Geerts Jody A, Siemerink Ester J M, Sniehotta Falko F, Loman Lucie J M, Bode Christina, Pieterse Marcel E
Division of Oncology, Department of Internal Medicine, ZGT Hospital, Almelo, the Netherlands.
Department of Public Health, Social and Preventive Medicine, Centre for Preventive Medicine and Digital Health (CPD), Medical Faculty Mannheim, Heidelberg University, Mannheim, Germany.
Pilot Feasibility Stud. 2024 Dec 18;10(1):151. doi: 10.1186/s40814-024-01571-8.
Cancer-related fatigue (CRF) is the most prevalent, distressing, and quality of life disturbing symptom during and after cancer treatment for many cancer types including breast cancer. The experience and burden of this symptom can induce a cognitive bias towards fatigue or a fatigue-related self-image, which can further increase the fatigue symptoms and related behaviour. For this, a Cognitive Bias Modification (CBM) eHealth app (IVY) has been developed. The app aims to counter the fatigue-related self-image and to modify it towards vitality, which might translate to less experienced fatigue and more experienced vitality. This study aims to evaluate the feasibility of the IVY CBM training and the research design of a wait-list control trial. If feasibility is judged sufficient, the effectiveness of the CBM app will also be analyzed on (1) underlying mechanisms (cognitive fatigue bias), (2) symptom fatigue (self-reported fatigue and vitality), and (3) related behaviours (avoidance and all-or-nothing behaviour).
This feasibility study addresses individuals being treated for breast cancer receiving (neo)adjuvant treatment or metastatic care. The number of target participants is 120 (60 (neo)adjuvant, and 60 metastatic) patients. Both groups will be randomized with 30 people in the IVY treatment group and 30 people in the delayed treatment control group. All participants will receive the training via the IVY app, in which participants categorize words related to vitality with words related to 'I' and words related to fatigue with words related to 'other'. If feasibility is judged sufficient, the effects of the training will be explored on 3 levels: (1) self-identity bias, which will be measured with a short computer task based on the Implicit Association Test (IAT), (2) avoidance and all-or-nothing behaviour, and (3) fatigue and vitality levels, which will all be measured with questionnaires.
This study aims to evaluate the feasibility of a larger-scale multi-centre Randomized Controlled Trial (RCT) to investigate a novel eHealth application and, if possible, to give indications on the effectiveness of this intervention to counter fatigue in individuals with breast cancer. Using the IVY CBM app requires very little effort, both in time and cognitive load, which could be especially beneficial for fatigue symptoms.
Registered at the Open Science Framework (OSF; https://osf.io/e85g7/ ) on October 20, 2023.
癌症相关疲劳（CRF）是包括乳腺癌在内的多种癌症在治疗期间及治疗后最普遍、最令人痛苦且扰乱生活质量的症状。这种症状的体验和负担会引发对疲劳或与疲劳相关的自我形象的认知偏差，进而可能进一步加重疲劳症状及相关行为。为此，开发了一款认知偏差修正（CBM）电子健康应用程序（IVY）。该应用旨在对抗与疲劳相关的自我形象，并将其转变为充满活力的形象，这可能会转化为更少的疲劳体验和更多的活力体验。本研究旨在评估IVY CBM训练的可行性以及等待列表对照试验的研究设计。如果判断可行性足够，还将分析CBM应用程序在以下方面的有效性：（1）潜在机制（认知疲劳偏差），（2）症状性疲劳（自我报告的疲劳和活力），以及（3）相关行为（回避和非此即彼行为）。
本可行性研究针对正在接受（新）辅助治疗或转移性护理的乳腺癌患者。目标参与者人数为120名（60名接受（新）辅助治疗，60名患有转移性疾病）患者。两组将进行随机分组，IVY治疗组30人，延迟治疗对照组30人。所有参与者将通过IVY应用程序接受训练，在训练中，参与者将与活力相关的词汇与与“我”相关的词汇归为一类，将与疲劳相关的词汇与与“其他”相关的词汇归为一类。如果判断可行性足够，将在三个层面探索训练的效果：（1）自我认同偏差，通过基于内隐联想测验（IAT）的简短计算机任务进行测量；（2）回避和非此即彼行为；（3）疲劳和活力水平，均通过问卷调查进行测量。
本研究旨在评估一项更大规模的多中心随机对照试验（RCT）的可行性，以研究一种新型电子健康应用程序，并在可能的情况下，对该干预措施对抗乳腺癌患者疲劳的有效性给出指示。使用IVY CBM应用程序在时间和认知负荷方面所需的努力非常少，这对疲劳症状可能特别有益。
于2023年10月20日在开放科学框架（OSF；https://osf.io/e85g7/ ）注册。
