Abstract：
OBJECTIVE: Assess the feasibility of a randomized controlled trial (RCT) exploring the use of medical imaging as a therapeutic education (TPE) intervention in external radiation therapy.
METHODS: Experimental feasibility trial of \"RCT\" type carried out in a single-center, between November 2019 and March 2020, following adult patients treated by thoracic radiotherapy. In addition to the information usually given, the experimental group benefited from an intervention consisting in the visualization of their own medical images using the open-source software \"Stone of Orthanc\".
RESULTS: Forty-nine patients were recruited with a refusal rate of 8.16% (4/49). 20 patients were withdrawn from the study for health reasons (COVID), 10 for medical reasons. All the remaining 15 participants completed the process. Although not significant, the experimental group showed a median gain in the perception of knowledge compared to the control group (+ 1.9 (1.6 - 2.2)) vs (+ 1.4 (1.4 - 1.8)), as well as a decrease in scores related to anxiety (- 3.0 (-4.5 - (-2.0)) vs - 1.0 (-5.0 - 0.0)) and emotional distress ((- 5.0 (- 7.5 - (- 3.5)) vs (- 2.0 (- 5.0 - (- 1.0)) A significant reduction (p=0.043) is observed for the depression score ((- 2.0 (-3.0 - (-1.5)) vs (0.0 (0.0 - 0.0)).
CONCLUSIONS: This study demonstrates the feasibility of the project, with promising preliminary results. Some adaptations in order to conduct a larger-scale RCT are highlighted.
METHODS: Experimental feasibility trial of \"RCT\" type carried out in a single-center, between November 2019 and March 2020, following adult patients treated by thoracic radiotherapy. In addition to the information usually given, the experimental group benefited from an intervention consisting in the visualization of their own medical images using the open-source software \"Stone of Orthanc\".
RESULTS: Forty-nine patients were recruited with a refusal rate of 8.16% (4/49). 20 patients were withdrawn from the study for health reasons (COVID), 10 for medical reasons. All the remaining 15 participants completed the process. Although not significant, the experimental group showed a median gain in the perception of knowledge compared to the control group (+ 1.9 (1.6 - 2.2)) vs (+ 1.4 (1.4 - 1.8)), as well as a decrease in scores related to anxiety (- 3.0 (-4.5 - (-2.0)) vs - 1.0 (-5.0 - 0.0)) and emotional distress ((- 5.0 (- 7.5 - (- 3.5)) vs (- 2.0 (- 5.0 - (- 1.0)) A significant reduction (p=0.043) is observed for the depression score ((- 2.0 (-3.0 - (-1.5)) vs (0.0 (0.0 - 0.0)).
CONCLUSIONS: This study demonstrates the feasibility of the project, with promising preliminary results. Some adaptations in order to conduct a larger-scale RCT are highlighted.
摘要：
目的：评估一项随机对照试验（RCT）的可行性，探索将医学影像学作为外放射治疗的治疗教育（TPE）干预。
方法：在单中心进行的“RCT”类型的实验性可行性试验，2019年11月至2020年3月，在接受胸部放疗的成年患者之后。除了通常提供的信息，实验组受益于使用开源软件“Orthanc之石”对自己的医学图像进行可视化的干预。
结果：纳入49例患者，拒绝率为8.16%(4/49)。20名患者因健康原因退出研究(COVID)，10出于医学原因其余15名参与者完成了该过程。虽然不重要，与对照组相比，实验组对知识的感知中位数增加（1.9（1.6-2.2））vs（1.4（1.4-1.8）），以及与焦虑（-3.0（-4.5-（-2.0））vs-1.0（-5.0-0.0））和情绪困扰（-5.0（-7.5-（-3.5））vs（-2.0（-5.0-（-1.0））相关的评分降低，抑郁评分（-2.0（-3.0-（-1.5））vs（0.0（0.0-0.0）））显着降低（p=0.043）。
结论：这项研究证明了该项目的可行性，有希望的初步结果。强调了一些进行大规模RCT的调整。
方法：在单中心进行的“RCT”类型的实验性可行性试验，2019年11月至2020年3月，在接受胸部放疗的成年患者之后。除了通常提供的信息，实验组受益于使用开源软件“Orthanc之石”对自己的医学图像进行可视化的干预。
结果：纳入49例患者，拒绝率为8.16%(4/49)。20名患者因健康原因退出研究(COVID)，10出于医学原因其余15名参与者完成了该过程。虽然不重要，与对照组相比，实验组对知识的感知中位数增加（1.9（1.6-2.2））vs（1.4（1.4-1.8）），以及与焦虑（-3.0（-4.5-（-2.0））vs-1.0（-5.0-0.0））和情绪困扰（-5.0（-7.5-（-3.5））vs（-2.0（-5.0-（-1.0））相关的评分降低，抑郁评分（-2.0（-3.0-（-1.5））vs（0.0（0.0-0.0）））显着降低（p=0.043）。
结论：这项研究证明了该项目的可行性，有希望的初步结果。强调了一些进行大规模RCT的调整。
