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

The Efficacy of Multisession Mindful Breathing in Symptom Reduction Among Patients: A Randomised Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Advanced Cancer
• Intervention / Treatment: Behavioral: Mindful breathing; Other: Standard care (control)

Detailed Description

Patients with advanced cancer admitted to the medical and surgical wards of UMMC were consecutively approached to screen for eligibility. The 30-minute mindful breathing of the intervention group was guided by similar investigators for four consecutive days. These investigators were medical doctors who had been trained by the primary investigators - a palliative care physician and a certified mindfulness trainer. Each session used different scripts and was conducted in the languages that were preferred by the patients (such as Malay, English, or Mandarin). Briefly, patients were primed with knowledge of the gist of each script before being instructed to relax their bodies, close their eyes, pay attention to their breathing, and follow the guidance given. If they noticed any distractions, they were told to redirect their attention back to their breathing. Patients in the control group only received standard care and were assessed at the same time of the day by similar investigators for four consecutive days. Patients were allowed to continue their usual activities during each session.

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

Contacts and Locations

Study Locations

• Malaysia
  • Kuala Lumpur, Malaysia, 50603
    • University Malaya Medical Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

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
Experimental: Intervention; Patients will receive standard care plus daily sessions of 30-minute mindful breathing for four consecutive days	Behavioral: Mindful breathing; 30 minutes of mindful breathing session for 4 consecutive days, guided by investigators in addition to standard care.; Other: Standard care (control); Standard care such as pain control, oxygen supplement.
Sham Comparator: Control; Patients will only receive standard care.	Other: Standard care (control); Standard care such as pain control, oxygen supplement.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total score of ESAS	Assessment of efficacy of multisession 30 minutes mindful breathing on the total score of ESAS	30 muinutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Individual score of the ten symptoms in ESAS	Assessment of efficacy of the multisession 30 minutes mindful breathing on the individual score of the 10 symptoms in ESAS.	30 minutes

Collaborators and Investigators

• Sponsor: University Malaysia Sarawak
• Collaborators: University of Malaya
• Investigators: Principal Investigator: Diana Leh Ching Ng, MD, University Malaysia Sarawak

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2020
• Primary Completion (Actual): March 31, 2020
• Study Completion (Actual): March 31, 2020

Study Registration Dates

• First Submitted: June 9, 2023
• First Submitted That Met QC Criteria: June 9, 2023
• First Posted (Estimated): June 19, 2023

Study Record Updates

• Last Update Posted (Estimated): June 19, 2023
• Last Update Submitted That Met QC Criteria: June 9, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: mindful breathing, multisession, advanced cancers
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Neoplasms; Respiratory Aspiration
• Other Study ID Numbers: MREC No. 20191125-8042

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