CompletedNot Applicable

Mindfulness-based Stress Reduction Effects on Depression, Anxiety and Internalized Stigma Compared With Treatment-As-Usual Among Head and Neck Cancer Patients

Malaysia110 participantsStarted 2022-01-01

Plain-language summary

Head and neck cancer patients are vulnerable to various psychological complications due to the effects of both cancer itself and cancer treatment on patients' appearance and physical well-being. Nevertheless, few data have been obtained on effective psychosocial interventions that could protect this group of cancer patients' psychological well-being. Therefore, this two-armed, parallel-group, double-blind, randomized control trial (RCT) aims to evaluate and compare the effects of mindfulness-based stress reduction (MBSR) on psychosocial complications (depression, anxiety, and internalized stigma) among newly diagnosed head and neck cancer patients. This RCT will target newly diagnosed head and neck cancer patients who have been treated only with surgery or who have not yet received any treatment. In total, 106 patients who meet all of the study's inclusion criteria and none of its exclusion criteria will be randomly assigned into two groups-an MBSR group and a treatment-as-usual control group-at a 1:1' allocation ratio. Participants in the intervention group (MBSR group) will undergo an eight-week group intervention program. During this program, each intervention will comprise eight modules based on MBSR manual. Outcome assessments will be performed across a three-point timeline, including before the intervention (T0), immediately after the psychosocial intervention at eight weeks (T1), and 12 weeks after the intervention (T2). The primary outcome that will be assessed during this RCT is the severity of depression and anxiety. Meanwhile, the secondary outcome that will be evaluated in this study is such as internalized stigma.

Who can participate

Age range18 Years – 60 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * those diagnosed with HNC confirmed by histopathological report and at any stage of cancer * those aged 18 years old and above * those who have completed surgery and started chemotherapy and/or radiotherapy * literate in the Malay language. Exclusion Criteria: * history of pre-existing psychiatric illnesses (such as psychotic disorder, bipolar disorder, anxiety disorder, depressive disorder, neurodevelopmental disorder, neurocognitive disorder) * history of pre-existing medical illnesses which may induce psychiatric symptoms (such as kidney and liver failure, ischemic heart disease, epilepsy, hyperthyroidism, hypothyroidism, Cushing's syndrome, Addison's disease, systemic lupus erythematosus, neurological disorder, rheumatoid arthritis) * history of illicit drug and alcohol use * pregnancy * suicidal tendency * those with history of engaged in other psychotherapy * those who are not physically and cognitively fit to participate in the study

What they're measuring

Hospital Anxiety and Depression Scale

Timeframe: Change of the mean HADS Depression and Anxiety Subscale scores between baseline and 8 weeks of commence of intervention and between 8 weeks of commence of intervention to 12 weeks after completion of intervention

Trial details

NCT IDNCT06991309

SponsorUniversiti Sains Malaysia

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-06-30