RCT of Effects of Mindfulness-based Stress Reduction in Head and Neck Cancer

NCT04800419 | Completed DMC

• 1 other identifier: MFLeong
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

Head and neck cancer is a group of biologically similar cancers which cause deleterious impact, such as the complication of facial disfigurement which may increase the psychological vulnerability of patients due to the society's emphasis on physical attractiveness. The appearance of facial disfigurement can increase depression and reduced quality of life (QoL) in head and neck cancer patients. Among the positive psychology developed in cancer patients despite their negative experience of cancer and the adverse effects of its treatment are posttraumatic growth (PTG) and hope which may enhance the QoL of cancer patients. Several psychosocial interventions have been suggested to enhance positive psychology in cancer patients and increase in their QoL. Data is lacking on the efficacy of mindfulness-based stress reduction (MBSR) on enhancing positive psychology (such as PTG, optimism and hope) and QoL among head and neck cancer patients. This is a multicentre, 2-armed longitudinal double blind randomized control trial aimed to test the study hypotheses of:

1. 1.Head and neck cancer patients in the mindfulness-based stress reduction (MBSR) group reported significantly increase in posttraumatic growth (PTG), hope, optimism, and quality of life compared with those in the control group at post-intervention and 12 weeks after completion of intervention when compared with pre-intervention.
2. 2.PTG, hope and optimism exerts partial mediation effects on the relationship between MBSR and quality of life among head and neck cancer patients.

Conditions

Cancer of Head and Neck

Keywords

Mindfulness; Posttraumatic Growth; Hope; Optimism; Quality of Life

Outcome Measures

Primary Outcomes (1)

• Change in quality of life of head and neck cancer patients at 6 weeks immediately after completion of intervention and 12 weeks after completion of intervention

  Functional Assessment of Cancer Therapy - Head \& Neck (FACT-H \& N) is a self-reported tool which measures quality of life in patients with head and neck cancer. FACT-HN consists of 39 items and consists of 5 subscales: physical well-being (7 items), social/family well-being (7 items), emotional well-being (6 items), functional well-being (7 items) and head \& neck cancer additional concerns (12 items). Each item is scored in a 5-point Likert scale ranging from 0= Not at all to 4= Very much. Hence, the total score range from 0 to 156. The higher the score, the greater is the degree of QoL. The tool also registered excellent psychometric properties. The FACT-H \& N has been translated and validated in the Malaysian cancer population. All the subscales have moderate to good internal consistency with Cronbach's α ranging from 0.65 to 0.87. In this study, it is used to assess level of QoL among the participants.

  pre-intervention, 6 weeks- immediately after completion of intervention, and 12 weeks after completion of intervention

Secondary Outcomes (3)

• Change in level of hope of head and neck cancer patients at 6 weeks immediately after completion of intervention and 12 weeks after completion of intervention

  pre-intervention, 6 weeks- immediately after completion of intervention, and 12 weeks after completion of intervention

• Change in optimism of head and neck cancer patients at 6 weeks immediately after completion of intervention and 12 weeks after completion of intervention

  pre-intervention, 6 weeks- immediately after completion of intervention, and 12 weeks after completion of intervention

• Change in posttraumatic growth of head and neck cancer patients at 6 weeks immediately after completion of intervention and 12 weeks after completion of intervention

  pre-intervention, 6 weeks-immediately after completion of intervention, 12 weeks after completion of intervention

Study Arms (2)

Mindfulness-based Stress Reduction (MBSR)

EXPERIMENTAL

MBSR will be conducted in a group of 10 for each session. The MBSR modules covered over 8 sessions, 1 hour in each session. The sessions will be held every week according to the patient's appointment date for chemotherapy treatment.

