Randomized Control Trial of Group Cognitive Behaviour Therapy in Reducing Postoperative Pain following Mastectomy among Malaysian women with breast cancer in General Hospital Kuala Lumpur

• Register: ANZCTR
• Last refreshed on: 4 July 2017
• Main ID: ACTRN12617000831381
• Date of registration: 06/06/2017
• Prospective Registration: No
• Primary sponsor: International Islamic University Malaysia
• Public title: Randomized Control Trial of Group Cognitive Behaviour Therapy in Reducing Postoperative Pain following Mastectomy among Malaysian women with breast cancer in General Hospital Kuala Lumpur
• Scientific title: Randomized Control Trial of Group Cognitive Behaviour Therapy in Reducing Postoperative Pain following Mastectomy in General Hospital Kuala Lumpur
• Date of first enrolment: 15/12/2015
• Target sample size: 100
• Recruitment status: Completed
• URL: http://www.anzctr.org.au/ACTRN12617000831381.aspx
• Study type: Interventional
• Study design: Randomised controlled trial Parallel
• Phase: Not Applicable

Health Condition(s) or Problem(s) studied

Breast cancer

Psychological distress

Undergoing mastectomy

Intervention(s)

The present study evaluated the efficacy of a psychological intervention, Group Cognitive Behaviour Therapy (CBT) in reducing postoperative pain among Malaysian breast cancer women in Hospital Kuala Lumpur. The patients who fulfilled all the criteria (refer to eligibility criteria) were offered to participate in the study. Once informed consent forms were received, patients were individually randomized into two groups. The first group referred to CBT with Treatment as Usual (TAU) while the second was the wait-list control with TAU.
The intervention applied the principles of CBT, which targeted to identify patients’ Automatic Thoughts (AT), emotional regulations and behavioural responses. This intervention followed the basics of psychological module which has been used in Cognitive Behaviour-Pain Management Program (CB-PMP) at Pain Clinic, in Selayang Hospital. In developing an intervention that tailored the needs of the target population in this study, a newer set of information was collated with more focus on psychological preparation towards mastectomy. The current intervention integrated a new of pertinent information which cover the biopsychosocial approach to facilitate main understanding about distress management and optimal recovery. The focus of the intervention was developed based upon the psychological components which were deemed important by the subject matter experts, namely, clinical psychologists, breast surgeons as well as patients/survivors. Prior to executing the study, some self-report measures along with interviews were held between researcher and experienced survivors who underwent similar surgical procedure. As a result, some inputs and feedback were then finalized to tailor the relevant needs in relation to psychological preparation for mastectomy. Some psychological component in CB-PMP were omitted (for example goal settings) as it did not reflect the needs for women with breast cancer for this study, and novel information (i.e psychoeducation on surgery side-effects, hand exercise) was integrated to the newly developed module. Through this process, which known as the triangulation method, attempts to gain a more meaningful understanding to create an impactful module. It is our assumption that the efforts to ensure an intervention is of useful, feasible and bears important theoretical context, would likely to produce positive outcomes in the study.
The intervention included simple homework for patients to bring home for several practices, for instance;1) usage of thought diary; 2) record down deep breathing activity in a schedule;3) practice hand exercise (as demonstrated in the sessions). The first and second sessions covered the introduction of breast cancer, biopsychosocial approach to facilitate understanding about the disease, psychoeducation on distress, postoperative pain, and fear over surgery, technique to combat AT using thought diary, and demonstration of relaxation strategy (deep breathing). The presentation was delivered using powerpoint file and hardcopy of notes and relevant leaflets were given in a file for each patient. The third session covered discussion on homework, and this slot attest the patients’ understanding and retention of knowledge in using the techniques. Also, the session was allocated for group discussion on any question on the skills or related matters. Finally, the last session was allocated for all important information about mastectomy, post-operative care, preparation for self-care during hospitalization and post-discharged, optimal recovery as well as exercise for hand care. In particular, the hand care included steps of hands, neck shoulder stretching and patients were able to practice together in a group for at least 20 minutes.
The delivery of intervention is by face-to-face sessions with the psychologist. The CBT was decided in a group, rather than individual sessions because patients expressed the importance of an opportunity to share their thoughts with persons with similar experiences. There were four sessions, each lasted 1 hour 15 minutes. The patients attended all four sessions within the two weeks before the surgery was performed,as it was the most feasible choice for them. While that, the other arm/group of the study is known as the control group with TAU. It refers to patients who received three standard pamphlets (given for CBT group), relaxation training of deep breathing and standard treatment of hospital procedures. There was approximately fifteen minutes of brief session with patients to share relaxation training, within a week before surgery. This control or wait-list group refers to those patients, with opportunity of receiving similar sessions as in treatment after the completion of this study.
The researcher had to observe the feasibility of holding the sessions to allow sufficient time for the intervention as well as getting mutual agreement with surgeons on setting the date for surgeries. Utmost importance is to en