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

Sponsor

University Malaysia Sarawak (Other)

Overall Status

Completed

CT.gov ID

NCT05910541

Collaborator

University of Malaya (Other)

Enrollment

Location

Arms

2.9

Actual Duration (Months)

27.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Advanced Cancer	Behavioral: Mindful breathing Other: Standard care (control)	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Jan 2, 2020

Actual Primary Completion Date :

Mar 31, 2020

Actual Study Completion Date :

Mar 31, 2020

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Total score of ESAS [30 muinutes]
Assessment of efficacy of multisession 30 minutes mindful breathing on the total score of ESAS

Secondary Outcome Measures

Individual score of the ten symptoms in ESAS [30 minutes]
Assessment of efficacy of the multisession 30 minutes mindful breathing on the individual score of the 10 symptoms in ESAS.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Malaya Medical Centre	Kuala Lumpur		Malaysia	50603

Sponsors and Collaborators

University Malaysia Sarawak
University of Malaya

Investigators

Principal Investigator: Diana Leh Ching Ng, MD, University Malaysia Sarawak

Study Documents (Full-Text)

None provided.

More Information

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.

Responsible Party:

University Malaysia Sarawak

ClinicalTrials.gov Identifier:

NCT05910541

Other Study ID Numbers:

MREC No. 20191125-8042

First Posted:

Jun 18, 2023

Last Update Posted:

Jun 18, 2023

Last Verified:

Jun 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by University Malaysia Sarawak

mindful breathing, multisession, advanced cancers

Additional relevant MeSH terms:

Neoplasms

Respiratory Aspiration

Study Results

No Results Posted as of Jun 18, 2023