CancerNCT05010239
The Immediate Effect of Mindfulness-Based Supportive Therapy on Palliating Suffering in Palliative Care Cancer Patients
A study testing 30-minute Mindfulness-Based Supportive Therapy and 30-minute supportive listening in people with Cancer and Suffering, run by University Malaysia Sarawak at 1 site in Malaysia.
Trial summary
The was a parallel group, single-blinded, randomized controlled trial comparing the effectiveness of 30-minute mindfulness-based supportive therapy versus supportive listening in reducing suffering among patients with cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- 30-minute Mindfulness-Based Supportive Therapy and 30-minute supportive listening
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 68 participants
- Where
- 1 siteMalaysia
- Study dates
- 1 Aug 2020to 31 Dec 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
- Stage III and IV cancer patients aged 18 years and above
- The overall suffering score of 4/10 and above based on The Suffering Pictogram
Who cannot join
- Patients who are confused based on The Confusion Assessment scoring (CAM)
- Patients who are non-communicative verbally
- Patients with psychiatric illness
Trial locations and contacts
1 site in 1 country.
Malaysia1 site
University Malaya Medical Center
Kuala Lumpur, Selangor, 50603
About this study
Official title: The Immediate Effect of Mindfulness-Based Supportive Therapy (MBST) vs Supportive Listening on Palliating Suffering in Palliative Care Cancer Patients: A Randomised Controlled Trial
The was a parallel group, single-blinded, randomized controlled trial comparing the effectiveness of 30-minute mindfulness-based supportive therapy versus supportive listening in reducing suffering among patients with cancer. This study was conducted in the University Malaya Medical Centre, from 1st august 2020 to 31 December 2020.
Read the detailed description
This study was conducted in the University Malaya Medical Centre. The study design was a parallel-group, single-blinded, randomized controlled trial. The trial will be registered at the Clinical Trials registry and was conducted in accordance to the Declaration of Helsinki. The investigators recruited patients by screening patients under the care of the palliative care team at University Malaya Medical Centre. Patients fulfilling the inclusion and exclusion criteria will be approached and included in the study if give informed consent to participate.
Inclusion criteria:
- Stage III and IV cancer patients aged 18 years and above
- The overall suffering score of 4/10 and above based on The Suffering Pictogram
Exclusion criteria:
- Patients who are confused based on The Confusion Assessment scoring
- Patients who are non-communicative verbally
- Patients with psychiatric illness
Patients who were eligible were informed about the nature of the study. The study was voluntary and patients could withdraw from the study at any time. Patients who were interested to participate was randomly allocated to either the intervention group (MBST) or the control group (supportive listening) based on computer generated random numbers. Allocation concealment will be performed using sealed envelopes.
Patients in the intervention group received a 30-minute MBST session by a palliative care physician trained in mindfulness practice. The MBST consisted of a session that involvesd interviewing patients with open-ended questions on suffering experiences. During the session, the practitioner practiced mindful breathing simultaneously while listening to patients. The practitioner acknowledged the distress of patients when it was appropriate, but without losing their attention on mindful breathing.
Patients in the control group received a 30-minute supportive listening session by a palliative care physician who has no experience in mindfulness practice. The session involves interviewing patients with the same open-ended questions on suffering experiences. The practitioner acknowledged the distress of patients when it was appropriate. Outcomes will be measured at baseline and at minute 30.
Primary outcomes (patients): Suffering was measured using the Suffering Pictogram. It is a brief and validated instrument used to measure the experience of suffering in palliative care. Patients were required to rate overall suffering at the centre of the pictogram with a numerical scale of 0 to 10 (0 = no suffering, 10 = worst possible suffering). The pictogram contains eight items rated on a Likert scale - discomfort, worry, fear, anger, sadness, hopelessness, difficulty in acceptance and emptiness. The total suffering score of the eight items ranged from 0 to 32, with higher score reflecting more suffering.
Psychological distress was examined using the Hospital Anxiety and Depression Scale (HADS). The HADS consisted of 14 items rated on a Likert scale yielding a score of total score (0-42), an anxiety score (0-21) and a depression score (0-21), with higher score reflecting higher distress.
