Feasibility Study of Adjunctive Bright Light Therapy (BLT) for Amelioration of Fatigue in Chinese Cancer Patients Admitted to a Palliative Care Unit
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Rate of declined particilation in the study
研究概览
简要总结
Fatigue is the most common symptom in palliative care patients who have advanced cancer. Fatigue is also one of the most underreported hence under-treated symptoms. Patients may perceive it as a condition to be endured, whereas healthcare workers find it very challenging to assess and treat due to its subjective nature and multi-dimensional causes.
However, evidence-based practice to tackle this distressing problem is still inadequate, and that a one-size fit all approach is unrealistic. Various pharmacological options have been examined, but due to limited evidence, no specific drug could be recommended.
Latest development in management of fatigue includes non-pharmacological approach. Bright Light Treatment (BLT) has also evolved as a favourable treatment for cancer-related fatigue. BLT is the prescription of artificial bright light over a designated period of time. Recent clinical evidence showed that BLT reduced symptom of fatigue in patients undergoing active chemotherapy and cancer survivours.
There is however no data on bright light therapy used in in-patient palliative care settings.
A single group, prospective interventional study will be conducted in in-patient palliative care unit of Shatin Hospital (N = 42). The aim is to assess the feasibility and impact of BLT as an in-patient intervention in a cohort of local Chinese palliative care in-patients diagnosed with incurable cancer with documented symptom of fatigue, and to ascertain the changes of fatigue, mood, sleep and quality of life after 1-week exposure of BLT.
详细描述
Fatigue is the most common symptom in palliative care patients who have advanced cancer, ranging from 59% to 77% depends on the assessment method (1). There is limited local data on the prevalence of fatigue in cancer patients. A cross-sectional study by Dr KY Lam in 2009 (unpublished data) found 53% of 55 patients receiving palliative care suffered from severe fatigue. A cross-sectional symptom screening of all the patients in the palliative care ward in Shatin Hospital showed 22 out of 55 (40%) patients reported fatigue (unpublished data).
The fatigue experienced by cancer patients is multi-dimensional. The feeling may be a physical sensation (weakness, tiredness, exhaustion, unable to perform tasks), an affective sensation (low mood, lack of motivation), or a cognitive sensation (lack of concentration, difficulty thinking clearly). This phenomenon is also subject to cultural interpretation therefore there is a need to understand each subject's perception and experience of fatigue within his or her own cultural context (2, 3).
Fatigue is also one of the most under-reported hence under-treated symptoms. Patients may perceive it as a condition to be endured, whereas healthcare workers find it very challenging to assess and treat due to its subjective nature and multidimensional causes. The impairment in self-care capabilities and daily functioning lead to negative effects on desire to continue treatment thus affecting the functional recovery even in patients with a more stable disease status (3-5). The quality of life (QOL) of patients, which is our focus in palliative care service, is heavily reduced (6).
However, evidence-based practice to tackle this distressing problem is still inadequate, and that a one-size fit all approach is unrealistic (7). Various pharmacological options have been examined, but due to limited evidence, no specific drug could be recommended for the treatment of fatigue in palliative care patients in the latest Cochrane review in 2015 (8).
Latest development in management of fatigue includes non-pharmacological approach. Effect size in reducing fatigue in various treatments were summarised in a report by Bower (9). Exercise was more effective than control in reducing fatigue with a mean effect size of -0.27. Psychosocial intervention trials that included fatigue as a primary or secondary outcome have shown reductions in fatigue relative to control, with effective sizes ranging from -0.10 to -0.31. Psychostimulant trials, most of which were conducted among patients with advanced disease and used methylphenidate, suggested that psychostimulants were more effective than placebo in improving fatigue with an effect size of -0.28. Of note, two studies with larger sample size showed no benefit for methylphenidate vs. placebo for improving fatigue (10, 11). The application of non-pharmacological approach in our local patients was even more limited. A pilot study of 26 patients receiving palliative care in Shatin Hospital showed a mean change score of 0.5 (1.862) of improvement in Brief Fatigue Inventory (BFI) Q3 after two weeks of in-patient multidisciplinary care (unpublished data). The estimated effect size of the pilot study was 0.268 (mean change/SD = 0.5/1.863). Overall, these data suggest that non-pharmacological treatments (e.g. exercise, psychoeducation, support program, cognitive-behavioural therapy) have a mild to moderate effect on improving symptom of fatigue.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
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
- •Adult patient aged 18 years old or above
- •Chinese ethnic group
- •Diagnosis of incurable cancer
- •A score of >=3 in Brief Fatigue Inventory after a period of standard care
排除标准
- •Patients who are imminently dying
- •Patients who are undergoing chemotherapy or radiotherapy
- •Patients who have history of epilepsy, brain tumour, brain metastasis
- •Patients who are blind or have retinal disease
- •Patents who have photosensitive skin condition
- •Patients who have history of bipolar disorder as BLT has been suggested to increase the risk of manic swing in patients with bipolar disorder
- •Patients who have their dosage of antidepressants adjusted within 6 weeks
- •Patients who have difficulties to communicate effectively
- •Patients with impaired mental status precluding the completion of the questionnaire (AMT <5)
- •Patients who are unable to give valid consent
结局指标
主要结局
Rate of declined particilation in the study
时间窗: At screening stage
Rate of approached potential subjects who declined participation in the study
Attrition rate
时间窗: 1 week of the intervention
Rate of subject drop out (all cause)
Change in brief fatigue inventory
时间窗: Pre- and post- the 1-week intervention
Change of scoreing of the brief fatigue inventory (BFI) from baseline to end of treatment. BFI is a 9-item questionnaire measured in 11-point Likert scale. It evaluates the level of present, overall and worst fatigue together with its interference to patients' general activity, mood, walking ability, normal work, relationships with other people and enjoyment of life during the past 24 hours. A higher score means a worse outcome.
次要结局
- Change in McGill Quality of Life Questionnaire - Hong Kong(Pre- and post- the 1-week intervention)
- Change in Pittsburgh Sleep Quality Index(Pre- and post- the 1-week intervention)
- Change in Hospital Anxiety and Depression Scale(Pre- and post- the 1-week intervention)
研究者
Tang Heng Joshua
Deparment of Medicine & Geriatrics, Resident, Principal Investigator
Hospital Authority, Hong Kong
