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Trial registered on ANZCTR
Registration number
ACTRN12621001272886
Ethics application status
Approved
Date submitted
29/11/2020
Date registered
20/09/2021
Date last updated
20/09/2021
Date data sharing statement initially provided
20/09/2021
Date results information initially provided
20/09/2021
Type of registration
Retrospectively registered
Titles & IDs
Public title
The Effect of a Single Session of 30-Minute Mindful Breathing on Fatigue among Patients with Hematological Cancer – A Randomised Controlled Trial.
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Scientific title
The Effect of a Single Session of 30-Minute Mindful Breathing on Fatigue among Patients with Hematological Cancer – A Randomised Controlled Trial.
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Secondary ID [1]
302755
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Nil known
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Fatigue
319705
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haematological cancer
322340
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Condition category
Condition code
Cancer
317631
317631
0
0
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Leukaemia - Acute leukaemia
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Cancer
317632
317632
0
0
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Leukaemia - Chronic leukaemia
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Cancer
317633
317633
0
0
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Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
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Cancer
317634
317634
0
0
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Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
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Cancer
317635
317635
0
0
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Myeloma
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Cancer
317636
317636
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0
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Hodgkin's
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Patients with haematological cancer attending the haematological clinic or admitted to the
haematological ward of University of Malaya Medical Centre (UMMC), Kuala Lumpur, Malaysia were screened for eligibility, then subsequently randomised into intervention and control groups.
Patients allocated to the intervention group received standard care plus a single session (one-off) of guided 30-minute mindful breathing at their location of recruitment (clinic / ward). The mindful breathing session consisted of four breathing exercises done consecutively. The four exercises included identifying the in-and out-breath, following the entire length of the breath, bringing the mind back to the body and relaxing the whole body. Each exercise lasted for 7.5 minutes, therefore the total duration of the intervention was 30-minutes. The guidance was done by research assistants who are also medical doctors, face-to-face with individual patients. The research assistants were trained by one of the co-investigators who is a palliative care physician certified in mindfulness training.
The training included a 15-minute brief introduction to the basic concepts of mindfulness, followed by a 30-minute mindful breathing session guided by the trainer. Guidance on delivering the intervention with attention to paralanguage (intonation, rate and rhythm of speech, pitch, articulation, use of silence, etc.) and body language (eye contact, facial expression, posture and bodily movement), followed by supervision of the actual delivering of the 30-minute mindful breathing session by each research assistant were performed.
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Intervention code [1]
319039
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Treatment: Other
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Intervention code [2]
320855
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Behaviour
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Comparator / control treatment
Patients with haematological cancer attending the haematological clinic or admitted to the
haematological ward of University of Malaya Medical Centre (UMMC), Kuala Lumpur, Malaysia who were allocated to the control gorup received standard care alone. Standard care includes sleep or rests for fatigue, analgesics for pain, oxygen supplements for dyspnea, food for hunger, and continuation of other medications for haematological cancer. They were allowed to resume their usual activities for 30 minutes prior to further assessment.
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Control group
Active
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Outcomes
Primary outcome [1]
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Change in fatigue assessed using the Edmonton Symptom Assessment Scale (ESAS)
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Assessment method [1]
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Timepoint [1]
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30 minutes after mindful breathing intervention commencement
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Primary outcome [2]
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Change in fatigue assessed using the Functional Assessment of Chronic Illness Therapy Fatigue Scale (FACIT)
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Assessment method [2]
325680
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Timepoint [2]
325680
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30 minutes after mindful breathing intervention commencement
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Secondary outcome [1]
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The advantages of 30-minute mindful breathing using open-ended structural question - "Tell me about the positive aspects of this 30-minute mindful breathing?".
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Assessment method [1]
388749
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Timepoint [1]
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30 minutes after mindful breathing intervention commencement
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Secondary outcome [2]
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The disadvantages of 30-minute mindful breathing using open-ended structural question - "Tell me about the negative aspects of this 30-minute mindful breathing?".
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Assessment method [2]
396846
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Timepoint [2]
396846
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30 minutes after mindful breathing intervention commencement
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Secondary outcome [3]
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Patients' suggestion after undergo 30-minute mindful breathing using open-ended structural question - "Please suggest how to improve this 30-minute mindful breathing?".
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Assessment method [3]
396847
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Timepoint [3]
396847
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30 minutes after mindful breathing intervention commencement
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Secondary outcome [4]
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Patients' satisfaction of 30-minute mindful breathing using open-ended structural question - "Will you practice 30-minute mindful breathing in your daily life?".
