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)
Authors: Orange Samuel T , Hallsworth Kate , Brown Morven C. , Reeves Helen L. 
Published: October 2021

Abstract
BackgroundThe 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. MethodsThis is a protocol for a prospective, single-centre, single-arm 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-minutes 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 bi-weekly online surveys and an exit telephone interview. Physical function, accelerometry-measured physical activity, and patient-reported outcome measures (PROMS) will be assessed before and after the intervention. Physical function outcomes include the Short Physical Performance Battery, Liver Frailty Index, and mid-upper arm circumference. 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. DiscussionThis 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