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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 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.
Scientific title
The Effect of a Single Session of 30-Minute Mindful Breathing on Fatigue among Patients with Hematological Cancer – A Randomised Controlled Trial.
Secondary ID [1] 302755 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Fatigue 319705 0
haematological cancer 322340 0
Condition category
Condition code
Cancer 317631 317631 0 0
Leukaemia - Acute leukaemia
Cancer 317632 317632 0 0
Leukaemia - Chronic leukaemia
Cancer 317633 317633 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
Cancer 317634 317634 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 317635 317635 0 0
Myeloma
Cancer 317636 317636 0 0
Hodgkin's

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 319039 0
Treatment: Other
Intervention code [2] 320855 0
Behaviour
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.
Control group
Active

Outcomes
Primary outcome [1] 325679 0
Change in fatigue assessed using the Edmonton Symptom Assessment Scale (ESAS)
Timepoint [1] 325679 0
30 minutes after mindful breathing intervention commencement
Primary outcome [2] 325680 0
Change in fatigue assessed using the Functional Assessment of Chronic Illness Therapy Fatigue Scale (FACIT)
Timepoint [2] 325680 0
30 minutes after mindful breathing intervention commencement
Secondary outcome [1] 388749 0
The advantages of 30-minute mindful breathing using open-ended structural question - "Tell me about the positive aspects of this 30-minute mindful breathing?".
Timepoint [1] 388749 0
30 minutes after mindful breathing intervention commencement
Secondary outcome [2] 396846 0
The disadvantages of 30-minute mindful breathing using open-ended structural question - "Tell me about the negative aspects of this 30-minute mindful breathing?".
Timepoint [2] 396846 0
30 minutes after mindful breathing intervention commencement
Secondary outcome [3] 396847 0
Patients' suggestion after undergo 30-minute mindful breathing using open-ended structural question - "Please suggest how to improve this 30-minute mindful breathing?".
Timepoint [3] 396847 0
30 minutes after mindful breathing intervention commencement
Secondary outcome [4] 396848 0
Patients' satisfaction of 30-minute mindful breathing using open-ended structural question - "Will you practice 30-minute mindful breathing in your daily life?".
Timepoint [4] 396848 0
30 minutes after mindful breathing intervention commencement

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).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

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)
Sealed opaque envelopes
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.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
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).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/10/2019
Date of last participant enrolment
Anticipated
Actual
31/05/2020
Date of last data collection
Anticipated
Actual
31/05/2020
Sample size
Target
80
Accrual to date
Final
80
Recruitment outside Australia
Country [1] 23098 0
Malaysia
State/province [1] 23098 0
Kuala Lumpur