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Assessment method [4]
396848
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Timepoint [4]
396848
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30 minutes after mindful breathing intervention commencement
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Eligibility
Key inclusion criteria
Patients aged 18 years and above, had a histopathological diagnosis of haematological cancer according to World Health Organisation classification, and a fatigue score of 4 or more based on the fatigue subscale of Edmonton Symptom Assessment System (ESAS).
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Patients with impaired conscious level, cognitive impairment or psychiatric illness that would prevent them from giving informed consent or participating fully in the study, current or history of cancer of other system, or a haemoglobin level less than 8g/dl.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelopes
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer-generated random numbers with blocks of 10, with a one-to-one allocation ratio.
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
The sample size was calculated based on the formula for a randomised control trial
for continuous variables with statistically superiority design, n = [2 SD 2 (Z a/2 + Z ß ) 2] divided by d2, in which n was sample size in each group; SD was standard deviation from a previous study; Z a/2 was the desired level of statistical significance, typically 1.96 for a type-1 error of 0.05; Z ß was the desired power, typically 0.842 for 80% power; d was the effect size, the difference in means. In this study, SD of 1.58 and d of 1 was taken. Therefore, the minimum sample size is 78 (39 for each arm).
Results for continuous variables were expressed as mean ± standard deviation (SD),
median or inter-quartile range depending on normality of the variable distributions; while
results for categorical variables were expressed as percentages. Between-groups differences for continuous data were compared by using independent sample t-test or Mann-Whitney U test, as applicable; while between-group differences for categorical data were compared by using Chi-Square test or Fisher-Exact test, as applicable. A 2-sided p-value of less than 0.05 was considered significant. Statistical analyses were performed using the software package, Statistical Package for the Social Sciences (SPSS for windows version 25.0, SPSS Inc, Chicago, IL, USA).
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
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Actual
1/10/2019
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Date of last participant enrolment
Anticipated
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Actual
31/05/2020
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Date of last data collection
Anticipated
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Actual
31/05/2020
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Sample size
Target
80
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Accrual to date
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Final
80
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Recruitment outside Australia
Country [1]
23098
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Malaysia
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State/province [1]
23098
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Kuala Lumpur
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Funding & Sponsors
Funding source category [1]
307176
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University
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Name [1]
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University of Malaysia Sarawak
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Address [1]
307176
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University Malaysia Sarawak (UNIMAS), Jalan Datuk Mohammad Musa, 94300 Kota Samarahan, Sarawak.
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Country [1]
307176
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Malaysia
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Primary sponsor type
Individual
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Name
Diana-Leh-Ching Ng
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Address
Department of Medicine, Faculty of Medicine and Health Science, University Malaysia Sarawak, Jalan Datuk Mohammad Musa, 94300 Kota Samarahan, Sarawak, Malaysia.
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Country
Malaysia
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Secondary sponsor category [1]
307775
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Individual
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Name [1]
307775
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Chee-Shee Chai
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Address [1]
307775
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Department of Medicine, Faculty of Medicine and Health Science, University Malaysia Sarawak, Jalan Datuk Mohammad Musa, 94300 Kota Samarahan, Sarawak, Malaysia.
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Country [1]
307775
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Malaysia
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Secondary sponsor category [2]
307776
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Individual
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Name [2]
307776
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Seng-Beng Tan
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Address [2]
307776
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Department of Medicine, Faculty of Medicine, University of Malaya, Jln Profesor Diraja Ungku Aziz, 50603 Kuala Lumpur, Wilayah Persekutuan Kuala Lumpur.
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Country [2]
307776
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Malaysia
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Secondary sponsor category [3]
307777
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Individual
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Name [3]
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Gin-Gin Gan
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Address [3]
307777
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Department of Medicine, Faculty of Medicine, University of Malaya, Jln Profesor Diraja Ungku Aziz, 50603 Kuala Lumpur, Wilayah Persekutuan Kuala Lumpur.
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Country [3]
307777
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Malaysia
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Other collaborator category [1]
281535
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Individual
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Name [1]
281535
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Nuradila Bt Anuar
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Address [1]
281535
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Department of Medicine, Faculty of Medicine, University of Malaya, Jln Profesor Diraja Ungku Aziz, 50603 Kuala Lumpur, Wilayah Persekutuan Kuala Lumpur.
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Country [1]
281535
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Malaysia
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Other collaborator category [2]
281536
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Individual
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Name [2]
281536
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Yu-Zhen Tung
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Address [2]
281536
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Department of Medicine, Faculty of Medicine, University of Malaya, Jln Profesor Diraja Ungku Aziz, 50603 Kuala Lumpur, Wilayah Persekutuan Kuala Lumpur.
