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Trial registered on ANZCTR


Registration number
ACTRN12617000831381
Ethics application status
Approved
Date submitted
3/04/2017
Date registered
6/06/2017
Date last updated
6/06/2017
Type of registration
Retrospectively registered

Titles & IDs
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
Secondary ID [1] 291609 0
Ministry of Health Medical Research Ethics Committee (MREC) NMRR-13-1762-17628
Universal Trial Number (UTN)
None
Trial acronym
None
Linked study record
None

Health condition
Health condition(s) or problem(s) studied:
Breast cancer 302728 0
Undergoing mastectomy 302854 0
Psychological distress 302855 0
Condition category
Condition code
Cancer 302247 302247 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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 ensure there would be no undesirable whatsoever consequences on patients’ treatment or health. The intervention was conducted by a clinical psychologist who had five years of experience, who is under supervision of an expert clinical psychologist in the area of cognitive behavior-chronic pain management (who possesses thirteen years of delivering cognitive behavioural pain management programme), and a consultant breast surgeon. There was a supervision on a monthly basis between clinical psychologist and the two professionals to update on the adherence of intervention. Any other matters related to the study were also discussed during supervision. The privacy and confidentiality of information of intervention were protected as the discussions were only for academic purpose. In addition, a clear set of housekeeping rules were also laid out for the respondents as well as research enumerators, matron, nurses and doctors who were involved in the study. The adherence to the sessions for the patients were kept in a log book with details of dates of appointments and follow-up sessions. There was also additional file where patients’ clinical observations were recorded, and used for reference in discussions for all research team members.
The sessions for intervention took place at the Health Education seminar room, the Specialist Complex and Ambulatory Care Centre, Level 6, Hospital Kuala Lumpur (SCACC, HKL) or the Anggerik room at the Surgical Ward 11, main building of HKL.
Intervention code [1] 297681 0
Treatment: Other
Comparator / control treatment
In meeting the ethics requirement set by the CRC Malaysia at the recruitment site, patients in control group were also given minimum information about relaxation strategy (deep breathing) and some pamphlets. These hardcopies were provided from CareUPM a Non-Government Organizations (NGO), under the Universiti Putra Malaysia (UPM). The pamphlets encompass brief information about breast cancer, physical activities, and simple diet guideline for breast cancer. Apart from receiving these information, these patients belong to the wait-list group where they received similar group sessions, after the completion of this study.
Control group
Active

Outcomes
Primary outcome [1] 301655 0
Postoperative pain score using the Numerical Rating Scale (NRS)
Timepoint [1] 301655 0
1- Baseline (Before the start of intervention)
2- During hospitalization (Post-operative time points- 3rd / 4th day of hospitalization)
3- Post-operative follow-up period (at 1st and 3rd month following surgery)
Secondary outcome [1] 333469 0
-Anxiety symptoms
Self-administered of Visual Analogue Scale: Emotion Thermometer (Mitchell, 2010)
Timepoint [1] 333469 0
1- Baseline (Before the start of intervention)
2- During hospitalization (Post-operative time points- 3rd / 4th day of hospitalization)
3- Post-operative follow-up period (at 1st and 3rd month following surgery)
Secondary outcome [2] 334392 0
-Pain Catastrophizing Scale (PCS)
Self-administered questionnaire: Pain Catastrophizing Scale (Sullivan, 2009)
Timepoint [2] 334392 0
1- Baseline (Before the start of intervention)
2- During hospitalization (Post-operative time points- 3rd / 4th day of hospitalization)
3- Post-operative follow-up period (at 1st and 3rd month following surgery)
Secondary outcome [3] 334393 0
-Fear of Surgery
Self-administered questionnaire: Surgical Fear Questionnaire (Theunissen, 2014 )
Timepoint [3] 334393 0
1- Baseline (Before the start of intervention)
2- During hospitalization (Post-operative time points- 3rd / 4th day of hospitalization)
3- Post-operative follow-up period (at 1st and 3rd month following surgery)
Secondary outcome [4] 334394 0
-Quality of Sleep
Self-administered of Visual Analogue: Leeds Sleep Evaluation Questionnaire (Hindmarch, 1980)
Timepoint [4] 334394 0
1- Baseline (Before the start of intervention)
2- During hospitalization (Post-operative time points- 3rd / 4th day of hospitalization)
3- Post-operative follow-up period (at 1st and 3rd month following surgery)
Secondary outcome [5] 335035 0
Depressive symptoms
Self-administered questionnaire: Patient Health Questionnaire (PHQ-9) by Sherina et. al (2012)
Timepoint [5] 335035 0
1- Baseline (Before the start of intervention)
2- During hospitalization (Post-operative time points- 3rd / 4th day of hospitalization)
3- Post-operative follow-up period (at 1st and 3rd month following surgery)

