Breast Cancer related pain is one of the

Breast
cancer-related pain is one of the major complications that negatively impact
the patients’ quality of life. The conventional approach for pain management is
mainly pharmaceutical. The prolonged use of these drugs, however, have major
side effects that lead to dose reduction or drug discontinuation in many
occasions, resulting in inadequate pain relief. Accordingly, there is an
increased need to incorporate other supportive approaches including
psychological ones.  Cognitive Behavioral Therapy (CBT), a psychological
intervention that works on modifying the dysfunctional thinking in patients,
showed a statistically significant effect in reducing breast cancer-related
pain. A strong evidence supports this result in western countries. However,
there is no evidence supporting its effectiveness in relieving cancer-related
pain in Saudi Arabia. This study aims to assess CBT effectiveness when combined
with the conventional therapy for pain relief in breast cancer patients in this
region. The subjects will be divided into two groups. The control group will
receive the standard pharmacological treatment only, while the intervention
group will receive CBT in addition to the standard therapy for six months. The
severity of pain will be assessed using Brief Pain Inventory (BPI) for all
patients both before and after the treatment, and the results will be
compared. 

 

a.    
Title:

CBT effectiveness in reducing breast
cancer-related pain in Saudi Arabia

b.    
Literature Review/Background and Significance:

Cancer related pain is one of the most commonly
reported complications of the disease, with a prevalence reported in 20% to 50%
of patients 1. Pain can be caused by both cancer and cancer related treatment
including surgery, chemotherapy and radiotherapy. Pain has a negative impact on
the patients’ physical, emotional and cognitive functions, and consequently on
their quality of life 2.

The main approach in controlling cancer-related pain is
pharmaceutical. The three-step approach proposed by WHO starts by the
administration of a nonopioid (aspirin and paracetamol); then mild opioid
(codeine); then strong opioid if necessary. Using this method, most of the
patients get their pain controlled 3. However, the long-term use of these
drugs is associated with many side effects like constipation and respiratory
depression, which sometimes require decreasing the dose or even discontinuing
the opioid treatment that would eventually result in inadequate pain relief 4,5.
Subsequently, the demand for using other approaches to control cancer-related
pain is increasing. One of these approaches is cognitive behavioral therapy (CBT),
which is adapted by many
physicians to manage cancer related pain 6. A Meta-analysis study showed that less
pain is experienced by breast cancer patients who received CBT in comparison to
those who received the standard pharmacological therapy only 7. Consequently,
the integration of pharmaceutical and psychological interventions is essential
in the management of cancer-related pain 8.

Dysfunctional thinking is common to all
psychological diseases, so helping the patients to change their view to things
in life and reevaluate their ideas will improve their emotional state and
behaviors. Based on that, Beck’s invented a new therapy known as cognitive
behavioral therapy (CBT) which incorporates techniques from different
psychotherapies such as problem solving therapy and acceptance
and commitment therapy. CBT is based on understanding the patients’
specific beliefs and behaviors, working on the deeper
level of cognition and modifying the dysfunctional thinking which helps
in treating the patients. This treatment was first directed to treat
depression; however, it is now used in different health settings weather
psychological, psychiatric or other medical problems with psychological
components including cancer pain 9.  Some of the CBT techniques used in managing
pain related cancer are relaxation training, hypnosis, distraction and problem
solving 6.

CBT is well known to be an
effective psychological intervention in western countries. However, limited
evidence support its effectiveness in other cultures 10. Up to our knowledge,
there is no previous studies on the effectiveness of CBT in reducing
cancer-related pain in Saudi Arabia. This study will be the first evidence
generated in Saudi Arabia that prove the effectiveness of CBT in reducing cancer-related pain among Saudi population. We expect that adding CBT
to the conventional pain relief therapy in cancer patients will result in a significant
improvement in the patients’ quality of life.

c.    
Main objective(s):

To assess the effectiveness of cognitive
behavioral therapy, used along with the standard pharmacological treatment for pain, in reducing
breast cancer- related pain in comparison to the use of the standard treatment alone
(Aspirin, paracetamol and opioid).

d.    
Methods Section:

                                              
i.     Study design

1.    
Defining patient population

This non-blinded randomized clinical
trial study will be conducted in King Faisal Specialized Hospital (KFSH), King
Fahad Medical City (KFMC), Prince Sultan Military Medical City (PSMMC), Riyadh,
Saudi Arabia. All female patients diagnosed with breast cancer between the
period of January 2017 and December 2017 who are receiving the standard
treatment (chemotherapy, radiotherapy, surgery, etc.) for breast cancer, and
experiencing pain related to their cancer, represent the study population.

2.    
Instruments to be used (if any)

·     
Brief Pain Inventory (BPI):

Brief Pain Inventory (BPI) is a pain assessment tool
developed by the Pain Research Group of the WHO Collaborating Centre for
Symptom Evaluation in Cancer Care. BPI measures both the severity of pain and
its effect on the patients’ quality of life. BPI is a powerful tool for pain
assessment that was proven to be both valid and reliable across different
cultures and languages 11. The Arabic version of BPI, was evaluated in a
Lebanese sample of cancer patients, and the findings support its reliability,
validity and cultural sensitivity in this population 12. Brief Pain Inventory
(BPI) will be used for pain assessment in all patients who met the inclusion
criteria before and after the intervention.

·      Cognitive behavioral
therapy (CBT):

Cognitive
behavioral therapy (CBT) will be provided for the intervention group as an adjunctive
therapy along with the standard pharmacological pain relief treatment. CBT therapists will provide the CBT sessions for
the intervention group for a period of six months. 

3.    
Sample size

We
will consult a statistician 

 

4.    
Data management and analysis

After we
consult a statistician, the appropriate data analysis tools will be used to
compare the BPI results for both the control and the intervention groups before
and after the study to assess the degree of pain relief. In addition, the
degree of pain relief will be compared between the two groups to assess the
effectiveness of CBT intervention.

 

5.    
Inclusion and exclusion criteria

To
be included in the study, the subject has to be: 

a)     female

b)    older than 18 years

c)     having primary breast cancer

d)    diagnosed between January 2017 and December 2017

e)     currently receiving cancer treatment (chemotherapy, radiotherapy, surgery,
etc.) for breast cancer

f)     suffering from cancer related pain

g)    understand Arabic Language and from Arabic origin.

Patients
who fail to fulfill any of the inclusion criteria will be excluded. In
addition, any patient who matches any of the following statements will be
excluded.

a)     Suffering from a sever medical conditions related to the musculoskeletal
system like arthritis, which might result in severe pain that is unrelated to
cancer.

b)    Using over-the-counter medications to relief the pain.

                                            
ii.     Ethical Consideration

The
IRB approval will be obtained before the conduction of the study.

The
informed consent of all patients willing to participate in the study will be
taken. All patients have the right to withdraw from the study at any point
without any penalty.

All
data collected will be protected and will remain confidential.