Quality of Life and Disease-related Symptoms in Individuals With Systemic Mastocytosis
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 400
- 试验地点
- 2
- 主要终点
- Self Care of Chronic Illness Inventory
研究概览
简要总结
Systemic Mastocytosis is a rare and complex disease caused by accumulation of mast cells. The skin, bones, gastrointestinal tract, bone marrow and liver are the organs most often affected. Symptoms can vary greatly between patients. The study aims to describe the Swedish cohort's self-rated quality of life and levels of disease-related symptoms.
详细描述
Systemic Mastocytosis (SM) is a rare and complex disease caused by accumulation of mast cells leading to release of mediator substances (e.g., cytokines, prostaglandins, histamine and tryptase). The skin, bones, gastrointestinal tract, bone marrow and liver are the organs most often affected. Symptoms vary between patients and can include e.g., allergic reactions with anaphylaxis, rashes, osteoporoses, cognitive difficulties, fatigue, depression, anxiety, nausea, vomiting, stomach pains and diarrhea. In this cross-sectional observational study, the aim is to include the Swedish cohort of persons diagnosed with SM to gather a wide range of information on self-rated health-related quality of life, gastrointestinal symptoms, pain, anxiety, depression and self-care.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
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
- •Swedish-speaking individuals aged 18 years or older and diagnosed with indolent systemic mastocytosis (ISM) or advanced systemic mastocytosis (AdvSM), verified by a bone marrow biopsy
排除标准
- •An assessment by the treating physician that the individual has a cognitive impairment making participation impossible
- •The patient has undergone an allogeneic stem cell transplant
结局指标
主要结局
Self Care of Chronic Illness Inventory
时间窗: Day 1
Self Care of Chronic Illness Inventory, 29 items, measures self-care behaviors in persons with chronic illnesses. The scale measures three aspects of self care; Self-Care Maintenance, Self-Care Monitoring (or Symptom Perception), and Self-Care Management. Scores on each scale are standardized to range from 0 to100 with higher scores indicating better self-care
EORTC QLQ C-30
时间窗: Day 1
EORTC QLQ C-30 measures health related quality of life rated by individuals with malignancies and the general population. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Thus, a high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems
The Mastocytosis Quality of Life Questionnaire (MC-QoL)
时间窗: Day 1
The Mastocytosis Quality of Life Questionnaire (MC-QoL), measures disease-specific quality of life items, has scores from 0 to 100, where higher scores indicate higher health-related quality-of-life impairment
The Hospital Anxiety and Depression Scale (HADS)
时间窗: Day 1
The Hospital Anxiety and Depression Scale (HADS), 14 items, is a screening tool for anxiety and depression in non-psychiatric clinical populations. There are 7 items for depression and 7 items for anxiety. Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression. A higher score indicates a higher level of distress.
The Gastrointestinal Symptom Rating Scale (GSRS)
时间窗: Day 1
The Gastrointestinal Symptom Rating Scale (GSRS), 15 items. This instrument measures The Gastrointestinal Symptom Rating Scale (GSRS). This instrument measures gastrointestinal symptoms in individuals with irritable bowel syndrome, gastric or duodenal ulcers and dyspepsia. The questionnaire, which contains 15 items, 6 subscales with total score between 19 to 133. Higher scores indicates more symptoms.
The Visceral Sensitivity Index (VSI)
时间窗: Day 1
The Visceral Sensitivity Index (VSI), 15 items, measures psychosocial consequences and worries of gastrointestinal symptoms. Each item scores 0-6 and a higher score indicates greater GI symptom-specific anxiety.
The Brief Pain Inventory - Short form (BPI-SF)
时间窗: day 1
The Brief Pain Inventory - Short form (BPI-SF), 9 items, yields a rating of levels of pain during a 24-hour period, and a description of the nature of that pain. The instrument also contains items on the impact (if any) of the pain of daily life. Each rating scale is bounded by the words "no pain" at the 0 end and "pain as bad as you can imagine" at the other. Using similar scales of 0 to 10, patients are also asked to rate the extent to which their pain interferes with 7 quality-of-life domains that include general activity, walking, mood, sleep, work, relations with other persons, and enjoyment of life. These scales are bounded by the words "does not interfere" and "interferes completely: Higher scores indicates higher levels of pain/Higher impact of pain on daily life.
The Brunnsviken Brief Quality of life scale (BBQ)
时间窗: Day 1
The Brunnsviken Brief Quality of life scale (BBQ), 12 items, has 4-graded response alternatives. The scale measures the overall self-experienced quality of life. The Satisfaction and Importance rating for each life area is multiplied and summed for a total quality of life score ((items 1 \* 2) + (items 3 \* 4) and so forth). Higher scores indicate higher levels of subjective QoL.
次要结局
未报告次要终点