Funding & Sponsors
Funding source category [1] 307176 0
University
Name [1] 307176 0
University of Malaysia Sarawak
Country [1] 307176 0
Malaysia
Primary sponsor type
Individual
Name
Diana-Leh-Ching Ng
Address
Department of Medicine, Faculty of Medicine and Health Science, University Malaysia Sarawak, Jalan Datuk Mohammad Musa, 94300 Kota Samarahan, Sarawak, Malaysia.
Country
Malaysia
Secondary sponsor category [1] 307775 0
Individual
Name [1] 307775 0
Chee-Shee Chai
Address [1] 307775 0
Department of Medicine, Faculty of Medicine and Health Science, University Malaysia Sarawak, Jalan Datuk Mohammad Musa, 94300 Kota Samarahan, Sarawak, Malaysia.
Country [1] 307775 0
Malaysia
Secondary sponsor category [2] 307776 0
Individual
Name [2] 307776 0
Seng-Beng Tan
Address [2] 307776 0
Department of Medicine, Faculty of Medicine, University of Malaya, Jln Profesor Diraja Ungku Aziz, 50603 Kuala Lumpur, Wilayah Persekutuan Kuala Lumpur.
Country [2] 307776 0
Malaysia
Secondary sponsor category [3] 307777 0
Individual
Name [3] 307777 0
Gin-Gin Gan
Address [3] 307777 0
Department of Medicine, Faculty of Medicine, University of Malaya, Jln Profesor Diraja Ungku Aziz, 50603 Kuala Lumpur, Wilayah Persekutuan Kuala Lumpur.
Country [3] 307777 0
Malaysia
Other collaborator category [1] 281535 0
Individual
Name [1] 281535 0
Nuradila Bt Anuar
Address [1] 281535 0
Department of Medicine, Faculty of Medicine, University of Malaya, Jln Profesor Diraja Ungku Aziz, 50603 Kuala Lumpur, Wilayah Persekutuan Kuala Lumpur.
Country [1] 281535 0
Malaysia
Other collaborator category [2] 281536 0
Individual
Name [2] 281536 0
Yu-Zhen Tung
Address [2] 281536 0
Department of Medicine, Faculty of Medicine, University of Malaya, Jln Profesor Diraja Ungku Aziz, 50603 Kuala Lumpur, Wilayah Persekutuan Kuala Lumpur.
Country [2] 281536 0
Malaysia
Other collaborator category [3] 281537 0
Individual
Name [3] 281537 0
Natalie-Zi Lai
Address [3] 281537 0
Department of Medicine, Faculty of Medicine, University of Malaya, Jln Profesor Diraja Ungku Aziz, 50603 Kuala Lumpur, Wilayah Persekutuan Kuala Lumpur.
Country [3] 281537 0
Malaysia
Other collaborator category [4] 281538 0
Individual
Name [4] 281538 0
Yi-Wen Tan
Address [4] 281538 0
Department of Medicine, Faculty of Medicine, University of Malaya, Jln Profesor Diraja Ungku Aziz, 50603 Kuala Lumpur, Wilayah Persekutuan Kuala Lumpur.
Country [4] 281538 0
Malaysia
Other collaborator category [5] 281539 0
Individual
Name [5] 281539 0
Siti Norazilah Bt Mohd Said
Address [5] 281539 0
Faculty of Cognitive Sciences and Human Development, University Malaysia Sarawak, Jalan Datuk Mohammad Musa, 94300 Kota Samarahan, Sarawak, Malaysia.
Country [5] 281539 0
Malaysia
Other collaborator category [6] 281540 0
Individual
Name [6] 281540 0
Amalia Bt Madihie
Address [6] 281540 0
Faculty of Cognitive Sciences and Human Development, University Malaysia Sarawak, Jalan Datuk Mohammad Musa, 94300 Kota Samarahan, Sarawak, Malaysia.
Country [6] 281540 0
Malaysia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307289 0
University Malaya Medical Centre (UMMC) Medical Research Ethics Committee
Ethics committee address [1] 307289 0
Ethics committee country [1] 307289 0
Malaysia
Date submitted for ethics approval [1] 307289 0
03/06/2019
Approval date [1] 307289 0
02/09/2019
Ethics approval number [1] 307289 0
201971-7588

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

Contacts
Principal investigator
Name 106702 0
Dr Diana-Leh-Ching Ng
Address 106702 0
Department of Medicine, Faculty of Medicine and Health Science, University Malaysia Sarawak, Jalan Datuk Mohammad Musa, 94300 Kota Samarahan, Sarawak, Malaysia.
Country 106702 0
Malaysia
Phone 106702 0
+60 19 819 8265
Fax 106702 0
Email 106702 0
nlcdiana@unimas.my
Contact person for public queries
Name 106703 0
Diana-Leh-Ching Ng
Address 106703 0
Department of Medicine, Faculty of Medicine and Health Science, University Malaysia Sarawak, Jalan Datuk Mohammad Musa, 94300 Kota Samarahan, Sarawak, Malaysia,
Country 106703 0
Malaysia
Phone 106703 0
+60 19 819 8265
Fax 106703 0
Email 106703 0
nlcdiana@unimas.my
Contact person for scientific queries
Name 106704 0
Seng-Beng Tan
Address 106704 0
Department of Medicine, Faculty of Medicine, University of Malaya, Jln Profesor Diraja Ungku Aziz, 50603 Kuala Lumpur, Wilayah Persekutuan Kuala Lumpur.
Country 106704 0
Malaysia
Phone 106704 0
+60 12 326 3128
Fax 106704 0
Email 106704 0
pramudita_1@hotmail.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
For patient personal data protection purposes. Data are only accessible by research investigators.


What supporting documents are/will be available?




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.