Graft-Versus-Host Disease Symptom Management-Cures

移植物抗宿主病症状管理-治愈

• 批准号: 10702724
• 负责人: Lori Wiener
• 金额: $ 4.71万
• 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/10702724
• 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; Extramural Activities; 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; Site; 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 multi-center 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, 31 participants have been enrolled on the study and 23 participants have successfully completed Project 1 study procedures (five 5-7-year-olds, four 8-12 year old, and fourteen 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. We enrolled the first participant from an extramural site on June 24, 2020.

这项多中心非干预性心理社会试验将解决研究目的， 两个项目：1）定性项目，使用认知访谈来确认 对PCSS的理解和易于响应，以及2）定量项目，以评估 PCSS的重测信度、结构效度和反应度，以及 探索患者和父母代理的症状评级的一致性。在项目1中，我们 对患者和代理人（父母/监护人）进行至少20次认知访谈， 每个年龄组（5-7岁; 8-12岁; 13-17岁）的60名患有cGVHD的儿童移植存活者样本 完善症状项目和应对选择，以确保它们在整个 发展光谱认知面试将评估的清晰度和理解力， PCSS项目，判断响应选择的容易性和准确性，以及 了解响应选择，并将根据研究数据完善PCSS， 在进入项目2之前。到目前为止，已有31名参与者参加了这项研究， 23名参与者成功完成了项目1的研究程序（5名5-7岁的儿童， 4名8-12岁，14名13-17岁。在项目2中，我们将评估重测 与NIH联合评估PCSS的可靠性、结构效度和反应性 总体cGVHD症状严重程度评分、Peds QL、器官特异性cGVHD的临床医生评级 严重程度评分和cGVHD严重程度，使用NIH标准，在120名儿童样本中 具有cGVHD的移植存活者反映了三个年龄组（5-7岁; 8-12岁; 13-17岁 年）的相同数量。在13-17岁的受试者中，我们还将比较PCSS的反应 与那些从李量表，以确定最年轻的年龄在青少年受访者 可以理解李氏量表我们招募了第一位来自校外网站的参与者， 2020年6月24日。