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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- 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
研究概览
简要总结
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:
- 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.
- PTG, hope and optimism exerts partial mediation effects on the relationship between MBSR and quality of life among head and neck cancer patients.
详细描述
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 on physical attractiveness. Moreover, a number of devastating complications of the cancer itself and the side effects of its treatment such as fatigue, pain, problem with speech and swallowing, breathing problem, mucositis, xerostomia, and trismus which further exerts detrimental effects on many functions and activities of daily living which causes further psychological distress and decreasing quality of life. Hence, it is of utmost importance to investigate on psychosocial interventions which could enhance PTG, hope, optimism and QoL of head and neck cancer patients which in turn bring about the ultimate outcome of restoring mental and physical well-being of the cancer survivors. Mindfulness-based stress reduction (MBSR) have been reported to enhance positive psychology in cancer patients. But the effect of MBSR on PTG, hope, optimism, and QoL among head and neck cancer patients have not been studied. Hence, there is a need to conduct a 2-armed randomized control trial to evaluate the effects of MBSR on PTG, hope, optimism, and QoL compared with control group with treatment-as-usual (TAU) across time.
Below are the objectives of this study:
General objective:
To examine the effects of mindfulness-based stress reduction (MBSR) on posttraumatic growth (PTG), hope, optimism, and quality of life among head and neck cancer patients.
Specific objectives:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Mindfulness-based Stress Reduction (MBSR)
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.
干预措施: Mindfulness-based Stress Reduction (MBSR) (Behavioral)
Control
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
结局指标
主要结局
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
时间窗: pre-intervention, 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.
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
时间窗: pre-intervention, 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.
次要结局
- 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)
- 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 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 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)
研究者
Mohammad Farris Iman Leong Bin Abdullah
Dr.
Universiti Sains Malaysia