A multisite randomized controlled trial of an early palliative care intervention in children with advanced cancer: The PediQUEST Response Study Protocol

被引:7
作者
Dussel, Veronica [1 ,2 ]
Orellana, Liliana [3 ]
Holder, Rachel [4 ]
Porth, Rachel [5 ]
Avery, Madeline [6 ]
Wolfe, Joanne [6 ,7 ,8 ,9 ]
机构
[1] Dana Farber Boston Childrens Canc & Blood Disorde, Pediat Palliat Care, Boston, MA 02115 USA
[2] Ctr Res & Implementat Palliat Care, Inst Clin Effectiveness & Hlth Policy, Buenos Aires, Argentina
[3] Deakin Univ, Biostat Unit, Geelong, Vic, Australia
[4] Virginia Commonwealth Univ, Dept Psychol, Richmond, VA USA
[5] Beth Israel Deaconess Med Ctr, Dept Internal Med, Boston, MA USA
[6] Dana Farber Canc Inst, Dept Psychosocial Oncol & Palliat Care, Boston, MA USA
[7] Dana Farber Canc Inst, Dept Pediat Oncol, Boston, MA USA
[8] Boston Childrens Hosp, Dept Pediat, Boston, MA USA
[9] Harvard Med Sch, Boston, MA USA
来源
PLOS ONE | 2022年 / 17卷 / 11期
基金
美国国家卫生研究院;
关键词
QUALITY-OF-LIFE; MULTIPLE INFORMANTS; SYMPTOM ASSESSMENT; END; PARENTS; OUTCOMES; DEATH; COMMUNICATION; CONSULTATION; FEASIBILITY;
D O I
10.1371/journal.pone.0277212
中图分类号
O [数理科学和化学]; P [天文学、地球科学]; Q [生物科学]; N [自然科学总论];
学科分类号
07 ; 0710 ; 09 ;
摘要
Background The Pediatric Quality of Life and Evaluation of Symptoms Technology Response to Pediatric Oncology Symptom Experience (PQ-Response) intervention aims to integrate specialized pediatric palliative care into the routine care of children, adolescents, and young adults (AYAs) with advanced cancer. Aims To evaluate whether PQ-Response, compared to usual care, improves patient's health related quality of life (HRQoL) and symptom burden (aim 1), parent psychological distress and symptom-related stress (aim 2), and family and symptom treatment activation (aim 3). Design Multisite, randomized (1:1), controlled, un-blinded, effectiveness trial comparing PediQUEST Response (intervention) vs usual cancer care (control). Setting Five US large, tertiary level pediatric cancer centers. Participants Children (>= 2 years old)/AYAs who receive care at any of the participating sites because of advanced cancer or any progressive/recurrent solid or brain tumor and are palliative care "naive." Target: 200 enrolled patient-parent dyads (minimum goal: 136 dyads randomized, N = 68/arm). Interventions PediQUEST Response: combines patient-mediated activation (weekly feedback of patient- and parent-reported symptoms and HRQoL to families and providers using the PediQUEST web system) with integration of the palliative care team. Usual Cancer Care: participants receive usual care, which can include palliative care consultation, and use PediQUEST web to answer surveys, with no feedback. Methods Following enrollment, patients (if >= 5 years) and one parent receive weekly PediQUEST-Surveys assessing HRQoL (Pediatric Quality of Life Inventory 4.0) and symptom burden (PediQUEST-Memorial Symptom Assessment Scale). After a 2-week run-in period, dyads who answer >= 2 PediQUEST surveys per participant (responders), are randomized (concealed allocation) and followed up for 16-weeks. Parents answer six additional surveys (parent outcomes). Outcomes Primary: mean patient HRQoL score over 16-weeks as reported by a) the parent; and b) the patient if >= 5 years-old. Secondary: patient's symptom burden; parent's anxiety, depressive symptoms, symptom-related stress; family activation; and symptom treatment activation.
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页数:21
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