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

Not Applicable

Completed

• Conditions: Advanced Cancer
• Interventions: Behavioral: Mindful breathing; Other: Standard care (control)

• Registration Number: NCT05910541
• Lead Sponsor: University Malaysia Sarawak

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.

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 Timeline

• Study Start: 2020-01-02
• Primary Completion: 2020-03-31
• Study Completion: 2020-03-31
• Status Verified: 2023-06
• Study First Submitted: 2023-06-09
• Study First Submitted QC: 2023-06-09
• Last Update Submitted: 2023-06-09
• Study First Posted: 2023-06-18
• Last Update Posted: 2023-06-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Mindful breathing	Patients will receive standard care plus daily sessions of 30-minute mindful breathing for four consecutive days
Intervention	Standard care (control)	Patients will receive standard care plus daily sessions of 30-minute mindful breathing for four consecutive days
Control	Standard care (control)	Patients will only receive standard care.

Primary Outcome Measures

Name	Time	Method
Total score of ESAS	30 muinutes	Assessment of efficacy of multisession 30 minutes mindful breathing on the total score of ESAS

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

University Malaya Medical Centre; 🇲🇾 Kuala Lumpur, Malaysia