Status:
COMPLETED
RCT of Effects of Mindfulness-based Stress Reduction in Head and Neck Cancer
Lead Sponsor:
Universiti Sains Malaysia
Collaborating Sponsors:
Xinxiang medical university
Conditions:
Cancer of Head and Neck
Eligibility:
All Genders
18+ years
Phase:
NA
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 p...
Detailed Description
As head and neck cancer differ from other types of cancer due to the complication of facial disfigurement which may increase the psychological vulnerability of patients due to the society's emphasis o...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
January 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2023
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT04800419
Start Date
January 1 2022
End Date
June 30 2023
Last Update
September 10 2025
Active Locations (1)
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1
Advanced Medical and Dental Institute, Universiti Sains Malaysia
Kepala Batas, Pulau Pinang, Malaysia, 13200