Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05029024 |
| Other study ID # |
201971-7588 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
October 1, 2019 |
| Est. completion date |
May 31, 2020 |
Study information
| Verified date |
August 2021 |
| Source |
University Malaysia Sarawak |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Investigators conducted a parallel-group, non-blinded, randomised control trial at the
haemato-oncology unit of University Malaya Medical Centre, from 1st October 2019 to 31st May
2020. Patients included were ≥ 18 years, had histopathological diagnosis of haematological
cancer, and fatigue score of ≥ 4 based on the fatigue subscale of Edmonton Symptom Assessment
System (ESAS). Patients allocated to the intervention group received standard care plus a
guided 30-minute mindful breathing session, while those in control group received standard
care. The study outcomes include fatigue severity according to the fatigue subscale of ESAS,
visual analogue scale of 0 - 10, and Functional Assessment of Chronic Illness Therapy Fatigue
Scale Version 4, at minute 0 and minute 30.
Description:
Investigators conducted a parallel-group, non-blinded, randomised control trial at the
haemato-oncology unit of University Malaya Medical Centre (UMMC), a tertiary university
hospital with 1,617 beds in Kuala Lumpur, capital of Malaysia, from 1st October 2019 to 31st
May 2020. Patients included were aged 18 years and above, had a histopathological diagnosis
of haematological cancer according to World Health Organisation classification, and a fatigue
score of ≥ 4 based on the fatigue subscale of Edmonton Symptom Assessment System (ESAS).
Patients were excluded if had impaired conscious level, cognitive impairment or any
psychiatric illness that would prevent patients from giving informed consent or participate
fully in the study; active or past history of cancer of other system, or a haemoglobin level
of < 8g/dl.
Procedure:
Patients with haematological cancer attending the haematology clinic or admitted to the
haematology ward of UMMC were consecutively screened for eligibility. The demographic and
clinical data of the eligible patients, which include age, gender, ethnicity, religion,
occupation, education level, marital status, type of haematological cancer, current status of
cancer, types of cancer treatment, duration of cancer, blood parameters and other
co-morbidities were obtained from the hospital Electronic Medical Record System. Any missing
information was obtained by face-to-face interview with patients or relatives.
Patients who satisfied the inclusion criteria and agreed to participate in the study were
randomly assigned into 2 groups based on computer-generated random numbers, in blocks of 10,
with a one-to-one allocation ratio. Allocation sequence was concealed with sealed envelopes
to prevent selection bias. Patients allocated to the intervention group received standard
care plus a guided 30-minute mindful breathing session which consisted of four breathing
exercises done consecutively in one-to-one manner. 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 7.5 minutes. Guidance was given by
one of the two research assistants, who were medical doctors. The research assistants were
trained by one of the co-investigators, who was a palliative care physician, certified in
mindfulness training.
The training included a 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 delivery of the 30-minute
mindful breathing session by each research assistant were performed. The instructions for the
30-minute mindful breathing are presented in Table 1. Patients in the control group received
standard care alone. Patients were allowed to resume usual activities 30 minutes prior to
further assessment. Regardless of whether in intervention or control group, patients
recruited in out-patient clinic were in sitting position, while patients recruited in ward
were in lying position during the study.
The study outcomes were assessed at minute 0 (before intervention - T0) and minute 30 (after
intervention - T30). The outcomes at T0 and T30 include fatigue severity according to the
fatigue subscale of ESAS, a unidimensional visual analogue scale (VAS) of 0 - 10, and the
score of Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale Version 4, a
multidimensional fatigue scale. At the end of the study, patients in the intervention group
were asked about feedback, any harm, and asked if patients were satisfied and willing to
practise 30-minute mindful breathing in daily life.
The ESAS is a valid and reliable tool to assess nine common symptoms experienced by cancer
patients. The nine symptoms assessed include: pain, tiredness, nausea, depression, anxiety,
drowsiness, loss of appetite, wellbeing and shortness of breath. An additional blank scale is
given to assess each patient's 'other problems' as needed. The severity for each symptom upon
assessment has a rating from 0 to 10 on a numerical scale; with 0 indicating absence of the
symptom and 10 indicating the worst symptom severity. For this study, the tiredness subscale
was chosen to assess participants' fatigue severity.
The FACIT Fatigue Scale is a 13-item multidimensional assessment tool to measure individual's
fatigue level during their normal daily activities over the past 7 days.(32) It has high
internal validity (Cronbach's alpha = 0.96) and high test-retest reliability (ICC = 0.95).
Each participant's level of fatigue is rated on a five point Likert scale (0 = not at all
fatigued to 4 = very much fatigued). The total FACIT-fatigue score ranges from 0 to 52, with
a higher score reflecting more fatigue.
