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The Immediate Effect of Mindfulness-Based Supportive Therapy on Palliating Suffering in Palliative Care Cancer Patients

Primary Purpose

Cancer, Suffering

Status
Completed
Phase
Not Applicable
Locations
Malaysia
Study Type
Interventional
Intervention
30-minute Mindfulness-Based Supportive Therapy
30-minute supportive listening
Sponsored by
University Malaysia Sarawak
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Cancer focused on measuring mindfulness, supportive, cancer, suffering, palliative

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 (CAM)
  • Patients who are non-communicative verbally
  • Patients with psychiatric illness

Sites / Locations

  • University Malaya Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Intervention group

Control group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.
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).

Secondary Outcome Measures

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.
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.

Full Information

First Posted
August 10, 2021
Last Updated
August 10, 2021
Sponsor
University Malaysia Sarawak
Collaborators
University of Malaya
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1. Study Identification

Unique Protocol Identification Number
NCT05010239
Brief Title
The Immediate Effect of Mindfulness-Based Supportive Therapy on Palliating Suffering in Palliative Care Cancer Patients
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
August 1, 2020 (Actual)
Primary Completion Date
December 31, 2020 (Actual)
Study Completion Date
December 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 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer, Suffering
Keywords
mindfulness, supportive, cancer, suffering, palliative

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel group, single-blinded, randomized controlled trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
68 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
30-minute Mindfulness-Based Supportive Therapy
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
30-minute supportive listening
Intervention Description
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.
Primary Outcome Measure Information:
Title
Suffering measured using the Suffering Pictogram.
Description
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.
Time Frame
30-minute
Title
Psychological distress examined using the Hospital Anxiety and Depression Scale.
Description
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.
Time Frame
30-minute
Title
Quality of life assessed by the Functional Assessment of Chronic Illness Therapy.
Description
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.
Time Frame
30-minute
Title
Patient's perception of practitioner empathic engagement measured with the Jefferson Scale of Patient's Perceptions of Physician Empathy
Description
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).
Time Frame
30-minute
Secondary Outcome Measure Information:
Title
Perception of stress measured by Perceived Stress Scale
Description
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.
Time Frame
30-minute
Title
Mindfulness measured by Frieburg Mindfulness Inventory
Description
Frieburg Mindfulness Inventory has 14 items, from 1 (rarely) to 4 (always). The higher the total score, the higher the mindfulness.
Time Frame
30-minute

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 (CAM) Patients who are non-communicative verbally Patients with psychiatric illness
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chee-Shee Chai, MD
Organizational Affiliation
Faculty of Medicine and Health Science, University Malaysia Sarawak
Official's Role
Study Director
Facility Information:
Facility Name
University Malaya Medical Center
City
Kuala Lumpur
State/Province
Selangor
ZIP/Postal Code
50603
Country
Malaysia

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
The data can be requested from the primary investigators. The data cannot upload to the public repository due to restrictions from the ethics committee.

Learn more about this trial

The Immediate Effect of Mindfulness-Based Supportive Therapy on Palliating Suffering in Palliative Care Cancer Patients

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