Breast Cancer related pain is one of the

Breastcancer-related pain is one of the major complications that negatively impactthe patients’ quality of life. The conventional approach for pain management ismainly pharmaceutical. The prolonged use of these drugs, however, have majorside effects that lead to dose reduction or drug discontinuation in manyoccasions, resulting in inadequate pain relief.

Accordingly, there is anincreased need to incorporate other supportive approaches includingpsychological ones.  Cognitive Behavioral Therapy (CBT), a psychologicalintervention that works on modifying the dysfunctional thinking in patients,showed a statistically significant effect in reducing breast cancer-relatedpain. A strong evidence supports this result in western countries. However,there is no evidence supporting its effectiveness in relieving cancer-relatedpain in Saudi Arabia.

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This study aims to assess CBT effectiveness when combinedwith the conventional therapy for pain relief in breast cancer patients in thisregion. The subjects will be divided into two groups. The control group willreceive the standard pharmacological treatment only, while the interventiongroup will receive CBT in addition to the standard therapy for six months. Theseverity of pain will be assessed using Brief Pain Inventory (BPI) for allpatients both before and after the treatment, and the results will becompared.  a.

    Title: CBT effectiveness in reducing breastcancer-related pain in Saudi Arabiab.    Literature Review/Background and Significance: Cancer related pain is one of the most commonlyreported 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 treatmentincluding surgery, chemotherapy and radiotherapy. Pain has a negative impact onthe patients’ physical, emotional and cognitive functions, and consequently ontheir quality of life 2.The main approach in controlling cancer-related pain ispharmaceutical. The three-step approach proposed by WHO starts by theadministration of a nonopioid (aspirin and paracetamol); then mild opioid(codeine); then strong opioid if necessary.

Using this method, most of thepatients get their pain controlled 3. However, the long-term use of thesedrugs is associated with many side effects like constipation and respiratorydepression, which sometimes require decreasing the dose or even discontinuingthe opioid treatment that would eventually result in inadequate pain relief 4,5.Subsequently, the demand for using other approaches to control cancer-relatedpain is increasing. One of these approaches is cognitive behavioral therapy (CBT),which is adapted by manyphysicians to manage cancer related pain 6. A Meta-analysis study showed that lesspain is experienced by breast cancer patients who received CBT in comparison tothose who received the standard pharmacological therapy only 7. Consequently,the integration of pharmaceutical and psychological interventions is essentialin the management of cancer-related pain 8.Dysfunctional thinking is common to allpsychological diseases, so helping the patients to change their view to thingsin life and reevaluate their ideas will improve their emotional state andbehaviors.

Based on that, Beck’s invented a new therapy known as cognitivebehavioral therapy (CBT) which incorporates techniques from differentpsychotherapies such as problem solving therapy and acceptanceand commitment therapy. CBT is based on understanding the patients’specific beliefs and behaviors, working on the deeperlevel of cognition and modifying the dysfunctional thinking which helpsin treating the patients. This treatment was first directed to treatdepression; however, it is now used in different health settings weatherpsychological, psychiatric or other medical problems with psychologicalcomponents including cancer pain 9.

 Some of the CBT techniques used in managingpain related cancer are relaxation training, hypnosis, distraction and problemsolving 6.CBT is well known to be aneffective psychological intervention in western countries. However, limitedevidence support its effectiveness in other cultures 10.

Up to our knowledge,there is no previous studies on the effectiveness of CBT in reducingcancer-related pain in Saudi Arabia. This study will be the first evidencegenerated in Saudi Arabia that prove the effectiveness of CBT in reducing cancer-related pain among Saudi population. We expect that adding CBTto the conventional pain relief therapy in cancer patients will result in a significantimprovement in the patients’ quality of life.c.    Main objective(s): To assess the effectiveness of cognitivebehavioral therapy, used along with the standard pharmacological treatment for pain, in reducingbreast 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 populationThis non-blinded randomized clinicaltrial study will be conducted in King Faisal Specialized Hospital (KFSH), KingFahad Medical City (KFMC), Prince Sultan Military Medical City (PSMMC), Riyadh,Saudi Arabia. All female patients diagnosed with breast cancer between theperiod of January 2017 and December 2017 who are receiving the standardtreatment (chemotherapy, radiotherapy, surgery, etc.) for breast cancer, andexperiencing 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 tooldeveloped by the Pain Research Group of the WHO Collaborating Centre forSymptom Evaluation in Cancer Care. BPI measures both the severity of pain andits effect on the patients’ quality of life.

BPI is a powerful tool for painassessment that was proven to be both valid and reliable across differentcultures and languages 11. The Arabic version of BPI, was evaluated in aLebanese 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 inclusioncriteria before and after the intervention. ·      Cognitive behavioraltherapy (CBT):Cognitivebehavioral therapy (CBT) will be provided for the intervention group as an adjunctivetherapy along with the standard pharmacological pain relief treatment. CBT therapists will provide the CBT sessions forthe intervention group for a period of six months.  3.    Sample sizeWewill consult a statistician   4.

    Data management and analysisAfter weconsult a statistician, the appropriate data analysis tools will be used tocompare the BPI results for both the control and the intervention groups beforeand after the study to assess the degree of pain relief. In addition, thedegree of pain relief will be compared between the two groups to assess theeffectiveness of CBT intervention. 5.    Inclusion and exclusion criteria Tobe included in the study, the subject has to be:  a)     female b)    older than 18 yearsc)     having primary breast cancer d)    diagnosed between January 2017 and December 2017e)     currently receiving cancer treatment (chemotherapy, radiotherapy, surgery,etc.) for breast cancerf)     suffering from cancer related pain g)    understand Arabic Language and from Arabic origin.

Patientswho fail to fulfill any of the inclusion criteria will be excluded. Inaddition, any patient who matches any of the following statements will beexcluded.a)     Suffering from a sever medical conditions related to the musculoskeletalsystem like arthritis, which might result in severe pain that is unrelated tocancer. b)    Using over-the-counter medications to relief the pain.                                            ii.     Ethical ConsiderationTheIRB approval will be obtained before the conduction of the study. Theinformed consent of all patients willing to participate in the study will betaken. All patients have the right to withdraw from the study at any pointwithout any penalty.

Alldata collected will be protected and will remain confidential.