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CompletedNCT05910541Updated Jun 18, 2023

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

An interventional study of Mindful breathing and Standard care (control) in Advanced Cancer, sponsored by University Malaysia Sarawak. Completed at 1 site in Malaysia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-06-18.

Sponsored by University Malaysia Sarawak · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 3 years 5 months after the study started (first participant enrolled Jan 2020, registered Jun 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Advanced Cancer

Keywords

  • mindful breathing, multisession, advanced cancers
03

In context

Neoplasms

9,359 studies on the registry are indexed under Neoplasms; 2,486 are open to participants now.

This study's enrollment of 80 is above the median of 50 across 7,250 interventional studies indexed under Neoplasms.

Browse Neoplasms studies →

Lead sponsor

University Malaysia Sarawak is the lead sponsor of 13 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
80 participants (actual)

Study arms

  • Experimental
    Intervention

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

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

  • Sham comparator
    Control

    Patients will only receive standard care.

    Other: Standard care (control)

Interventions

  • BehavioralMindful breathing

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

  • OtherStandard care (control)

    Standard care such as pain control, oxygen supplement.

06

What researchers measure

Primary outcomes

  1. Total score of ESAS

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

    Time frame: 30 muinutes

Secondary outcomes

  1. 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.

    Time frame: 30 minutes

07

Study locations

1 site
  • University Malaya Medical Centre
    Kuala Lumpur, 50603, Malaysia
08

References and documents

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. PubMed 10813730 ↗
  • 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. PubMed 1714502 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 18, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05910541
Lead sponsor
University Malaysia Sarawak
Collaborators
University of Malaya
Responsible party
Sponsor
First posted
Jun 18, 2023
Start date
Jan 2, 2020
Primary completion
Mar 31, 2020
Completion
Mar 31, 2020
Last update
Jun 18, 2023

Study contacts

Diana Leh Ching Ng, MD
principal investigator · University Malaysia Sarawak

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.

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