 Feb 2013
- Last updated
- 20 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Inquiry Based Stress Reduction (IBSR) Program for Cancer Survivors - Effects on Quality of Life, Psychological Measures,Physical Symptoms, and Biological Measurements.
- ClinicalTrials.gov ID
- NCT01795404
- Acronym / sponsor ID
- IBSR / TASMC-13-NA-549-CTIL
- Conditions
- Cancer
- Keywords
- IBSR, Cancer Survivors, Katie Byron, Quality of Life, Stress, Stress reduction
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- Jun 2013
- Primary completion
- Jun 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 20 Feb 2013 (estimated)
- 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.
A cancer diagnosis is a stressful phenomenon and a life-threatening experience that creates immediate psychosocial distress for the patient and his or her family. Distress is also experienced across the disease trajectory. Stress can manifest in a variety of psychological symptoms, such as anxiety and depression, intrusive cancer-related thoughts, or physical symptoms, such as fatigue, increased pain, and impaired sleep. Intensified stress in cancer patients has been associated with increased morbidity and mortality, decreased immune function, increased relapse, and decreased health-related quality of life. Given the known negative impact of stress on cancer patients, stress has become a priority issue in cancer treatment and research. Targeting stress-related variables with psychosocial interventions has been an important emphasis in cancer-care models. One of these care modalities is Inquiry-based stress reduction.
The IBSR intervention, developed by Byron Katie, is a simple yet powerful process of inquiry that teaches the individual to identify and question the thoughts that cause him or her to experience stress and suffering. It is a way to understand what is hurting the individual, and to address the cause of his or her problems with clarity. This mindful-process, named "The Work", facilitates that through four questions and a turnaround, which is a way of experiencing the opposite of what the individual believes in. The Work provides skills for self-inquiry and management of stressful thoughts which can be easily implemented in daily life. The study will focus on breast, colorectal and prostate cancer patients. These types of cancers have high incidence along with high survival rates.
The primary objective is to examine the feasibility and effectiveness of IBSR for breast, colorectal and prostate cancer survivors on quality of life. We hypothesize that this intervention will lead to significant improvements in all quality of life domains (physical well-being, psychological well-being, social well-being etc.)
Effects on secondary outcomes will be assessed, including depressive symptoms, anxiety and stress levels, and fear of recurrence. Physical symptoms (disturbance in sleeping patterns, fatigue, and pain), will be assessed as well. Biological measurements will be measured in blood samples in order to observe effects on neural and immune components.
Additionally, we are interested in evaluating whether positive effects achieved from the IBSR program are modified by specific patient characteristics measured at baseline (optimism, social support, and spirituality).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Inquiry Based Stress Reduction (IBSR) Program | Experimental | Behavioral: Inquiry Based Stress Reduction (IBSR)During a 12-week intervention program, participants will be encouraged to identify and inquire their stressful thoughts. Through the use of self-inquiry practices participants are taught to increase awareness of their thoughts and feelings, to observe their emotional and physical responses during situations perceived by them as stressful, and allow their mind to return to its true, peaceful, creative nature. Through the process of self-inquiry, participants take an active role in investigating their stressful thoughts, and by this regulating their stress and managing symptoms and emotions, thus enabling them to cope better with the distress related to the possibility of cancer. |
| Control group | No intervention | –Waited-list control |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Participants who were diagnosed with either:Breast cancer;Colorectal cancer;Prostate cancer.
- 18 years and older;
- Awareness of their cancer diagnosis;
- Within three months to eighteen months after the completion of surgery, chemotherapy, and/or radiotherapy.
- Able to read and complete questionnaires on their own.
Key exclusion criteria (4 listed)
- Participants not speaking Hebrew;
- Not able to give informed consent due to impaired mental or intellectual state
- Advanced cancer stage
- Current psychiatric diagnosis
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)Also: The Work meditation (Byron Katie) | Behavioural | Inquiry Based Stress Reduction (IBSR) Program |
Primary outcome
Quality of Life (QoL)
Time frame: All participants will be asked to fill the same questionnaires at the initiation of the study (T1) and again after 3 months (end of intervention)
Validated 41 items questionnaire will be used to assess QoL, including: Measures of psychological status: Fear of recurrence, perceived stress, anxiety, and depressive symptoms. Physical symptoms: Fatigue, pain, sleep disturbance. Social concerns Spiritual well being
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2013.
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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.
Nadir Arber, Prof. principal investigator
Tel Aviv Medical Center
Shahar LevAri, PhD study director
Tel Aviv Medical Center
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Inquiry Based Stress Reduction (IBSR) in people with Cancer, run by Tel-Aviv Sourasky Medical Center.
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 5 inclusion and 4 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 20 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Nadir Arber, Prof. (972-3-6974968, nadira@tlvmc.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Life (QoL) (time frame: All participants will be asked to fill the same questionnaires at the initiation of the study (T1) and again after 3 months (end of intervention)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Feb 2013.