Cancer Clinical Trial
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.
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).
n/a
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
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