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    • The Feasibility and Acceptability of a Home-Based, Virtual Exercise Intervention for Older Patients with Hepatocellular Carcinoma: Protocol for a Non-Randomised Feasibility Study (Telex-Liver Cancer)

    Orange Samuel T.,Hallsworth Kate,Brown Morven C.,Reeves Helen L.

    Blood purification（2024）SCI 4区

    Newcastle University Centre for Cancer | Newcastle University

    Cited 4|Views1
    Abstract
    Background The number of incident cases and deaths from primary liver cancer, predominantly hepatocellular carcinoma (HCC), has increased markedly in the last two decades. HCC is generally diagnosed at an advanced stage, and most new cases are in people aged over 70 years with age-related comorbidities. Treatment options are often limited, with most patients receiving palliative treatment or supportive care only. As a consequence, maintaining quality of life (QoL) through symptom management is critically important and is a core objective of clinical care. Strong evidence supports the efficacy of supervised exercise training for addressing certain cancer-related symptoms, including QoL, physical function, and fatigue. However, there are many barriers to implementing supervised exercise programmes within cancer care pathways, including economic pressures on healthcare systems and personal barriers for patients. Recent advances in technology allow patients to exercise at home under the ‘virtual’ supervision of an exercise professional through videoconferencing software (termed ‘telehealth exercise’). Despite its potential, there are uncertainties relating to the feasibility, acceptability, and safety of telehealth exercise in people living with HCC. Methods This is a protocol for a prospective, single-centre, single-arm, pretest-posttest feasibility trial. We aim to recruit 20 patients aged 60 years or older who have received treatment for HCC and are undergoing routine clinical monitoring. Patients will be invited to take part in two online, home-based, group exercise sessions per week for 10 consecutive weeks. The ‘virtual’ exercise sessions will be delivered in real time by an exercise professional through videoconferencing software. Each session will comprise 30 min of aerobic and resistance exercise performed at a moderate intensity, as guided by the 10-point Borg rating of perceived exertion scale. Feasibility outcomes include recruitment, retention, adherence, intervention fidelity, and safety. Acceptability of the intervention will be assessed using a mixed-methods approach via monthly online surveys and an exit telephone interview. Physical function, accelerometry-measured physical activity, mid-upper arm circumference, and patient-reported outcome measures (PROMS) will be assessed before and after the intervention to determine the feasibility of assessing outcome measures. Physical function outcomes include the short physical performance battery and Liver Frailty Index. PROMS include the Functional Assessment of Cancer Therapy-Hepatobiliary questionnaire, Functional Assessment of Chronic Illness Therapy-Fatigue questionnaire, Activities-specific Balance Confidence scale, Hospital Anxiety and Depression Scale, and the Godin Leisure-Time Exercise Questionnaire. Discussion This mixed-methods study will address uncertainties relating to the feasibility and acceptability of delivering live, online, home-based, group exercise sessions to patients with HCC. The findings will inform whether any modifications are required to refine and optimise the intervention, and the assessment of outcome measures will provide information on the likely size and variability of intervention effects. Collectively, the data generated will inform the design of a subsequent, adequately powered, randomised controlled trial to evaluate the efficacy of the telehealth exercise intervention. Trial registration ISRCTN14411809
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    Liver cancer,Exercise intervention,Telehealth,Quality of life,Feasibility
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    【要点】：本研究旨在探讨基于家庭虚拟锻炼干预对老年肝细胞癌患者的可行性和可接受性，创新性地采用远程视频监督锻炼作为干预手段。
    

    【方法】：通过前瞻性、单中心、单臂、前后测试的可行性试验，对60岁及以上、已接受肝细胞癌治疗且正在接受常规临床监测的患者进行评估。
    

    【实验】：患者被邀请每周参与两次在线家庭团体锻炼，为期10周，通过视频会议软件实时由锻炼专业人士指导，每次锻炼包括30分钟的中等强度有氧和抗阻训练。可行性结果包括招募、保留、依从性、干预忠实性和安全性。干预的可接受性将通过混合方法评估，包括每月在线调查和退出电话访谈。在干预前后评估身体功能、加速度计测量的身体活动、中上臂围度和患者报告的结果测量（PROMS），以确定评估结果指标的可行性。试验注册号为ISRCTN14411809。
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