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

NCT05010239 | Completed

• 1 other identifier: 202089-8970
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer; Suffering

Keywords

mindfulness; supportive; cancer; suffering; palliative

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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).

  30-minute

Secondary Outcomes (2)

• Perception of stress measured by Perceived Stress Scale

  30-minute

• Mindfulness measured by Frieburg Mindfulness Inventory

  30-minute

Study Arms (2)

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.

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.

Other: 30-minute supportive listening

Interventions

30-minute Mindfulness-Based Supportive Therapy 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.

Intervention group

30-minute supportive listening 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.

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patients who are confused based on The Confusion Assessment scoring (CAM)
• Patients who are non-communicative verbally
• Patients with psychiatric illness

Sponsors & Collaborators

• University Malaysia Sarawak: lead
• University of Malaya: collaborator

Study Sites (1)

University Malaya Medical Center

Kuala Lumpur, Selangor, 50603, Malaysia

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

• Chee-Shee Chai, MD

  Faculty of Medicine and Health Science, University Malaysia Sarawak

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Parallel group, single-blinded, randomized controlled trial

Study Record Dates

• First Submitted: August 10, 2021
• First Posted: August 18, 2021
• Study Start: August 1, 2020
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: August 18, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)