Røyset Inga, Saltvedt Ingvild, Rostoft Siri, Grønberg Bjørn Henning, Kirkevold Øyvind, Oldervoll Line, Bye Asta, Benth Jūratė Šaltytė, Bergh Sverre, Melby Line, Halsteinli Vidar, Døhl Øystein, Røstad Tove, Eriksen Guro Falk, Sollid May Ingvild Volungholen, Rolfson Darryl, Slaaen Marit
Department of Neuromedicine and Movement Science, Faculty of Medicine and Health Science, Norwegian University of Science and Technology (NTNU), NO-7491 Trondheim, Norway; Department of Geriatric Medicine, Clinic of Medicine, St. Olavs Hospital, Trondheim University Hospital, Box 3250, Torgarden, NO-7006 Trondheim, Norway; The Research Centre for Age-related Functional Decline and Disease, Innlandet Hospital Trust, Box 68, NO-2312 Ottestad, Norway.
Department of Neuromedicine and Movement Science, Faculty of Medicine and Health Science, Norwegian University of Science and Technology (NTNU), NO-7491 Trondheim, Norway; Department of Geriatric Medicine, Clinic of Medicine, St. Olavs Hospital, Trondheim University Hospital, Box 3250, Torgarden, NO-7006 Trondheim, Norway.
J Geriatr Oncol. 2022 Apr;13(3):363-373. doi: 10.1016/j.jgo.2021.11.001. Epub 2021 Nov 12.
About 50% of patients with cancer are expected to need radiotherapy (RT), and the majority of these are older. To improve outcomes for older patients with cancer, geriatric assessment (GA) with management (GAM) is highly recommended. Evidence for its benefits is still scarce, in particular for patients receiving RT. We report the protocol of a cluster-randomised pilot study designed to test the effect, feasibility and health economic impact of a GAM intervention for patients ≥65 years, referred for palliative or curative RT. The randomising units are municipalities and city districts. The intervention is municipality-based and carried out in collaboration between hospital and municipal health services from the start of RT to eight weeks after the end of RT. Its main constituents are an initial GA followed by measures adapted to individual patients' impairments and needs, systematic symptom assessments and regular follow-up by municipal cancer nurses, appointed to coordinate the patient's care. Follow-up includes at least one weekly phone call, and a house call four weeks after the end of RT. All patients receive an individually adapted physical exercise program and nutritional counselling. Detailed guidelines for management of patients' impairments are provided. Patients allocated to the intervention group will be compared to controls receiving standard care. The primary outcome is physical function assessed by the European Organisation of Research and Treatment of Cancer Quality of Life Questionnaire C-30. Secondary outcomes are global quality of life, objectively tested physical performance and use of health care services. Economic evaluation will be based on a comparison of costs and effects (measured by the main outcome measures). Feasibility will be assessed with mixed methodology, based on log notes and questionnaires filled in by the municipal nurses and interviews with patients and nurses. The study is carried out at two Norwegian RT centres. It was opened in May 2019. Follow-up will proceed until June 2022. Statistical analyses will start by the end of 2021. We expect the trial to provide important new knowledge about the effect, feasibility and costs of a GAM intervention for older patients receiving RT. Trial registration: ClinTrials.gov, ID NCT03881137, initial release 13th of March 2019.
约50%的癌症患者预计需要放疗（RT），其中大多数为老年患者。为改善老年癌症患者的治疗效果，强烈推荐进行老年评估（GA）及管理（GAM）。其益处的证据仍然稀少，尤其是对于接受放疗的患者。我们报告了一项整群随机试点研究的方案，该研究旨在测试针对≥65岁、因姑息性或根治性放疗而转诊的患者进行GAM干预的效果、可行性和卫生经济影响。随机分组单位是市和市区。干预以市为基础，从放疗开始至放疗结束后八周，由医院和市卫生服务部门合作开展。其主要组成部分包括初始GA，随后是根据个体患者的损伤和需求采取的措施、系统的症状评估以及由市癌症护士进行的定期随访，市癌症护士被指定协调患者的护理。随访包括至少每周一次电话随访，以及放疗结束四周后的上门家访。所有患者都将接受个性化的体育锻炼计划和营养咨询。提供了患者损伤管理的详细指南。分配到干预组的患者将与接受标准护理的对照组进行比较。主要结局是通过欧洲癌症研究与治疗组织生活质量问卷C-30评估的身体功能。次要结局包括总体生活质量、客观测试的身体表现以及医疗服务的使用情况。经济评估将基于成本和效果（以主要结局指标衡量）的比较。可行性将采用混合方法进行评估，基于市护士填写的日志记录和问卷以及对患者和护士的访谈。该研究在挪威的两个放疗中心进行。于2019年5月启动。随访将持续至2022年6月。统计分析将于2021年底开始。我们期望该试验能提供关于GAM干预对接受放疗的老年患者的效果、可行性和成本的重要新知识。试验注册：ClinicalTrials.gov，ID NCT03881137，初始发布于2019年3月13日。
