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

NCT ID: NCT05010239

Last Updated: 2021-08-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 68 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-01
• Study Completion Date: 2020-12-31

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).

Conditions

Cancer; Suffering

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Intervention group

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.

Group Type: ACTIVE_COMPARATOR

30-minute Mindfulness-Based Supportive Therapy

Intervention Type: OTHER

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.

Control group

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.

Group Type: PLACEBO_COMPARATOR

30-minute supportive listening

Intervention Type: OTHER

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.

Interventions

30-minute Mindfulness-Based Supportive Therapy

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

30-minute supportive listening

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

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Malaya

OTHER

Sponsor Role: collaborator

University Malaysia Sarawak

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Chee-Shee Chai, MD

Role: STUDY_DIRECTOR

Faculty of Medicine and Health Science, University Malaysia Sarawak

Locations

University Malaya Medical Center

Kuala Lumpur, Selangor, Malaysia

Countries

Malaysia

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

202089-8970

Identifier Type: -

Identifier Source: org_study_id