Quality of life (QOL) was assessed by the Functional Assessment of Chronic Illness Therapy (FACIT-Sp). It contained 39 items (range from 0 to 4, with higher scores reflecting higher QOL) forming an overall total score and five subscales scores: physical, social, emotional, functional and spiritual.
Patient's perception of practitioner empathic engagement was measured with the Jefferson Scale of Patient's Perceptions of Physician Empathy. It was a 5-item instrument (range from 1 to 5, with higher scores reflecting a greater degree of physician's empathy).
Secondary outcomes (practitioners): Secondary outcomes were measured by the Perceived Stress Scale (PSS) and the Frieburg Mindfulness Inventory (FMI).
- Being tested
- 30-minute Mindfulness-Based Supportive Therapy, 30-minute supportive listening
- Keywords
- mindfulness, supportive, cancer, suffering, palliative
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
30-minute Mindfulness-Based Supportive TherapyOther
The MBST consists of a session that involves interviewing patients with open-ended questions on suffering experiences. During the session, the practitioner will practice mindful breathing simultaneously while listening to patients. The practitioner will acknowledge the distress of patients when it is appropriate, but without losing their attention on mindful breathing.
30-minute supportive listeningOther
Patients in the control group will receive a 30-minute supportive listening session by a palliative care physician who has no experience in mindfulness practice. The session involves interviewing patients with the same open-ended questions on suffering experiences. The practitioner will acknowledge the distress of patients when it is appropriate. Outcomes will be measured at baseline and at minute 30.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Active comparator | Patients in the intervention group will receive a 30-minute MBST session by a palliative care physician trained in mindfulness practice. The MBST consists of a session that involves interviewing patients with open-ended questions on suffering experiences. During the session, the practitioner will practice mindful breathing simultaneously while listening to patients. The practitioner will acknowledge the distress of patients when it is appropriate, but without losing their attention on mindful breathing. Outcomes will be measured at baseline and at minute 30. Receives: Other: 30-minute Mindfulness-Based Supportive Therapy |
| Control group | Placebo comparator | Patients in the control group will receive a 30-minute supportive listening session by a palliative care physician who has no experience in mindfulness practice. The session involves interviewing patients with the same open-ended questions on suffering experiences. The practitioner will acknowledge the distress of patients when it is appropriate. Outcomes will be measured at baseline and at minute 30. Receives: Other: 30-minute supportive listening |
What is being measured
The primary outcome is the main question the study is designed to answer.
Suffering measured using the Suffering Pictogram.
Suffering pictogram is in numerical scale of 0 to 10 (0 = no suffering, 10 = worst possible suffering). The pictogram contains eight items rated on a Likert scale - discomfort, worry, fear, anger, sadness, hopelessness, difficulty in acceptance and emptiness. The total suffering score of the eight items ranges from 0 to 32, with higher score reflecting more suffering.
Measured: 30-minute
Psychological distress examined using the Hospital Anxiety and Depression Scale.
Hospital Anxiety and Depression Scale consists of 14 items rated on a Likert scale yielding a score of total score (0-42), an anxiety score (0-21) and a depression score (0-21), with higher score reflecting higher distress.
Measured: 30-minute
Quality of life assessed by the Functional Assessment of Chronic Illness Therapy.
Functional Assessment of Chronic Illness Therapy, contains 39 items (range from 0 to 4, with higher scores reflecting higher quality of life) forming an overall total score and five subscales scores: physical, social, emotional, functional and spiritual.
Measured: 30-minute
Patient's perception of practitioner empathic engagement measured with the Jefferson Scale of Patient's Perceptions of Physician Empathy
Jefferson Scale of Patient's Perceptions of Physician Empathy is a 5-item instrument (range from 1 to 5, with higher scores reflecting a greater degree of physician's empathy).
Measured: 30-minute
Secondary outcomes (2)
Perception of stress measured by Perceived Stress Scale
Perceived Stress Scale has 10 items, each range 0 - never to 4 - very often. The total score is 40, with higher score indicates more perceive stress.
Measured: 30-minute
Mindfulness measured by Frieburg Mindfulness Inventory
Frieburg Mindfulness Inventory has 14 items, from 1 (rarely) to 4 (always). The higher the total score, the higher the mindfulness.
Measured: 30-minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2021
- Study start1 Aug 2020
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Model description
- Parallel group, single-blinded, randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Malaysia Sarawak
- Sponsor type
- University, hospital or other
- Collaborators
- University of Malaya
- Responsible party
- Sponsor
- Investigators
- Chee-Shee Chai, MD, Study director, Faculty of Medicine and Health Science, University Malaysia Sarawak
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05010239
- Sponsor's protocol ID
- 202089-8970
- Status last verified
- Aug 2021
- First submitted
- 10 Aug 2021
- Last updated
- 18 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data can be requested from the primary investigators. The data cannot upload to the public repository due to restrictions from the ethics committee.
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Immediate Effect of Mindfulness-Based Supportive Therapy (MBST) vs Supportive Listening on Palliating Suffering in Palliative Care Cancer Patients: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT05010239
- Acronym / sponsor ID
- 202089-8970
- Keywords
- mindfulness, supportive, cancer, suffering, palliative
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- University Malaysia SarawakUniversity, hospital or other
- Collaborators
- University of Malaya
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 18 Aug 2021 (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 was a parallel group, single-blinded, randomized controlled trial comparing the effectiveness of 30-minute mindfulness-based supportive therapy versus supportive listening in reducing suffering among patients with cancer. This study was conducted in the University Malaya Medical Centre, from 1st august 2020 to 31 December 2020.
Detailed description
This study was conducted in the University Malaya Medical Centre. The study design was a parallel-group, single-blinded, randomized controlled trial. The trial will be registered at the Clinical Trials registry and was conducted in accordance to the Declaration of Helsinki. The investigators recruited patients by screening patients under the care of the palliative care team at University Malaya Medical Centre. Patients fulfilling the inclusion and exclusion criteria will be approached and included in the study if give informed consent to participate.
Inclusion criteria:
- Stage III and IV cancer patients aged 18 years and above
- The overall suffering score of 4/10 and above based on The Suffering Pictogram
Exclusion criteria:
- Patients who are confused based on The Confusion Assessment scoring
- Patients who are non-communicative verbally
- Patients with psychiatric illness
Patients who were eligible were informed about the nature of the study. The study was voluntary and patients could withdraw from the study at any time. Patients who were interested to participate was randomly allocated to either the intervention group (MBST) or the control group (supportive listening) based on computer generated random numbers. Allocation concealment will be performed using sealed envelopes.
Patients in the intervention group received a 30-minute MBST session by a palliative care physician trained in mindfulness practice. The MBST consisted of a session that involvesd interviewing patients with open-ended questions on suffering experiences. During the session, the practitioner practiced mindful breathing simultaneously while listening to patients. The practitioner acknowledged the distress of patients when it was appropriate, but without losing their attention on mindful breathing.
Patients in the control group received a 30-minute supportive listening session by a palliative care physician who has no experience in mindfulness practice. The session involves interviewing patients with the same open-ended questions on suffering experiences. The practitioner acknowledged the distress of patients when it was appropriate. Outcomes will be measured at baseline and at minute 30.
Primary outcomes (patients): Suffering was measured using the Suffering Pictogram. It is a brief and validated instrument used to measure the experience of suffering in palliative care. Patients were required to rate overall suffering at the centre of the pictogram with a numerical scale of 0 to 10 (0 = no suffering, 10 = worst possible suffering). The pictogram contains eight items rated on a Likert scale - discomfort, worry, fear, anger, sadness, hopelessness, difficulty in acceptance and emptiness. The total suffering score of the eight items ranged from 0 to 32, with higher score reflecting more suffering.
Psychological distress was examined using the Hospital Anxiety and Depression Scale (HADS). The HADS consisted of 14 items rated on a Likert scale yielding a score of total score (0-42), an anxiety score (0-21) and a depression score (0-21), with higher score reflecting higher distress.
Quality of life (QOL) was assessed by the Functional Assessment of Chronic Illness Therapy (FACIT-Sp). It contained 39 items (range from 0 to 4, with higher scores reflecting higher QOL) forming an overall total score and five subscales scores: physical, social, emotional, functional and spiritual.
Patient's perception of practitioner empathic engagement was measured with the Jefferson Scale of Patient's Perceptions of Physician Empathy. It was a 5-item instrument (range from 1 to 5, with higher scores reflecting a greater degree of physician's empathy).
