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

Advanced Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05910541
• Other study ID #: MREC No. 20191125-8042
• Status: Completed
• Phase: N/A
• Start date: January 2, 2020
• Est. completion date: March 31, 2020

Study information

• Verified date: June 2023
• Source: University Malaysia Sarawak
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: March 31, 2020
• Est. primary completion date: March 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Advanced Cancer
• Neoplasms
• Respiratory Aspiration

Intervention

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.

Locations

Country	Name	City	State
Malaysia	University Malaya Medical Centre	Kuala Lumpur

Sponsors (2)

Lead Sponsor	Collaborator
University Malaysia Sarawak	University of Malaya

Country where clinical trial is conducted

Malaysia, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total score of ESAS	Assessment of efficacy of multisession 30 minutes mindful breathing on the total score of ESAS	30 muinutes
Secondary	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