Lown E Anne, Banerjee Anu, Vittinghoff Eric, Dvorak Christopher C, Hartogensis Wendy, Melton Alexis, Mangurian Christina, Hu Hiroe, Shear Deborah, Adcock Robyn, Morgan Michael, Golden Carla, Hecht Frederick M
Social and Behavioral Sciences, School of Nursing, University of California, San Francisco, California.
Department of Neurological Surgery, University of California, San Francisco, California.
Glob Adv Health Med. 2019 Aug 14;8:2164956119870444. doi: 10.1177/2164956119870444. eCollection 2019.
We describe the study design and protocol of a pragmatic randomized controlled trial (RCT) Acupressure for Children in Treatment for a Childhood Cancer (ACT-CC).
To describe the feasibility and effectiveness of an acupressure intervention to decrease treatment-related symptoms in children in treatment for cancer or recipients of a chemotherapy-based hematopoietic stem cell transplant (HSCT).
Two-armed RCTs with enrollment of 5 to 30 study days.
Two pediatric teaching hospitals.
Eighty-five children receiving cancer treatment or a chemotherapy-based HSCT each with 1 parent or caregiver.
Patients are randomized 1:1 to receive either usual care plus daily professional acupressure and caregiver delivered acupressure versus usual care alone for symptom management. Participants receive up to 20 professional treatments.
A composite nausea/vomiting measure for the child.
Child's nausea, vomiting, pain, fatigue, depression, anxiety, and positive affect.
Depression, anxiety, posttraumatic stress symptoms, caregiver self-efficacy, and positive affect. Feasibility of delivering the semistandardized intervention will be described. Linear mixed models will be used to compare outcomes between arms in children and parents, allowing for variability in diagnosis, treatment, and age.
Trial results could help childhood cancer and HSCT treatment centers decide about the regular inclusion of trained acupressure providers to support symptom management.
我们描述了一项针对儿童癌症治疗中的穴位按压实用随机对照试验（RCT）“儿童癌症治疗中的穴位按压”（ACT - CC）的研究设计和方案。
描述穴位按压干预对减轻癌症治疗儿童或接受化疗的造血干细胞移植（HSCT）受者治疗相关症状的可行性和有效性。
双臂随机对照试验，入组时间为5至30个研究日。
两家儿科教学医院。
85名接受癌症治疗或化疗的HSCT儿童，每名儿童有1名家长或照料者。
患者按1:1随机分组，分别接受常规护理加每日专业穴位按压及照料者进行的穴位按压，或仅接受常规护理以进行症状管理。参与者最多接受20次专业治疗。
针对儿童的恶心/呕吐综合测量指标。
儿童的恶心、呕吐、疼痛、疲劳、抑郁、焦虑和积极情绪。
抑郁、焦虑、创伤后应激症状、照料者自我效能感和积极情绪。将描述实施半标准化干预措施的可行性。将使用线性混合模型比较儿童和家长两组之间的结局，同时考虑诊断、治疗和年龄的差异。
试验结果有助于儿童癌症和HSCT治疗中心决定是否定期纳入经过培训的穴位按压提供者以支持症状管理。
