65岁以上血液系统恶性肿瘤 (OCAPI) 患者个体化体育锻炼计划：单臂可行性试验方案
患有癌症的老年人受到衰弱、癌症疾病和治疗副作用的综合影响。血液系统恶性肿瘤患者的主要治疗方法是化疗，化疗具显著毒性。化疗可以改变患者的身体机能和生活质量，而这些在老年患者中往往已经由于衰弱和合并症而降低。因此，开发和评估能够预防身体和社会心理衰退及其后果的干预措施是必不可少的。促进身体活动是改善老年癌症患者身体功能和生活质量的一种很有前景的方法，但关于此类干预措施在伴有化疗的老年血液系统恶性肿瘤患者中的可行性的数据有限。
OCAPI（On Cogeriatric and Individualized Physical Activity）是一项单臂、跨学科、前瞻性、干预性、可行性研究。它旨在将 65 岁以上的 40 名患者（20 名急性髓性白血病患者和 20 名非霍奇金淋巴瘤患者）纳入个性化的 6 个月体育锻炼计划。该计划包括单独监督的锻炼课程，在家里和/或在层流室（取决于疾病和治疗方案）中增加体力活动量，然后是无人监督的课程和电话随访。在该计划的 6 个月内，患者将收到一个活动追踪器。评估将在入组时和第 3、6 和 12 个月进行，以评估该计划的可行性并探索身体、心理社会和临床结局。结果将生成初步数据以实施更大的随机对照试验。
研究方案已获得法国伦理委员会的批准（Comité de protection des personnes Est I, N°ID-RCB 2019-A01231-56，2019 年 7 月 12 日）。所有参与者都必须签署知情同意书并注明日期。研究结果将在同行评审的期刊和学术会议上传播。
Older adults with cancer suffer from the combined effects of ageing, cancer disease and treatment side effects. The main treatment for patients with haematological malignancies is chemotherapy, associated with significant toxicities. Chemotherapy can alter patients’ physical function and quality of life which are often already diminished in older patients due to ageing and comorbidities. It therefore seems essential to develop and to evaluate interventions capable of preventing physical and psychosocial decline and its consequences. Promoting physical activity is a promising approach to improve physical function and quality of life in older adults with cancer, but there are limited data on the feasibility of such interventions among older patients with haematological malignancies, concomitant to chemotherapy.
OCAPI (OnCogeriatric and Individualized Physical Activity) is a single-arm, interdisciplinary, prospective, interventional, feasibility study. It is intended to include 40 patients (20 patients with acute myeloid leukaemia and 20 patients with non-Hodgkin’s lymphoma) over 65 years in an individualised 6-month physical activity programme. The programme consists of individually supervised exercise sessions with an increasing volume of physical activity either at home and/or in a laminar airflow room (depending on the disease and treatment regimen) followed by unsupervised sessions and phone follow-ups. Patients will receive an activity tracker during the 6 months of the programme. Evaluations will take place at inclusion and at 3, 6 and 12 months to assess the feasibility of the programme and to explore potential changes in physical, psychosocial and clinical outcomes. The results will generate preliminary data to implement a larger randomised controlled trial.
The study protocol was approved by the French ethics committee (Comité de protection des personnes Est I, N°ID-RCB 2019-A01231-56, 12 July 2019). All participants will have to sign and date an informed consent form. The findings will be disseminated in peer-reviewed journals and academic conferences.
https://bmjopen.bmj.com/content/11/6/e046409
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