Physical & Emotional Health of Caregivers for People Who Had Stem Cell Transplant

在美国，大约有6570万名无薪护理人员，估计有8%的人为癌症患者提供护理。虽然已经报道了有益的发现，但为患有癌症的配偶或亲人提供护理是有压力的，并且可能对个人的心理和身体健康产生负面影响。在癌症照顾者中，研究记录了负面结果，包括疲劳症状，睡眠质量受损，生活质量差，焦虑和抑郁。这些结果是特别值得关注的癌症患者接受密集的治疗，如造血干细胞移植（HSCT），其中照顾者嵌入在治疗轨迹，可以延长4 - 12个月。 很少有研究探讨可能影响HSCT照顾者心血管疾病总体风险的生理和临床因素之间的关联。虽然有证据表明，癌症照顾者所经历的深刻压力似乎与自主神经系统失调有关，但很少有现有证据表明这种失调与心血管风险有关。在移植护理人员中，证据更加缺乏，没有发表的研究检查了随着时间的推移在这一人群中发生的生理和行为变化，也没有这些人因协助他们所爱的人通过与移植相关的恐惧和痛苦而面临的压倒性负担而面临的心血管风险。 本研究的设计来自于先前在NIH临床中心完成的初步研究和II期研究的结果。来自这些研究的数据，沿着来自我们先前分析的结果，提供了重要的信息，以告知本初步研究的设计，该研究将探索同种异体HSCT护理者样本中慢性应激和心血管风险的生理和临床标志物。 本研究的主要目的是比较HSCT照顾者与非照顾者之间心血管疾病的生理和生物标志物。还招募了年龄、性别和人种/种族最低匹配的非护理人员样本参与研究，作为每例入组护理人员受试者的研究对照。计划的主要分析需要完成所有3个时间点的40例受试者样本（20名护理人员和20名非护理人员志愿者）。本研究最初于2011年9月30日获得IRB批准。研究招募于2011年11月开始;第1例受试者于2011年12月入组。截至2012年9月，已入组N=42例受试者（n=22例HSCT护理人员受试者和n=20例匹配的正常志愿者）。 每个护理者参与者在移植接受者HSCT之前（第0天）、在移植接受者从住院环境初次出院后的第一周门诊访视期间、以及最后在移植接受者从医院初次出院后6周收集数据。这些文件包括：照顾者反应评估（仅照顾者）、健康促进生活方式概况II、感知压力量表、UCLA孤独量表（第3版）、一般自我效能量表和PROMIS焦虑、抑郁、睡眠障碍和疲劳简表。在临床访视期间，收集护理人员和匹配的正常志愿者受试者的临床变量（例如生命体征）、生理变量（例如皮质醇）、问卷和病史以及有限的体格检查。

There are approximately 65.7 million unpaid caregivers in the United States with an estimated 8% providing care to someone with cancer. Although benefit-finding has been reported, providing care to a spouse or loved one with cancer is stressful and can have negative consequences for an individuals psychological and physical health. In cancer caregivers, studies have documented negative outcomes including symptoms of fatigue, impaired sleep quality, poor quality of life, anxiety and depression. These outcomes are of particular concern when cancer patients receive intense treatment such as hematopoietic stem cell transplantation (HSCT) where caregivers are embedded in a treatment trajectory that can extend 4 12 months. Few studies have explored the association among physiological and clinical factors that may affect HSCT caregivers overall risk for cardiovascular disease. While there is evidence indicating that the profound stress experienced by cancer caregivers appears to be associated with autonomic nervous system dysregulation, very little existing evidence suggests that this dysregulation is related to cardiovascular risk. The evidence is lacking even more in transplant caregivers, where no published studies have examined the physiological and behavioral changes that occur in this population over time, nor the cardiovascular risk these individuals face as a result of the overwhelming burden of assisting their loved one through the fear and suffering associated with transplantation. The design of this study was informed from the results of a prior pilot study and phase II study completed at the NIH, Clinical Center. Data from these studies, along with findings from our prior analyses have provided essential information to inform the design of this pilot study which will explore the physiological and clinical markers of chronic stress and cardiovascular risk in a sample of allogeneic HSCT caregivers. The primary objective of this study is to compare physiologic and biomarkers of cardiovascular illness among HSCT caregivers to non-caregivers. A sample of non-caregivers, matched minimally for age, gender, and race/ethnicity are also recruited study participation to serve as study control for each enrolled caregiver subject. A sample of 40 subjects (20 caregiver and 20 non-caregiver volunteers) completing all 3 time points is required for the planned primary analysis. The study was approved by the IRB originally on September 30, 2011. Study recruitment began in November 2011; the 1st subject was enrolled in December 2011. As of As of September 2012, N=42 subjects (n=22 HSCT caregiver subjects and n=20 matching normal volunteers) have been enrolled. Each caregiver participant has data collected prior to the transplant recipients HSCT (day 0), during the first week of outpatient visits following the transplant recipients initial discharge from the inpatient setting, and finally 6 weeks post the transplant recipients initial discharge from the hospital. Questionnaires include: Caregiver Reaction Assessment (caregivers only), Health-Promoting Lifestyle Profile II, Perceived Stress Scale, The UCLA Loneliness Scale (Version 3), General Self-Efficacy Scale, and PROMIS Short Forms for Anxiety, Depression, Sleep disturbance and Fatigue. Clinical variables (e.g. vital signs), physiological variables (e.g. cortisol), questionnaires and a medical history and limited physical exam are collected during the clinic visits for both caregiver and matched normal volunteer subjects.