Clinical trial NCT05010239: 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
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Suffering
Keywords: mindfulness
supportive
cancer
suffering
palliative
Lead sponsor: University Malaysia Sarawak
Sponsor class: OTHER
Collaborators: name: University of Malaya
First posted: 2021-08-18
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel group, single-blinded, randomized controlled trial
Primary purpose: SUPPORTIVE_CARE

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).

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

Primary outcomes:
measure: Suffering measured using the Suffering Pictogram.
timeFrame: 30-minute
measure: Psychological distress examined using the Hospital Anxiety and Depression Scale.
timeFrame: 30-minute
measure: Quality of life assessed by the Functional Assessment of Chronic Illness Therapy.
timeFrame: 30-minute
measure: Patient's perception of practitioner empathic engagement measured with the Jefferson Scale of Patient's Perceptions of Physician Empathy
timeFrame: 30-minute
Secondary outcomes:
measure: Perception of stress measured by Perceived Stress Scale
timeFrame: 30-minute
measure: Mindfulness measured by Frieburg Mindfulness Inventory
timeFrame: 30-minute
Other outcomes:
Locations:
city: Kuala Lumpur
country: Malaysia
facility: University Malaya Medical Center
state: Selangor
Study officials:
affiliation: Faculty of Medicine and Health Science, University Malaysia Sarawak
name: Chee-Shee Chai, MD
role: STUDY_DIRECTOR
References: