A SMART approach to optimizing delivery of an mHealth intervention among cancer survivors with posttraumatic stress symptoms.

A SMART approach to optimizing delivery of an mHealth intervention among cancer survivors with posttraumatic stress symptoms.
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DOI:
10.1016/j.cct.2021.106569
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发表时间:
2021-11
影响因子:
2.2
通讯作者:
Applebaum AJ
Applebaum AJ
中科院分区:
医学4区
文献类型:
--
作者:
Smith SK;Somers TJ;Kuhn E;Laber E;Sung AD;Syrjala KL;Feger B;Kelleher SA;Majestic C;Gebert R;LeBlanc M;Owen JE;Applebaum AJ

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许多接受造血干细胞移植(HCT)等强化治疗的癌症幸存者都会出现创伤后应激障碍(PTSD)症状。PTSD与生活质量降低和其他需要临床治疗的症状有关。在临床实践中发生的迭代治疗决策在传统的PTSD治疗随机对照试验(RCT)中没有得到充分的代表。拟议的阶梯式护理SMART设计允许评估对癌症苦恼教练移动的应用程序的初始响应;自适应阶梯式护理干预;以及根据患者特征定制治疗选择的精确治疗策略。在两个癌症中心招募了报告PTSD症状的HCT幸存者(N=400),并随机分配到:1)癌症苦恼教练应用程序或2)家庭护理。该应用程序包括基于教育和认知行为疗法(CBT)的活动。随机分组后四周,参与者重新评估他们的PTSD症状,并且基于干预反应,无反应者被重新随机分配以接受与治疗师的视频会议:3)使用移动的应用程序的辅导课程;或4)HCT幸存者特定的CBT。参与者在1个月、3个月和6个月后完成PTSD、抑郁和焦虑的结果测量。参与者特征调节干预反应将进行检查。这种新的适应性试验设计将提供证据,进一步了解优化HCT幸存者的PTSD干预措施。据我们所知,这项研究是第一个评估癌症幸存者PTSD症状管理的SMART设计。如果成功,它可以用于优化一系列癌症和其他创伤幸存者的治疗。
Many cancer survivors who received intensive treatment such as hematopoietic stem cell transplantation (HCT) experience posttraumatic stress disorder (PTSD) symptoms. PTSD is associated with lower quality of life and other symptoms that require clinical treatment. The iterative treatment decisions that happen in clinical practice are not adequately represented in traditional randomized controlled trials (RCT) of PTSD treatments. The proposed stepped-care SMART design allows for evaluation of initial response to the Cancer Distress Coach mobile app; adaptive stepped-care interventions; and precision treatment strategies that tailor treatment selection to patient characteristics. HCT survivors (N=400) reporting PTSD symptoms are being recruited at two cancer centers and randomly assigned to: 1) Cancer Distress Coach app or 2) Usual Care. The app includes educational and cognitive behavioral therapy (CBT)-based activities. Four weeks post-randomization, participants re-rate their PTSD symptoms and, based on intervention response, non-responders are re-randomized to receive video-conferenced sessions with a therapist: 3) coaching sessions in using the mobile app; or 4) CBT specific to HCT survivors. Participants complete outcome measures of PTSD, depression, and anxiety after Months 1, 3, and 6. Participant characteristics moderating intervention responses will be examined. This novel adaptive trial design will afford evidence that furthers knowledge about optimizing PTSD interventions for HCT survivors. To our knowledge, this study is the first SMART design evaluating PTSD symptom management in cancer survivors. If successful, it could be used to optimize treatment among a range of cancer and other trauma survivors.
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