A Problem Solving Education Trial in Patients and Caregivers During HSCT

异基因造血干细胞移植（HSCT）会产生多种症状和问题，这些症状和问题的复杂性可能各不相同。虽然它似乎是显而易见的，病人和照顾者的经验，临床上显着的心理困扰水平，很少干预研究已经探讨，以解决这一问题，在这一人口。 解决问题是个人成功科普的一项基本技能。提高解决问题的技能已被证明可以减少心理困扰，并可能改善症状困扰和健康相关的生活质量（QOL）。科普（创造力，乐观，规划和专家信息）解决问题的教育（PSE）干预已被证明是有益的，并已被癌症患者及其家属报道为积极的治疗方法。 基于我们的试点研究和最近发表的报告的结果，本研究旨在确定在同种异体造血干细胞移植过程中，通过提高照顾者的自我效能来解决问题的教育的初步疗效。此外，本研究还探讨了与照顾者自我效能和痛苦变化相关的因素，如人口统计学、临床变量、相互关系、照顾者反应、睡眠质量、疲劳和健康行为。 这是一项采用前瞻性重复测量设计的II期临床试验。如果受试者同意在NIH临床中心参与同种异体HSCT，则受试者被纳入该方案，他们年龄> 18岁，能够阅读英语并且能够理解研究的研究性质。在整个研究期间，患者志愿者必须至少有一名护理人员。 本研究于2010年11月停止入组;仅开放用于数据分析。筛选了330名潜在受试者;入组了195名患者和护理志愿者。 除常规护理组教育外，还为每位护理人员（和患者）安排了三次个性化PSE干预会议（研究干预）。对所有研究参与者进行了三次调查。基线问卷调查进行了两次;一次在同种异体HSCT前，另一次在首次PSE前，即首次出院时。将在出院后6周进行干预后问卷调查。干预期后将不会进行长期随访。这些文件包括：痛苦温度计，家庭照顾清单相互关系量表，健康促进生活方式概况II，癌症自我效能量表，简明症状量表，照顾者反应评估，匹兹堡睡眠质量指数和多维疲劳症状量表-简表。此外，受试者在研究结束时参加了半结构化访谈，干预人员将填写一份日志，跟踪受试者出勤率、会话时长以及计划和实际会话日期和时间之间的差异。本研究将采用定量和定性分析技术。

Allogeneic hematopoietic stem cell transplantation (HSCT) generates multiple symptoms and problems that can vary in complexity. Although it seems evident that patients and caregivers experience clinically significant levels of psychological distress, few interventions studies have been explored to address this concern in this population. Problem-solving is an essential skill for individuals to successfully cope. Increased problem-solving skill has been shown to decrease psychological distress and may improve symptom distress and health related quality of life (QOL). The COPE (Creativity, Optimism, Planning, and Expert Information) problem-solving education (PSE) intervention has demonstrated benefit and has been reported as a positive therapy by cancer patients and their families. Based on the findings from our pilot study and recent published reports, this study is designed to determine preliminary efficacy of problem solving education by increasing self-efficacy in caregivers during allogeneic HSCT. In addition, this study explores factors associated with change in caregiver self-efficacy and distress such as demographics, clinical variables, mutuality, caregiver reaction, sleep quality, fatigue and health behaviors. This is a phase two clinical trial applying a prospective repeated measure design. Subjects were accrued to this protocol if they agreed to participate in an allogeneic HSCT at the Clinical Center, NIH, are > 18 years old, able to read English and able to comprehend the investigational nature of the study. Patient volunteers must have at least one caregiver throughout the study period. The study was closed to enrollment in November 2010; open for data anlysis only. 330 potential subjects were screened; 195 patient and careagiver volunteers were enrolled. Each caregiver (and patient) was scheduled for three individualized PSE intervention sessions (study intervention) in addition to the usual care group education. Three surveys were administered to all study participants. The baseline questionnaires were administered twice; once prior to allogeneic HSCT and again directly before the first PSE, at the time of initial discharge from the hospital. The post-intervention questionnaires will be administered 6 weeks post discharge. There will be no long term follow-up after the intervention period. Questionnaires include: Distress Thermometer, Family Caregiving Inventory Mutuality Scale, Health-Promoting Lifestyle Profile II, Cancer Self-Efficacy scale, Brief Symptom Inventory, Caregiver Reaction Assessment, Pittsburgh Sleep Quality Index and the Multidimensional Fatigue Symptom Inventory-Short Form. In addition, the subjects participated in a semi-structured interview at the end of the study and the interventionist will complete a log that tracks subject attendance, session length, and discrepancy between planned and actual session date and time. Quantitative and qualitative analysis techniques will be used in this study.