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OpenTrials
Completed

NCT Number: NCT05910541

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

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Malaya Medical Centre

Kuala Lumpur, 50603, Malaysia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mindful Breathing

Behavioral

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

Standard care (control)

Other

Standard care such as pain control, oxygen supplement.

Primary outcomes

  1. Total score of ESAS

    Time frame: 30 muinutes

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

Secondary outcomes

  1. Individual score of the ten symptoms in ESAS

    Time frame: 30 minutes

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

Sponsors and collaborators

Lead sponsor

University Malaysia Sarawak

Other

Collaborators

  • University of Malaya

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jun 18, 2023
Registry last updated
Jun 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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