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程度各不相同。虽然患者和照顾者在临床上经历显著的心理困扰似乎是显而易见的，但很少有干预研究来解决这一人群中的这种担忧。 解决问题是个人成功应对问题的基本技能。增加解决问题的技能已被证明可以减少心理痛苦，并可能改善症状痛苦和与健康相关的生活质量(QOL)。COPE(创造力、乐观主义、计划和专家信息)问题解决教育(PSE)干预已显示出益处，并已被癌症患者及其家人报告为一种积极的治疗方法。 根据我们的初步研究结果和最近发表的报告，这项研究旨在通过提高异基因造血干细胞移植期间照顾者的自我效能来确定问题解决教育的初步效果。此外，本研究还将探讨与照顾者自我效能感和痛苦改变相关的因素，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。 这是一项应用前瞻性重复测量设计的第二阶段临床试验。如果受试者同意参加美国国立卫生研究院临床中心的异基因造血干细胞移植，且他们年满18岁，能够阅读英语，并能够理解研究的研究性质，那么他们将被累加到这个方案中。在整个研究期间，患者志愿者必须至少有一名照顾者。需要对至少71名照顾者进行抽样，才能充分评估PSE干预的有效性。为了实现对71名照顾者的抽样，将招募50名移植患者。 这项研究于2010年11月关闭，仅供数据分析。330名潜在受试者被筛选；195名患者和照顾者志愿者入选。 每个照顾者(和患者)除了常规的照顾组教育外，还被安排进行三次个性化的PSE干预会议(研究干预)。对所有研究参与者进行了三次调查。基线问卷进行了两次；一次是在异基因造血干细胞移植之前，另一次是在第一次PSE之前，也就是首次出院时。干预后问卷将在出院后6周进行。在干预期过后，将不会有长期的随访。问卷包括：痛苦体温计、家庭护理问卷、健康促进生活方式问卷II、癌症自我效能量表、简明症状问卷、照顾者反应评定量表、匹兹堡睡眠质量指数和多维疲劳症状问卷-简表。此外，受试者在研究结束时参加了半结构化访谈，干预者将完成一份记录，记录受试者的出席情况、会议时长以及计划和实际会议日期和时间之间的差异。本研究将采用定量和定性分析相结合的研究方法。

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 will explore 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 will be accrued to this protocol if they agree to participation 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. A sample of at least 71 caregivers is needed to adequately evaluate the effectiveness of the PSE intervention. In order to achieve a sample of 71 caregivers 50 transplant patients will be recruited. 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.