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Trial registered on ANZCTR


Registration number
ACTRN12618001345279
Ethics application status
Approved
Date submitted
1/08/2018
Date registered
9/08/2018
Date last updated
9/08/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Improving quality of life, physical and psychological issue by using chemotherapy counselling among cancer patients in Malaysia.
Scientific title
Effect of chemotherapy counseling by pharmacists on quality of life, physical and psychological issue among cancer patients in government hospitals in Malaysia
Secondary ID [1] 295716 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer 309111 0
Condition category
Condition code
Cancer 307987 307987 0 0
Any cancer

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention group: The intervention group received chemotherapy counseling by the pharmacist-in-charge of this study based on the "Managing Patients on Chemotherapy' module during their baseline, 1st follow-up, 2nd follow-up and 3rd follow-up sessions (one session per 6-week cycle).The intervention was takes place at designated locations in the hospital and each session is designed to last 45min ±10 min. Chemotherapy counseling was done one-on-one by the pharmacist-in-charge for this study which was trained by a clinical psychologist before starting the actual study. The counselling sessions were delivered through interactive format. The psychological, self-esteem, physical and QOL of assessed at the end of each 6-week cycle of chemotherapy.
Intervention code [1] 302038 0
Behaviour
Intervention code [2] 302039 0
Rehabilitation
Comparator / control treatment
Control group: The control group received the treatment as usual (TAU), which in Malaysia, cancer patients receive basic information about chemotherapy and side effects of chemotherapy by pharmacists only during the first session of chemotherapy. The information given is also only based on the questions the patients ask. Respondents in the control group also received the educational module at the end of study.
Control group
Active

Outcomes
Primary outcome [1] 306962 0
Quality of life: Quality of life was measured by the 26-items of WHOQOL-BREF which measuring four constructs of QOL such as; physical health, social relationship, psychological health and environment. Likert Scale (1) “very poor” to (5) “very good”, with range score between 26 to 130 were used as response categories
Timepoint [1] 306962 0

The QOL assessed at baseline, weeks 4,8 (primary endpoint) and 12, 18 weeks post-enrollment
Primary outcome [2] 306963 0
Psychological aspect: It was assessed through the validated Malay version of Patient Health Questionnaire-9 (PHQ-9) and Generalized anxiety disorder-7 (GAD-7) questionnaires.
Timepoint [2] 306963 0
The psychological aspect assessed at baseline, weeks 4,8 (primary endpoint) and 12, 18 weeks post-enrollment
Secondary outcome [1] 350267 0
Physical effects of chemotherapy will be based on the National Cancer Institute Common Toxicity Criteria version 2.0 by the World Health Organization (WHO)
Timepoint [1] 350267 0
Physical effects assessed at 6, 12 and 18 weeks post-enrollment.

Eligibility
Key inclusion criteria
All cancer patients (stage 1-4) aged over 18 years old undergoing chemotherapy treatment at government hospitals with oncology facilities in Malaysia.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Patients undergoing the third cycle of chemotherapy onwards
• patients with diagnosed psychiatric disorders who are on treatment and follow-up
• patients with psychotic features
• patients with severe communication problems such as speech or hearing difficulties

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
numbered containers
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A multi-stage sampling method was used and the eligible participants were assigned randomly in control group and intervention groups by using randomization table from a statistic book.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis
1. The data was analyzed by using Statistical Package for Social Science (SPSS) package
version 19.0.
2. One-Way ANOVA was used to determine the differences in the means of continuous data between control and intervention groups. The chi-square test was used to determine the association for categorical data.
3.The Cochran’s Q test was used to assess the difference in proportion of anxiety and depression within intervention and control groups over the period of study

The sample size was determined by considering group difference of 20% by using the Rosner formula . In order to obtain 90% power at 95% confidence interval with considering a 20% attrition rate, 2140 cancer patients from all ten public hospitals in Peninsular Malaysia were chosen to participate in this study. A total of twenty patients refused to participate in this study because of change of place (hospital), no more interest, and not feeling well. Therefore, only 2120 cancer patients completed three times ongoing counselling (response rate 99.11%).

- Rosner B. 920110. Fundamentals of Biostatistics. 7th ed. California, Thomson

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/04/2016
Date of last participant enrolment
Anticipated
Actual
1/09/2016
Date of last data collection
Anticipated
Actual
31/01/2017
Sample size
Target
2140
Accrual to date
Final
2120
Recruitment outside Australia
Country [1] 10722 0
Malaysia
State/province [1] 10722 0
Peninsular Malaysia

Funding & Sponsors
Funding source category [1] 300305 0
University
Name [1] 300305 0
Universiti Putra Malaysia
Country [1] 300305 0
Malaysia
Primary sponsor type
University
Name
Universiti Putra Malaysia
Address
Universiti Putra Malaysia
43400, Serdang
Selangor Darul Ehsan, MALAYSIA
Country
Malaysia
Secondary sponsor category [1] 299738 0
None
Name [1] 299738 0
Address [1] 299738 0
Country [1] 299738 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301117 0
Medical Research Ethics Committee of the Faculty of Medicine and Health Sciences, UPM
Ethics committee address [1] 301117 0
Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, Lorong Asam Jawa 1, Selangor, 43400 Serdang, Malaysia
Ethics committee country [1] 301117 0
Malaysia
Date submitted for ethics approval [1] 301117 0
01/09/2015
Approval date [1] 301117 0
03/03/2016
Ethics approval number [1] 301117 0

Summary
Brief summary
A randomized control trial was conducted among 2120 cancer patients from April 2016 to January 2017 to implement and evaluate the outcomes of chemotherapy counselling based on the “Managing Patients on Chemotherapy” module on quality of life, psychological affect (anxiety, depression) and physical affect of cancer patients by pharmacists in ten selected government hospitals in Peninsular Malaysia. The multistage random sampling method was used for selecting participants. Cancer patients were randomly assigned to intervention and control groups. The intervention group received chemotherapy counseling by pharmacists based on the “Managing Patients on Chemotherapy” module. The outcomes were assessed at baseline, 6, 12, and 18 weeks after counseling. In the course of data analysis; independent sample t-test, chi-square and two-way repeated measures ANOVA were conducted.
Trial website
Trial related presentations / publications
1. Mohd-Sidik SH, Akhtari-Zavare M, Periasamy U, et al (2018). Effectiveness of chemotherapy counselling on self-esteem and psychological affects among cancer patients in Malaysia: Randomized controlled trial. Patient Educ Couns, 101:862-871.
Public notes

Contacts
Principal investigator
Name 85918 0
Prof Dr Sherina Mohd Sidik
Address 85918 0
Cancer Resource & Education Center, Universiti Putra Malaysia, 43400, Serdang, Selangor, Malaysia.
Country 85918 0
Malaysia
Phone 85918 0
0060389471011
Fax 85918 0
0060389472706
Email 85918 0
[email protected]
Contact person for public queries
Name 85919 0
Dr Sherina Mohd Sidik
Address 85919 0
Cancer Resource & Education Center, Universiti Putra Malaysia, 43400, Serdang, Selangor, Malaysia.
Country 85919 0
Malaysia
Phone 85919 0
0060389471011
Fax 85919 0
0060389472706
Email 85919 0
[email protected]
Contact person for scientific queries
Name 85920 0
.Dr Sherina Mohd Sidik
Address 85920 0
Cancer Resource & Education Center, Universiti Putra Malaysia, 43400, Serdang, Selangor, Malaysia.
Country 85920 0
Malaysia
Phone 85920 0
0060389471011
Fax 85920 0
0060389472706
Email 85920 0
[email protected]

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