A Randomized Controlled Trial of Inquiry Based Stress Reduction (IBSR) Program for Cancer Survivors. (IBSR)

February 17, 2013 updated by: Tel-Aviv Sourasky Medical Center

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.

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

300

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion criteria:

  • Participants not speaking Hebrew;
  • Not able to give informed consent due to impaired mental or intellectual state
  • Advanced cancer stage
  • Current psychiatric diagnosis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Inquiry Based Stress Reduction (IBSR) Program
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.
Behavioral: Inquiry Based Stress Reduction (IBSR)
Other Names:
  • The Work meditation (Byron Katie)
No Intervention: Control group
Waited-list control

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
biological markers
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)
Level of cortisol, NK cells activity, T cells count,C-reactive protein
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tel-Aviv Sourasky Medical Center

Investigators

  • Principal Investigator: Nadir Arber, Prof., Tel Aviv Medical Center
  • Study Director: Shahar LevAri, PhD, Tel Aviv Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2013

Primary Completion (Anticipated)

June 1, 2016

Study Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

February 17, 2013

First Submitted That Met QC Criteria

February 17, 2013

First Posted (Estimate)

February 20, 2013

Study Record Updates

Last Update Posted (Estimate)

February 20, 2013

Last Update Submitted That Met QC Criteria

February 17, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • TASMC-13-NA-549-CTIL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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