The Impact of Acute Delirium On the Level of Distress In Patients With Advanced Cancer and Their Caregivers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Patient Level of Distress as related to Level of Delirium
研究概览
简要总结
Primary Objectives:
- To determine the proportion of patients who experience partial or complete recollection of symptoms of delirium and the level of distress associated with this recall.
- To determine caregiver's level of distress associated with the patient's episode of delirium.
详细描述
Informed Consent for Patients:
Delirium is often seen in patients with advanced cancer. Delirium is defined as confusion and restlessness. In this study, cancer patients will be asked about their memory of experiencing delirium and the distress related to those memories. Caregivers of those patients will also be asked to participate, and they will be asked questions about their experience during these situations.
You will be tested using the Memorial Delirium Assessment Scale to see if you have recovered from your delirium. If you are still eligible to take part in this study, and both you and your caregiver agree to participate in this study; you will be asked by the research nurse to complete several questionnaires that ask questions about your mental state, any memory of experiencing delirium, the severity of the delirium, symptoms you experienced during the delirium episode, and your level of emotional distress related to that event. If you and your caregiver are asked to participate in this study; you will also be asked "open-ended" questions (questions with no wrong answers) regarding the experience you had during the severe episode of delirium; your memories of the experience, and the overall distress related to it. This conversation will be tape recorded, and it will be written down word-for-word, for the purpose of analysis. The conversation is expected to last no more than 30 minutes.
The assessments and questionnaires will be conducted only at the time of interview. No further assessments or questions will be done after the completion of the study. All information collected for the study will be kept confidential. You will be assigned a study participant number when you enroll on the study, and this number will be used (instead of your name) on all data collections, to protect your confidentiality.
This is an investigational study. Up to 100 patients and 100 caregivers will take part in this study. All will be enrolled at M. D. Anderson.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Presence of advanced cancer, defined as local recurrent and/or metastatic.
- •History of an episode of delirium during the patient's current inpatient admission, diagnosis of delirium will be made by one of the palliative care specialists according to DSM-IV-TR criteria.
- •If the patient has a complete recovery from the episode of delirium, the patient must be approached within 3 days for the possibility of inclusion in study. "Complete recovery" will be defined as diagnosis of complete resolution of all symptoms of delirium according to DSM-IV-TR criteria by one of the palliative care specialists.
- •Ability to communicate in the English language.
- •Caregiver who is 18 years of age or older (assessments used in this study have not been validated in pediatric population), is able to communicate in English and comprehend the assessment questionnaire, and is at the bedside for a significant length of time (approximately 4 hours) each day during the delirium episode. Both the patient and their caregiver must agree to participate for inclusion in the study.
- •Written informed consent signed by the patients and the participating caregivers.
- •MDAS [Memorial Delirium Assessment Scale] < 13 (Scores of 13 or above likely reflect the presence of delirium).
- •Patients will be recruited from the palliative care mobile team or the inpatient palliative care unit.
排除标准
- •Refusal of both the patient and their caregiver to complete assessments
- •Inability to complete assessment due to sensorial deficits other than cognition; e.g. blindness, deafness, aphasia, etc., that might impact the patient's ability to recall the episode of delirium.
结局指标
主要结局
Patient Level of Distress as related to Level of Delirium
时间窗: 2 Years
Level of distress patients experience associated with delirium recall, made on a 0-4 numerical rating scale with 0=not at all and 4=extremely distressed. Summarized as a median score and as the most frequent response.
Number of patients who have partial or complete memory of experiencing any signs of delirium (confusion or restlessness)
时间窗: 2 Years
Interview with full assessment including demographic information, MMSE (Mini-Mental State Exam), DEQ (The Delirium Experience Questionnaire), and Delirium Recall Questionnaire for patient who experience complete recovery from an episode of delirium
次要结局
未报告次要终点