Single Session of 30-Minute Mindful Breathing in Reducing Fatigue

The Effect of a Single Session of 30-Minute Mindful Breathing in Reducing Fatigue Among Patients With Haematological Cancer - A Randomised Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Fatigue; Hematologic Malignancy
• Intervention / Treatment: Other: 30-minute mindful breathing; Other: control group

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Malaysia
  • Kuala Lumpur, Malaysia, 50603
    • Diana-Leh-Ching Ng

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• aged 18 years and above
• had a histopathological diagnosis of haematological cancer according to World Health Organisation classification
• a fatigue score of ≥ 4 based on the fatigue subscale of Edmonton Symptom Assessment System

Exclusion Criteria:

• 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 systems
• a haemoglobin level of < 8g/dl

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Intervention group; 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. They were trained by one of the co-investigators, who was a palliative care physician, certified in mindfulness training.	Other: 30-minute mindful breathing; 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.
Placebo Comparator: Control group; Patients in the control group received standard care alone.	Other: control group; standard care alone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fatigue severity by Edmonton Symptom Assessment System	Fatigue severity according to the tiredness subscale of Edmonton Symptom Assessment System. The scale range 0 (no tiredness) to 10 (worst possible tiredness). The higher the value indicates the more tiredness/fatigue.	30-minute
Fatigue severity by unidimensional visual analogue scale	Fatigue severity according to the unidimensional visual analogue scale. The analogue scale range 0 - 10, the higher indicates the worst fatigue.	30-minute
Fatigue severity by Functional Assessment of Chronic Illness Therapy Fatigue Scale Version 4	Fatigue severity according to the the score of Functional Assessment of Chronic Illness Therapy Fatigue Scale Version 4. This Scale has 13 items, each item range from 0 (not at all) to 4 (very much). The total score range from 0 to 52, the higher indicates more fatigue.	30-minute

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
General feedback	General feedback was asses by using simple questionnaires designed by investigators. Patients were asked open ended questions about general feedback of the intervention, if the intervention was harmful, if patients were satisfied and willing to practise 30-minute mindful breathing in daily life.	30-minute

Collaborators and Investigators

• Sponsor: University Malaysia Sarawak
• Collaborators: University of Malaya
• Investigators: Study Chair: Seng-Beng Tan, MBBS, Consultant, University Malaya Medical Center

Publications and helpful links

General Publications

• Ng DL, Gan GG, Anuar NA, Tung YZ, Lai NZ, Tan YW, Said SNM, Madihie A, Chai CS, Tan SB. The effect of a single session of 30-min mindful breathing in reducing fatigue among patients with haematological cancer - a randomised controlled trial. BMC Palliat Care. 2021 Oct 15;20(1):160. doi: 10.1186/s12904-021-00855-7.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2019
• Primary Completion (Actual): May 31, 2020
• Study Completion (Actual): May 31, 2020

Study Registration Dates

• First Submitted: August 4, 2021
• First Submitted That Met QC Criteria: August 15, 2021
• First Posted (Actual): August 31, 2021

Study Record Updates

• Last Update Posted (Actual): August 31, 2021
• Last Update Submitted That Met QC Criteria: August 15, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: fatigue; Haematological cancer; mindful breathing; Edmonton Symptom Assessment System
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Neoplasms; Respiration Disorders; Neoplasms by Site; Hematologic Diseases; Fatigue; Hematologic Neoplasms; Respiratory Aspiration
• Other Study ID Numbers: 201971-7588

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No