Single Session of 30-Minute Mindful Breathing in Reducing Fatigue

NCT05029024 | Completed

• 1 other identifier: 201971-7588
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Fatigue; Hematologic Malignancy

Keywords

Haematological cancer; fatigue; mindful breathing; Edmonton Symptom Assessment System

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• General feedback

  30-minute

Study Arms (2)

Intervention group

ACTIVE COMPARATOR

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

Control group

PLACEBO COMPARATOR

Patients in the control group received standard care alone.

Other: control group

Interventions

30-minute mindful breathing OTHER

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.

Intervention group

control group OTHER

standard care alone

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Malaysia Sarawak: lead
• University of Malaya: collaborator

Study Sites (1)

Diana-Leh-Ching Ng

Kuala Lumpur, 50603, Malaysia

Location

Related Publications (1)

• 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.

  PMID: 34649555 DERIVED

MeSH Terms

Conditions

Fatigue; Hematologic Neoplasms

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Seng-Beng Tan, MBBS

  Consultant, University Malaya Medical Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Parallel-group, non-blinded, randomised control trial

Study Record Dates

• First Submitted: August 4, 2021
• First Posted: August 31, 2021
• Study Start: October 1, 2019
• Primary Completion: May 31, 2020
• Study Completion: May 31, 2020
• Last Updated: August 31, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)