Behavioral: Mindfulness-based Stress Reduction (MBSR)

Control

NO INTERVENTION

The subjects in the TAU control group will be assigned for non-therapeutic sessions at the same time and of equal duration to that of the MBSR group

Interventions

Mindfulness-based Stress Reduction (MBSR) BEHAVIORAL

The term 'mindfulness' refers to mindful awareness as a way of being - a knowing and experiencing of feelings, thoughts, and perceptions as they arise and pass away each moment. It is a way of relating to all experiences in an open, receptive way, without judging experiences as good or bad (grasping at them or pushing them away). Mindfulness employed two styles of meditations: concentrative meditation involves intentionally focusing attention on a chosen object (e.g. the sensations of breathing) in a sustained way, while receptive meditation involves monitoring the content of experience (e.g. sensations, emotions, thoughts, sounds, etc.) in a non-reactive and non-judgmental way, from moment to moment, with the goal being to recognize the nature of emotional and cognitive patterns. Mindfulness-based stress reduction (MBSR) is an 8-week, standardized group intervention consisting of mindfulness meditation and gentle yoga that is designed to have applications for stress, pain, and illness

Mindfulness-based Stress Reduction (MBSR)

Eligibility Criteria

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

You may qualify if:

• Those who are newly diagnosed with head and neck cancer confirmed by histopathological examination report at any stage of cancer and who already completed surgical treatment and currently undergoing adjuvant treatment (such as chemotherapy and/or radiotherapy/brachytherapy or immunotherapy)
• Those who are literate in the Malay language (Bahasa Melayu)
• Age 18 years and above.

You may not qualify if:

• Those with history of pre-existing psychiatric illnesses, such as depression, anxiety disorders, schizophrenia, schizophreniform disorder, schizoaffective disorder, delusional disorder, brief psychotic disorder, bipolar mood disorder, posttraumatic stress disorder, obsessive compulsive disorder, and neurodevelopmental disorders (patients are screened with Mini International Neuropsychiatric Interview to exclude these disorders).
• Those with history of illicit drug intake and those with substance use disorder, alcohol use disorder, substance-related disorders and alcohol-related disorders (patients are screened with urine dipstick for drugs and Mini International Neuropsychiatric Interview to exclude these conditions).
• Those with history of medical illnesses which can induced psychiatric symptoms such as stroke, coronary heart disease, congestive cardiac failure, COPD, bronchial asthma, systemic lupus erythematosus, rheumatoid arthritis, renal failure, hepatic failure, endocrine disorders, multiple sclerosis, Parkinson's Disease, and epilepsy.
• Those who are currently on any psychotherapy or counselling sessions.
• Those who are physically unfit to perform intervention.
• Those who exhibit cognitive impairment (patients are screen with Montreal Cognitive Assessment, in which those with score of \< 25/30 will be excluded)
• Those with suicidal tendency
• Those who are pregnant

Sponsors & Collaborators

• Universiti Sains Malaysia: lead
• Xinxiang medical university: collaborator

Study Sites (1)

Advanced Medical and Dental Institute, Universiti Sains Malaysia

Kepala Batas, Pulau Pinang, 13200, Malaysia

Location

Related Publications (2)

• Zhang Z, Zhang Q, Lu P, Shari NI, Nik Jaafar NR, Mohamad Yunus MR, Leong Bin Abdullah MFI. MBSR effects on positive psychological traits and experiential avoidance in head and neck cancer: a randomized controlled trial. Eur J Psychotraumatol. 2025 Dec;16(1):2501822. doi: 10.1080/20008066.2025.2501822. Epub 2025 May 19.

  PMID: 40387873 DERIVED

• Zhang Z, Leong Bin Abdullah MFI, Shari NI, Lu P. Acceptance and commitment therapy versus mindfulness-based stress reduction for newly diagnosed head and neck cancer patients: A randomized controlled trial assessing efficacy for positive psychology, depression, anxiety, and quality of life. PLoS One. 2022 May 10;17(5):e0267887. doi: 10.1371/journal.pone.0267887. eCollection 2022.

  PMID: 35536828 DERIVED

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

Mindfulness-Based Stress Reduction

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Mindfulness; Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Mohammad Farris Iman Leong Bin Abdullah, Dr Psych

  Advanced Medical and Dental Institute, Universiti Sains Malaysia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: March 10, 2021
• First Posted: March 16, 2021
• Study Start: January 1, 2022
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2023
• Last Updated: September 10, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)