Stehl Meredith Lutz, Kazak Anne E, Alderfer Melissa A, Rodriguez Alyssa, Hwang Wei-Ting, Pai Ahna L H, Boeving Alexandra, Reilly Anne
Division of Oncology, The Children's Hospital of Philadelphia, Philadelphia, PA 19104-4399, USA.
J Pediatr Psychol. 2009 Sep;34(8):803-16. doi: 10.1093/jpepsy/jsn130. Epub 2008 Dec 17.
To report acceptability, feasibility, and outcome data from a randomized clinical trial (RCT) of a brief intervention for caregivers of children newly diagnosed with cancer.
Eighty-one families were randomly assigned following collection of baseline data to Intervention or Treatment as Usual (TAU). Recruitment and retention rates and progression through the protocol were tracked. Measures of state anxiety and posttraumatic stress symptoms served as outcomes.
Difficulties enrolling participants included a high percentage of newly diagnosed families failing to meet inclusion criteria (40%) and an unexpectedly low participation rate (23%). However, movement through the protocol was generally completed in a timely manner and those completing the intervention provided positive feedback. Outcome data showed no significant differences between the arms of the RCT.
There are many challenges inherent in conducting a RCT shortly after cancer diagnosis. Consideration of alternative research designs and optimal timing for interventions are essential next steps.
报告一项针对新诊断出癌症儿童的照料者的简短干预随机临床试验（RCT）的可接受性、可行性和结果数据。
在收集基线数据后，81个家庭被随机分配至干预组或常规治疗（TAU）组。追踪招募和留存率以及研究方案的推进情况。以状态焦虑和创伤后应激症状的测量结果作为指标。
招募参与者存在困难，包括高比例新诊断家庭不符合纳入标准（40%）以及参与率出乎意料地低（23%）。然而，研究方案的推进总体上及时完成，完成干预的人员给出了积极反馈。结果数据显示RCT的两组之间无显著差异。
在癌症诊断后不久开展RCT存在许多固有挑战。考虑替代研究设计和干预的最佳时机是接下来的关键步骤。
