Clinical trial · Interventional
RCT of Effects of Mindfulness-based Stress Reduction in Head and Neck Cancer
Randomized Controlled Trial of Mindfulness-based Stress Reduction in Newly Diagnosed Head and Neck Cancer: Assessing Their Effect on Positive Psychology and Quality of Life
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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. 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. PTG, hope and optimism exerts partial mediation effects on the relationship between MBSR and quality of life among head and neck cancer patients.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer of Head and Neck | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Mindfulness-based Stress Reduction (MBSR) | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Mindfulness-based Stress Reduction (MBSR)
- description
- 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.
- interventionNames
- Behavioral: Mindfulness-based Stress Reduction (MBSR)
- type
- NO_INTERVENTION
- label
- Control
- description
- 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
Primary outcomes (1)
- measure
- 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
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion criteria: * 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. Exclusion criteria: * 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
References
Publications (2)
- DERIVEDZhang 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
- DERIVEDZhang 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