Eligibility
Key inclusion criteria
i) Female aged between 18 and 65
ii) Literate with good understanding of Malay or English
iii) Confirmed diagnosis of breast cancer (stage one through three with specific the tumor, node metastases system)
iv) Patients who fulfil the cut-off scores of Distress thermometer (score of 3 or above), and clinical discretion showing the person is in distress.
Minimum age
18 Years
Maximum age
65 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
i) Pregnant
ii) Previous repeat breast or axillary surgeries (I.e: wide excision or
axillary clearance) within three months before the disclosure of diagnosis
iii) Any complaint of axillary haematoma
iv) Detectable metastatic disease
v) History of neurological illness or being treated having psychiatric disorder
vi) Diabetic, if poor control.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
All patients’ clinical profiles and medical files were checked through to ensure they meet the eligibility criteria. Patients who met all the criteria and consented to join the study would then be randomized. The patient would either be allocated for Group CBT or treatment as usual (TAU). The surgeons encouraged all eligible patients to join the research without knowing the allocation. When the diagnosis was confirmed by the surgeons, the shortlisted patients were briefed with comprehensive information about the study by the principle researcher. An enumerator who is blinded from the research aims, facilitated in screening and interviewing patients who seek for assistance for the baseline measures. Otherwise, patients who understood the instructions filled in the self-report measures individually.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Those patients eligible and consented to participate the study were randomly allocated based on a list of numbers which were generated by a computer program. This task was executed in a systematic procedure by a trained enumerator who was not involved in the intervention or trial. The randomization list was prepared in advance, later put into envelopes and handed over to principle researcher. Those opaqued enveloped were ensured concealed and numbered so that the recruiter had to the next envelope.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
In sum, this study is a two-arm, single blind randomized control parallel trial with intervention and wait-list control group.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Descriptive tests and repeated measures analysis of variance.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
15/12/2015
Date of last participant enrolment
Anticipated
Actual
27/10/2016
Date of last data collection
Anticipated
Actual
14/02/2017
Sample size
Target
100
Accrual to date
Final
70
Recruitment outside Australia
Country [1] 8775 0
Malaysia
State/province [1] 8775 0
Kuala Lumpur only

Funding & Sponsors
Funding source category [1] 296098 0
University
Name [1] 296098 0
Universiti Putra Malaysia (Initiative Graduate Studies)
Country [1] 296098 0
Malaysia
Primary sponsor type
University
Name
International Islamic University Malaysia
Address
International Islamic University Malaysia
P.O Box 10
50728 Kuala Lumpur
Country
Malaysia
Secondary sponsor category [1] 294994 0
None
Name [1] 294994 0
None
Address [1] 294994 0
None
Country [1] 294994 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297355 0
Ministry of Health Medical Research Ethics Committee (MREC)
Ethics committee address [1] 297355 0
Ethics committee country [1] 297355 0
Malaysia
Date submitted for ethics approval [1] 297355 0
13/05/2015
Approval date [1] 297355 0
09/12/2015
Ethics approval number [1] 297355 0
NMRR-13-1762-17628

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 73790 0
Mrs Nur Haidzat bt Abd Wahid
Address 73790 0
Department of Psychology,
Kulliyyah of IRK Human Sciences
International Islamic University Malaysia
P.O Box 10 50728 Kuala Lumpur
Country 73790 0
Malaysia
Phone 73790 0
+603- 6196 5146
Fax 73790 0
+603 6196 5063
Email 73790 0
haidzatnur@yahoo.com.au
Contact person for public queries
Name 73791 0
Nur Haidzat bt Abd Wahid
Address 73791 0
Department of Psychology,
Kulliyyah of IRK Human Sciences
International Islamic University Malaysia
P.O Box 10 50728 Kuala Lumpur
Country 73791 0
Malaysia
Phone 73791 0
+603- 6196 5146
Fax 73791 0
none
Email 73791 0
haidzatnur@yahoo.com.au
Contact person for scientific queries
Name 73792 0
Nur Haidzat bt Abd Wahid
Address 73792 0
Department of Psychology,
Kulliyyah of IRK Human Sciences
International Islamic University Malaysia
P.O Box 10 50728 Kuala Lumpur
Country 73792 0
Malaysia
Phone 73792 0
+603- 6196 5146
Fax 73792 0
none
Email 73792 0
haidzatnur@yahoo.com.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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