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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Advanced Cancer

Intervention / Treatment
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* Behavioral: Mindful breathing
* Other: Standard care (control)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mindful breathing, multisession, advanced cancers