Lie Hanne C, Anderssen Sigmund, Rueegg Corina Silvia, Raastad Truls, Grydeland May, Thorsen Lene, Stensrud Trine, Edvardsen Elisabeth, Larsen Marie Hamilton, Torsvik Ingrid Kristin, Bovim Lars Peder, Götte Miriam, Lähteenmäki Päivi Maria, Kriemler Susi, Larsen Hanne Bækgaard, Fridh Martin Kaj, Ørstavik Kristin, Brun Henrik, Matthews Iren, Hornset Else, Ruud Ellen
Department of Behavioural Medicine, Institute of Basic Medical Sciences, Faculty of Medicine, University of Oslo, Oslo, Norway.
Department of Sports Medicine, Norwegian School of Sport Sciences, Oslo, Norway.
JMIR Res Protoc. 2022 Mar 8;11(3):e35838. doi: 10.2196/35838.
Survivors of childhood cancer represent a growing population with a long life expectancy but high risks of treatment-induced morbidity and premature mortality. Regular physical activity (PA) may improve their long-term health; however, high-quality empirical knowledge is sparse.
The Physical Activity and Fitness in Childhood Cancer Survivors (PACCS) study comprises 4 work packages (WPs) aiming for the objective determination of PA and self-reported health behavior, fatigue, and quality of life (WP 1); physical fitness determination (WP 2); the evaluation of barriers to and facilitators of PA (WP 1 and 3); and the feasibility testing of an intervention to increase PA and physical fitness (WP 4).
The PACCS study will use a mixed methods design, combining patient-reported outcome measures and objective clinical and physiological assessments with qualitative data gathering methods. A total of 500 survivors of childhood cancer aged 9 to 18 years with ≥1 year after treatment completion will be recruited in follow-up care clinics in Norway, Denmark, Finland, Germany, and Switzerland. All participants will participate in WP 1, of which approximately 150, 40, and 30 will be recruited to WP 2, WP3, and WP 4, respectively. The reference material for WP 1 is available from existing studies, whereas WP 2 will recruit healthy controls. PA levels will be measured using ActiGraph accelerometers and self-reports. Validated questionnaires will be used to assess health behaviors, fatigue, and quality of life. Physical fitness will be measured by a cardiopulmonary exercise test, isometric muscle strength tests, and muscle power and endurance tests. Limiting factors will be identified via neurological, pulmonary, and cardiac evaluations and the assessment of body composition and muscle size. Semistructured, qualitative interviews, analyzed using systematic text condensation, will identify the perceived barriers to and facilitators of PA for survivors of childhood cancer. In WP 4, we will evaluate the feasibility of a 6-month personalized PA intervention with the involvement of local structures.
Ethical approvals have been secured at all participating sites (Norwegian Regional Committee for Medical Research Ethics [2016/953 and 2018/739]; the Oslo University Hospital Data Protection Officer; equivalent institutions in Finland, Denmark [file H-19032270], Germany, and Switzerland [Ethics Committee of Northwestern and Central Switzerland, project ID: 2019-00410]). Data collection for WP 1 to 3 is complete. This will be completed by July 2022 for WP 4. Several publications are already in preparation, and 2 have been published.
The PACCS study will generate high-quality knowledge that will contribute to the development of an evidence-based PA intervention for young survivors of childhood cancer to improve their long-term care and health. We will identify physiological, psychological, and social barriers to PA that can be targeted in interventions with immediate benefits for young survivors of childhood cancer in need of rehabilitation.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/35838.
儿童癌症幸存者群体日益壮大，他们预期寿命长，但因治疗导致发病和过早死亡的风险很高。定期体育活动（PA）可能会改善他们的长期健康状况；然而，高质量的实证知识却很匮乏。
儿童癌症幸存者的体育活动与健康状况（PACCS）研究包括4个工作包（WP），旨在客观测定体育活动及自我报告的健康行为、疲劳和生活质量（工作包1）；测定身体素质（工作包2）；评估体育活动的障碍因素和促进因素（工作包1和3）；以及对增加体育活动和身体素质的干预措施进行可行性测试（工作包4）。
PACCS研究将采用混合方法设计，将患者报告的结局指标与客观的临床和生理评估相结合，并运用定性数据收集方法。在挪威、丹麦、芬兰、德国和瑞士的后续护理诊所，将招募总共500名9至18岁、治疗结束后≥1年的儿童癌症幸存者。所有参与者都将参与工作包1，其中大约150人、40人和30人将分别被招募到工作包2、工作包3和工作包4。工作包l的参考资料可从现有研究中获取，而工作包2将招募健康对照者。将使用ActiGraph加速度计和自我报告来测量体育活动水平。将使用经过验证的问卷来评估健康行为、疲劳和生活质量。将通过心肺运动测试、等长肌肉力量测试以及肌肉力量和耐力测试来测量身体素质。将通过神经学、肺部和心脏评估以及身体成分和肌肉大小的评估来确定限制因素。将采用系统文本浓缩法分析半结构化定性访谈，以确定儿童癌症幸存者体育活动的感知障碍因素和促进因素。在工作包4中，我们将评估一项为期6个月的个性化体育活动干预措施在当地机构参与下的可行性。
所有参与地点均已获得伦理批准（挪威医学研究伦理区域委员会[2016/953和2018/739]；奥斯陆大学医院数据保护官；芬兰、丹麦[档案H-19032270]、德国和瑞士的同等机构[瑞士西北部和中部伦理委员会，项目编号：2019-00410]）。工作包1至工作包3的数据收集已完成。工作包4将于2022年7月完成。已有多篇论文正在撰写中，2篇已发表。
PACCS研究将产生高质量的知识，这将有助于为儿童癌症年轻幸存者制定基于证据的体育活动干预措施，以改善他们的长期护理和健康状况。我们将确定体育活动的生理、心理和社会障碍因素，这些因素可在干预措施中作为目标，从而立即惠及需要康复的儿童癌症年轻幸存者。
国际注册报告识别码（IRRID）：DERR1-10.2196/35838。
