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Graft-Versus-Host Disease Symptom Management-Cures

移植物抗宿主病症状管理-治愈

基本信息

批准号：
10926372
负责人：
Lori Wiener
金额：
$ 4.27万
依托单位：
DIVISION OF BASIC SCIENCES - NCI
依托单位国家：
美国
项目类别：
财政年份：
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/10926372
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 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 Recommendation 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 improved instrument pediatric patients psychosocial response side effect symptom management transplant survivor

项目摘要

This multi-center non-interventional psychosocial trial addresses 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 are being used to 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, 52 participants have been enrolled on the study and 41 participants have successfully completed Project 1 study procedures (8 5-7-year-olds, 14 8-12 year olds, and 19 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通过两个项目实现了研究目的：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人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。认知访谈被用来评估PCSS项目的清晰度和理解力，对响应选择的判断的容易性和准确性，以及理解响应选择的任何错误，并将根据研究数据改进PCSS，然后进行项目2。迄今为止，已有52名参与者入组研究，41名参与者成功完成了项目1研究程序（8名5-7岁儿童，14名8-12岁奥尔兹和19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。我们于2020年6月24日从校外研究中心招募了第一名参与者。

项目成果

期刊论文数量（14）

专著数量（0）

科研奖励数量（0）

会议论文数量（0）

专利数量（0）

Care Provider Behaviors That Shape Parent Identity as a "Good Parent" to Their Seriously Ill Child.

DOI：
10.1089/pmr.2021.0005
发表时间：
2021
期刊：
Palliative medicine reports
影响因子：
2.5
作者：
Neumann ML;Weaver MS;Lord B;Wiener L;Hinds PS
通讯作者：
Hinds PS

Global Experiences of Pediatric Palliative Care Teams During the First 6 Months of the SARS-CoV-2 Pandemic.

DOI：
10.1016/j.jpainsymman.2021.03.016
发表时间：
2021-09
期刊：
Journal of pain and symptom management
影响因子：
4.7
作者：
McNeil MJ;Kaye EC;Vedaraju Y;Baker JN;Devidas M;Downing J;Graetz D;Ranadive R;Rosenberg AR;Wiener L;Weaver MS
通讯作者：
Weaver MS

Stuck Moments and Silver-Linings: The Spectrum of Adaptation Among Non-Bereaved and Bereaved Parents of Adolescents and Young Adults With Advanced Cancer.