Advanced CancerNCT05910541
The Efficacy of Multisession Mindful Breathing in Symptom Reduction Among Patients With Advanced Cancers
A study testing Mindful breathing in people with Advanced Cancer, run by University Malaysia Sarawak at 1 site in Malaysia.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Cancer
- What is being tested?
- Mindful breathing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteMalaysia
- Study dates
- 2 Jan 2020to 31 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ongoing stage IIII-IV cancer, and a score of four or more in at least two components
Who cannot join
- impaired cognition or conscious level, as well as psychiatric illnesses that prevent them from giving informed consent or participating fully in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Efficacy of Multisession Mindful Breathing in Symptom Reduction Among Patients: A Randomised Controlled Trial
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.
Read the 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.
- Conditions
- Advanced Cancer
- Being tested
- Mindful breathing, Standard care (control)
- Keywords
- mindful breathing, multisession, advanced cancers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindful breathingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Patients will receive standard care plus daily sessions of 30-minute mindful breathing for four consecutive days Receives: Behavioral: Mindful breathing; Other: Standard care (control) |
| Control | Sham comparator | Patients will only receive standard care. Receives: Other: Standard care (control) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total score of ESAS
Assessment of efficacy of multisession 30 minutes mindful breathing on the total score of ESAS
Measured: 30 muinutes
Secondary outcomes (1)
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.
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2023
- Study start2 Jan 2020
- Primary completion31 Mar 2020
- Study completion31 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Advanced CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Malaysia Sarawak
- Sponsor type
- University, hospital or other
- Collaborators
- University of Malaya
- Responsible party
- Sponsor
- Investigators
- Diana Leh Ching Ng, MD, Principal investigator, University Malaysia Sarawak
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05910541
- Sponsor's protocol ID
- MREC No. 20191125-8042
- Status last verified
- Jun 2023
- First submitted
- 9 Jun 2023
- Last updated
- 18 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 10813730Bruera 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.
PubMed 1714502Tung YZ, Ng DLC, Lai NZ, Ang CM, Lim PK, Zainuddin SI, Lam CL, Loh EC, Chai CS, Tan SB. Symptom reduction in advanced cancer from multi-session mindful breathing: randomised controlled study. BMJ Support Palliat Care. 2026 Apr 28;16(3):711-719. doi: 10.1136/spcare-2024-005086.
PubMed 39965903
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Multisession Mindful Breathing in Symptom Reduction Among Patients: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT05910541
- Acronym / sponsor ID
- MREC No. 20191125-8042
- Conditions
- Advanced Cancer
- Keywords
- mindful breathing, multisession, advanced cancers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University Malaysia SarawakUniversity, hospital or other
- Collaborators
- University of Malaya
- Study start
- 2 Jan 2020 (actual)
- Primary completion
- 31 Mar 2020 (actual)
- Study completion
- 31 Mar 2020 (actual)
- First posted
- 18 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Mindful breathing, Other: Standard care (control)Patients will receive standard care plus daily sessions of 30-minute mindful breathing for four consecutive days |
| Control | Sham comparator | Other: Standard care (control)Patients will only receive standard care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ongoing stage IIII-IV cancer, and a score of four or more in at least two components
Key exclusion criteria (1 listed)
- impaired cognition or conscious level, as well as psychiatric illnesses that prevent them from giving informed consent or participating fully in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindful breathing30 minutes of mindful breathing session for 4 consecutive days, guided by investigators in addition to standard care. | Behavioural | Intervention |
| Standard care (control)Standard care such as pain control, oxygen supplement. | Other | Control, Intervention |
Primary outcome
Total score of ESAS
Time frame: 30 muinutes
Assessment of efficacy of multisession 30 minutes mindful breathing on the total score of ESAS
1 secondary outcome
Individual score of the ten symptoms in ESAS
Time frame: 30 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2023.
- Background: PubMed 10813730Chang 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 publication: PubMed 1714502Bruera 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.
- Derived from this study: PubMed 39965903Tung YZ, Ng DLC, Lai NZ, Ang CM, Lim PK, Zainuddin SI, Lam CL, Loh EC, Chai CS, Tan SB. Symptom reduction in advanced cancer from multi-session mindful breathing: randomised controlled study. BMJ Support Palliat Care. 2026 Apr 28;16(3):711-719. doi: 10.1136/spcare-2024-005086.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Diana Leh Ching Ng, MD principal investigator
University Malaysia Sarawak
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindful breathing in people with Advanced Cancer, run by University Malaysia Sarawak at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total score of ESAS (time frame: 30 muinutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05910541, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2023.