The Efficacy of Multisession Mindful Breathing in Symptom Reduction Among Patients With Advanced Cancers

NCT05910541 | Completed

• 1 other identifier: MREC No. 20191125-8042
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to determine the efficacy of multisession mindful breathing in reducing symptoms among patients with advanced cancer. Adult patients with advanced cancer will be assessed using Edmonton Symptom Assessment System (ESAS) scoring system. Patients who scored ≥4 in at least two or more components in ESAS will be recruited and randomly assigned to either 4 daily-session of 30-minute mindful breathing and standard care or standard care alone.

Conditions

Advanced Cancer

Keywords

mindful breathing, multisession, advanced cancers

Outcome Measures

Primary Outcomes (1)

• Total score of ESAS

  Assessment of efficacy of multisession 30 minutes mindful breathing on the total score of ESAS

  30 muinutes

Secondary Outcomes (1)

• Individual score of the ten symptoms in ESAS

  30 minutes

Study Arms (2)

Intervention

EXPERIMENTAL

Patients will receive standard care plus daily sessions of 30-minute mindful breathing for four consecutive days

Behavioral: Mindful breathing; Other: Standard care (control)

Control

SHAM COMPARATOR

Patients will only receive standard care.

Other: Standard care (control)

Interventions

Mindful breathing BEHAVIORAL

30 minutes of mindful breathing session for 4 consecutive days, guided by investigators in addition to standard care.

Intervention

Standard care (control) OTHER

Standard care such as pain control, oxygen supplement.

Control; Intervention

Eligibility Criteria

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

You may qualify if:

• ongoing stage IIII-IV cancer, and a score of four or more in at least two components

You may not qualify if:

• impaired cognition or conscious level, as well as psychiatric illnesses that prevent them from giving informed consent or participating fully in the study

Sponsors & Collaborators

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

Study Sites (1)

University Malaya Medical Centre

Kuala Lumpur, 50603, Malaysia

Location

Related Publications (3)

• Chang VT, Hwang SS, Feuerman M. Validation of the Edmonton Symptom Assessment Scale. Cancer. 2000 May 1;88(9):2164-71. doi: 10.1002/(sici)1097-0142(20000501)88:93.0.co;2-5.

  PMID: 10813730 BACKGROUND

• Bruera E, Kuehn N, Miller MJ, Selmser P, Macmillan K. The Edmonton Symptom Assessment System (ESAS): a simple method for the assessment of palliative care patients. J Palliat Care. 1991 Summer;7(2):6-9.

  PMID: 1714502 RESULT

• Tung YZ, Ng DLC, Lai NZ, Ang CM, Lim PK, Zainuddin SI, Lam CL, Loh EC, Chai CS, Tan SB. Symptom reduction in advanced cancer from multi-session mindful breathing: randomised controlled study. BMJ Support Palliat Care. 2025 Feb 18:spcare-2024-005086. doi: 10.1136/spcare-2024-005086. Online ahead of print.

  PMID: 39965903 DERIVED

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Diana Leh Ching Ng, MD

  University Malaysia Sarawak

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: June 9, 2023
• First Posted: June 18, 2023
• Study Start: January 2, 2020
• Primary Completion: March 31, 2020
• Study Completion: March 31, 2020
• Last Updated: June 18, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)