Secondary outcomes (practitioners): Secondary outcomes were measured by the Perceived Stress Scale (PSS) and the Frieburg Mindfulness Inventory (FMI).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Parallel group, single-blinded, randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Active comparator | Other: 30-minute Mindfulness-Based Supportive TherapyPatients in the intervention group will receive a 30-minute MBST session by a palliative care physician trained in mindfulness practice. The MBST consists of a session that involves interviewing patients with open-ended questions on suffering experiences. During the session, the practitioner will practice mindful breathing simultaneously while listening to patients. The practitioner will acknowledge the distress of patients when it is appropriate, but without losing their attention on mindful breathing. Outcomes will be measured at baseline and at minute 30. |
| Control group | Placebo comparator | Other: 30-minute supportive listeningPatients in the control group will receive a 30-minute supportive listening session by a palliative care physician who has no experience in mindfulness practice. The session involves interviewing patients with the same open-ended questions on suffering experiences. The practitioner will acknowledge the distress of patients when it is appropriate. Outcomes will be measured at baseline and at minute 30. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Stage III and IV cancer patients aged 18 years and above
- The overall suffering score of 4/10 and above based on The Suffering Pictogram
Key exclusion criteria (3 listed)
- Patients who are confused based on The Confusion Assessment scoring (CAM)
- Patients who are non-communicative verbally
- Patients with psychiatric illness
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 |
|---|---|---|
| 30-minute Mindfulness-Based Supportive TherapyThe MBST consists of a session that involves interviewing patients with open-ended questions on suffering experiences. During the session, the practitioner will practice mindful breathing simultaneously while listening to patients. The practitioner will acknowledge the distress of patients when it is appropriate, but without losing their attention on mindful breathing. | Other | Intervention group |
| 30-minute supportive listeningPatients in the control group will receive a 30-minute supportive listening session by a palliative care physician who has no experience in mindfulness practice. The session involves interviewing patients with the same open-ended questions on suffering experiences. The practitioner will acknowledge the distress of patients when it is appropriate. Outcomes will be measured at baseline and at minute 30. | Other | Control group |
Primary outcome
Suffering measured using the Suffering Pictogram.
Time frame: 30-minute
Suffering pictogram is in numerical scale of 0 to 10 (0 = no suffering, 10 = worst possible suffering). The pictogram contains eight items rated on a Likert scale - discomfort, worry, fear, anger, sadness, hopelessness, difficulty in acceptance and emptiness. The total suffering score of the eight items ranges from 0 to 32, with higher score reflecting more suffering.
Psychological distress examined using the Hospital Anxiety and Depression Scale.
Time frame: 30-minute
Hospital Anxiety and Depression Scale consists of 14 items rated on a Likert scale yielding a score of total score (0-42), an anxiety score (0-21) and a depression score (0-21), with higher score reflecting higher distress.
Quality of life assessed by the Functional Assessment of Chronic Illness Therapy.
Time frame: 30-minute
Functional Assessment of Chronic Illness Therapy, contains 39 items (range from 0 to 4, with higher scores reflecting higher quality of life) forming an overall total score and five subscales scores: physical, social, emotional, functional and spiritual.
Patient's perception of practitioner empathic engagement measured with the Jefferson Scale of Patient's Perceptions of Physician Empathy
Time frame: 30-minute
Jefferson Scale of Patient's Perceptions of Physician Empathy is a 5-item instrument (range from 1 to 5, with higher scores reflecting a greater degree of physician's empathy).
2 secondary outcomes
Perception of stress measured by Perceived Stress Scale
Time frame: 30-minute
Mindfulness measured by Frieburg Mindfulness Inventory
Time frame: 30-minute
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 Aug 2021.
- Individual participant dataSharing planned: No. The data can be requested from the primary investigators. The data cannot upload to the public repository due to restrictions from the ethics committee.
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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.
Chee-Shee Chai, MD study director
Faculty of Medicine and Health Science, 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 30-minute Mindfulness-Based Supportive Therapy and 30-minute supportive listening in people with Cancer and Suffering, 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 2 inclusion and 3 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 Aug 2021. 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?
Suffering measured using the Suffering Pictogram. (time frame: 30-minute). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Aug 2021; AzTrials last refreshed its copy on 2 Nov 2026.