Rosenberg Abby R, Junkins Courtney C, Sherr Nicole, Scott Samantha, Klein Victoria, Barton Krysta S, Yi-Frazier Joyce P
Palliative Care and Resilience Lab, Seattle Children's Research Institute, Seattle, WA 98101, USA.
Department of Pediatrics, University of Washington School of Medicine, Seattle, WA 98105, USA.
Children (Basel). 2019 Oct 24;6(11):117. doi: 10.3390/children6110117.
Adolescents and young adults (AYAs) with cancer have poor psychosocial outcomes, in part because their limited participation in clinical trials precludes intervention-testing. We previously reported results of a successful randomized trial testing an AYA-targeted psychosocial intervention. Here, we aimed to describe strategies learned during the trial's conduct.
We summarized data from the medical record and staff field notes regarding reasons for participation/non-participation. We conducted two focus groups with study staff; directed content analyses identified strategies for success.
92 AYAs enrolled (77% of approached; = 50 Usual Care (control), = 49 PRISM (intervention)). In eligible families who declined participation ( = 22 AYAs, = 8 parents), the AYAs more commonly had advanced cancer ( = 11 (37%) declined vs. = 25 (26%) enrolled). AYA reasons for non-enrollment were predominantly "not interested"; parents worried participation was "too burdensome." Staff strategies for accrual included having significant time to introduce the study and underscoring a desire to learn from the patient. After enrollment, AYAs who discontinued participation were more commonly assigned to control ( = 5 (10%) control vs. = 2 (4%) intervention). Only = 1 AYA chose to discontinue participation after receiving the intervention.
Efforts to engage AYAs prior to and during studies may help with accrual and retention.
患有癌症的青少年和青年（AYA）心理社会结局较差，部分原因是他们参与临床试验的机会有限，无法进行干预测试。我们之前报告了一项成功的随机试验结果，该试验测试了一种针对AYA的心理社会干预措施。在此，我们旨在描述在试验过程中学到的策略。
我们总结了病历和工作人员现场记录中关于参与/不参与原因的数据。我们与研究人员进行了两个焦点小组讨论；定向内容分析确定了成功的策略。
92名AYA入组（占接触者的77%；n = 50接受常规护理（对照组），n = 49接受PRISM（干预组））。在拒绝参与的符合条件的家庭中（n = 22名AYA，n = 8名家长），AYA更常见的情况是患有晚期癌症（11名（37%）拒绝参与 vs. 25名（26%）入组）。AYA不参与的主要原因是“不感兴趣”；家长担心参与“负担过重”。工作人员的招募策略包括有足够的时间介绍研究并强调向患者学习的愿望。入组后，退出参与的AYA更常见于被分配到对照组（5名（10%）对照组 vs. 2名（4%）干预组）。只有1名AYA在接受干预后选择退出参与。
在研究前和研究期间努力让AYA参与可能有助于招募和留住参与者。
