Graft-Versus-Host Disease Symptom Management-Cures

移植物抗宿主病症状管理-治愈

• 批准号: 10262515
• 负责人: Lori Wiener
• 金额: $ 96.73万
• 依托单位: DIVISION OF BASIC SCIENCES - NCI
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10262515
• 关键词: 12 year old; 17 year old; 7 year old; Address; Adolescent; Adult; Affect; Age; Child; Childhood; Chronic Disease; Clinical Trials; Companions; Comprehension; Consensus; Data; Development; Enrollment; Ensure; Eye; Face; Genetic Diseases; Hematopoietic Stem Cell Transplantation; Immunosuppression; Intestines; Judgment; Liver; Lung; Malignant Childhood Neoplasm; Measures; Musculoskeletal System; Oral cavity; Organ; Outcome Measure; Pain; Parents; Participant; Patient Outcomes Assessments; Patients; Population; Procedures; Proxy; Psychometrics; Respondent; Sampling; Severities; Severity of illness; Skin; Standardization; Stem cell transplant; Steroids; Symptoms; Testing; Transplantation; United States National Institutes of Health; age group; chronic graft versus host disease; cognitive interview; graft vs host disease; instrument; pediatric patients; psychosocial; response; side effect; symptom management; transplant survivor

This multicenter non-interventional psychosocial trial will address the study aims in two projects: 1) a qualitative project using cognitive interviewing to confirm the comprehension and ease of response to the PCSS, and 2) a quantitative project to evaluate test-retest reliability, construct validity and responsiveness of the PCSS, as well as to explore concordance of symptom ratings by patients and parent proxies. In Project 1, we will conduct at least 20 cognitive interviews of patient and proxy dyads (parent/guardian) within each age group (5-7; 8-12; 13-17) for a sample of 60 pediatric transplant survivors with cGVHD to refine the symptom items and response choices to ensure that they resonate across the developmental spectrum. Cognitive interviews will evaluate the clarity and comprehension of the PCSS items, the ease and accuracy of judgement of the response choices, and any errors in understanding the response choices, and will refine the PCSS in accordance with study data, before proceeding to Project 2. To date, seven participants have been enrolled on the study and 6 participants have successfully completed Project 1 study procedures (three 5-7-year-olds, one 8-12 year old, and two 13-17-year-olds. In Project 2, we will evaluate test-retest reliability, construct validity, and responsiveness of the PCSS, in association with the NIH Global cGVHD Symptom Severity Score, the Peds QL, clinician ratings of organ specific cGVHD severity scores and cGVHD severity using the NIH criteria, in a sample of 120 pediatric transplant survivors with cGVHD reflecting three age groups (5-7 years; 8-12 years; 13-17 years) of equal numbers. In subjects ages 13-17, we will also compare responses on the PCSS with those from the Lee Scale, to determine the youngest age at which adolescent respondents can comprehend the Lee Scale.

这项多中心非干预性心理社会试验将在两个项目中实现研究目的：1）一个定性项目，使用认知访谈确认对PCSS的理解和反应的容易程度; 2）一个定量项目，评价PCSS的重测信度、结构效度和反应性，以及探索患者和父母代理的症状评分的一致性。在项目1中，我们将对每个年龄组（5-7岁; 8-12岁; 13-17岁）的60名患有cGVHD的儿科移植幸存者进行至少20次患者和代理二人组（父母/监护人）的认知访谈，以完善症状项目和反应选择，以确保它们在整个发育谱中产生共鸣。认知访谈将评估PCSS项目的清晰度和理解力、判断回答选择的难易程度和准确性，以及理解回答选择时的任何错误，并将根据研究数据完善PCSS，然后进行项目2。到目前为止，已有7名参与者入组研究，6名参与者成功完成了项目1的研究程序（3名5-7岁儿童，1名8-12岁儿童和2名13-17岁儿童。在项目2中，我们将评估PCSS的重测信度、结构效度和反应性，并结合NIH全球cGVHD症状严重程度评分、Peds QL、临床医生对器官特异性cGVHD严重程度评分的评级以及使用NIH标准的cGVHD严重程度，在反映三个年龄组的120名儿童移植存活者中进行（5-7岁; 8-12岁; 13-17岁）人数相等。在13-17岁的受试者中，我们还将比较PCSS的回答与Lee量表的回答，以确定青少年受访者能够理解Lee量表的最小年龄。