The Efficacy of Multisession Mindful Breathing in Symptom Reduction Among Patients With Advanced Cancers
Primary Purpose
Advanced Cancer
Status
Completed
Phase
Not Applicable
Locations
Malaysia
Study Type
Interventional
Intervention
Mindful breathing
Standard care (control)
Sponsored by
About this trial
This is an interventional supportive care trial for Advanced Cancer focused on measuring mindful breathing, multisession, advanced cancers
Eligibility Criteria
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
Sites / Locations
- University Malaya Medical Centre
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Intervention
Control
Arm Description
Patients will receive standard care plus daily sessions of 30-minute mindful breathing for four consecutive days
Patients will only receive standard care.
Outcomes
Primary Outcome Measures
Total score of ESAS
Assessment of efficacy of multisession 30 minutes mindful breathing on the total score of ESAS
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT05910541
First Posted
June 9, 2023
Last Updated
June 9, 2023
Sponsor
University Malaysia Sarawak
Collaborators
University of Malaya
1. Study Identification
Unique Protocol Identification Number
NCT05910541
Brief Title
The Efficacy of Multisession Mindful Breathing in Symptom Reduction Among Patients With Advanced Cancers
Official Title
The Efficacy of Multisession Mindful Breathing in Symptom Reduction Among Patients: A Randomised Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
January 2, 2020 (Actual)
Primary Completion Date
March 31, 2020 (Actual)
Study Completion Date
March 31, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Malaysia Sarawak
Collaborators
University of Malaya
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Cancer
Keywords
mindful breathing, multisession, advanced cancers
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Patients will receive standard care plus daily sessions of 30-minute mindful breathing for four consecutive days
Arm Title
Control
Arm Type
Sham Comparator
Arm Description
Patients will only receive standard care.
Intervention Type
Behavioral
Intervention Name(s)
Mindful breathing
Intervention Description
30 minutes of mindful breathing session for 4 consecutive days, guided by investigators in addition to standard care.
Intervention Type
Other
Intervention Name(s)
Standard care (control)
Intervention Description
Standard care such as pain control, oxygen supplement.
Primary Outcome Measure Information:
Title
Total score of ESAS
Description
Assessment of efficacy of multisession 30 minutes mindful breathing on the total score of ESAS
Time Frame
30 muinutes
Secondary Outcome Measure Information:
Title
Individual score of the ten symptoms in ESAS
Description
Assessment of efficacy of the multisession 30 minutes mindful breathing on the individual score of the 10 symptoms in ESAS.
Time Frame
30 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Diana Leh Ching Ng, MD
Organizational Affiliation
University Malaysia Sarawak
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Malaya Medical Centre
City
Kuala Lumpur
ZIP/Postal Code
50603
Country
Malaysia
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
10813730
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.
Results Reference
background
PubMed Identifier
1714502
Citation
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.
Results Reference
result
Learn more about this trial
The Efficacy of Multisession Mindful Breathing in Symptom Reduction Among Patients With Advanced Cancers
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