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Country [2]
281536
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Malaysia
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Other collaborator category [3]
281537
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Individual
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Name [3]
281537
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Natalie-Zi Lai
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Address [3]
281537
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Department of Medicine, Faculty of Medicine, University of Malaya, Jln Profesor Diraja Ungku Aziz, 50603 Kuala Lumpur, Wilayah Persekutuan Kuala Lumpur.
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Country [3]
281537
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Malaysia
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Other collaborator category [4]
281538
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Individual
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Name [4]
281538
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Yi-Wen Tan
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Address [4]
281538
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Department of Medicine, Faculty of Medicine, University of Malaya, Jln Profesor Diraja Ungku Aziz, 50603 Kuala Lumpur, Wilayah Persekutuan Kuala Lumpur.
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Country [4]
281538
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Malaysia
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Other collaborator category [5]
281539
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Individual
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Name [5]
281539
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Siti Norazilah Bt Mohd Said
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Address [5]
281539
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Faculty of Cognitive Sciences and Human Development, University Malaysia Sarawak, Jalan Datuk Mohammad Musa, 94300 Kota Samarahan, Sarawak, Malaysia.
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Country [5]
281539
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Malaysia
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Other collaborator category [6]
281540
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Individual
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Name [6]
281540
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Amalia Bt Madihie
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Address [6]
281540
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Faculty of Cognitive Sciences and Human Development, University Malaysia Sarawak, Jalan Datuk Mohammad Musa, 94300 Kota Samarahan, Sarawak, Malaysia.
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Country [6]
281540
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Malaysia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
307289
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University Malaya Medical Centre (UMMC) Medical Research Ethics Committee
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Ethics committee address [1]
307289
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Pusat Perubatan Universiti Malaya, Lembah Pantai, 59100, Kuala Lumpur, MALAYSIA
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Ethics committee country [1]
307289
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Malaysia
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Date submitted for ethics approval [1]
307289
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03/06/2019
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Approval date [1]
307289
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02/09/2019
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Ethics approval number [1]
307289
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201971-7588
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Summary
Brief summary
This study aims to determine if mindful breathing exercise help to reduce the fatigue symptom among patients with haematological cancer. This is a non-invasive interventional study that involves a group of patients practicing mindful breathing versus another group who continues on standard care.
Patients were interviewed on their demographics and clinical data. Their fatigue severity were determined using the Edmonton Symptom Assessment Scale (ESAS) fatigue component and Functional Assessment and of Chronic Illness Therapy (FACIT) Fatigue Scale Version 4.
Next, patients were either be selected to practice mindful breathing or continue on standard care for for 30 minutes. After 30 minutes, patients from both groups will be asked the same questionnaire on fatigue. Patients from mindful breathing group were asked additionally on satisfaction and willingness to practice the 30 minute mindful breathing in daily life.
We hypothesize that mindful breathing exercises significantly reduce fatigue symptoms among patients with hematological cancer compare to standard care.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
106702
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Dr Diana-Leh-Ching Ng
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Address
106702
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Department of Medicine, Faculty of Medicine and Health Science, University Malaysia Sarawak, Jalan Datuk Mohammad Musa, 94300 Kota Samarahan, Sarawak, Malaysia.
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Country
106702
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Malaysia
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Phone
106702
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+60 19 819 8265
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Fax
106702
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Email
106702
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[email protected]
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Contact person for public queries
Name
106703
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Dr Diana-Leh-Ching Ng
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Address
106703
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Department of Medicine, Faculty of Medicine and Health Science, University Malaysia Sarawak, Jalan Datuk Mohammad Musa, 94300 Kota Samarahan, Sarawak, Malaysia,
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Country
106703
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Malaysia
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Phone
106703
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+60 19 819 8265
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Fax
106703
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Email
106703
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[email protected]
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Contact person for scientific queries
Name
106704
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A/Prof Seng-Beng Tan
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Address
106704
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Department of Medicine, Faculty of Medicine, University of Malaya, Jln Profesor Diraja Ungku Aziz, 50603 Kuala Lumpur, Wilayah Persekutuan Kuala Lumpur.
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Country
106704
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Malaysia
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Phone
106704
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+60 12 326 3128
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Fax
106704
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Email
106704
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
For patient personal data protection purposes. Data are only accessible by research investigators.
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What supporting documents are/will be available?
No Supporting Document Provided
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
9700
Other
Instructions for 30-minute mindful breathing
380911-(Uploaded-11-11-2020-15-17-27)-Study-related document.docx
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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