Home based internet supervised exercise for people with liver cancer

Not Applicable

Completed

Conditions: Quality of life in patients with liver cancer
Cancer
Malignant neoplasm of liver and intrahepatic bile ducts

Registration Number: ISRCTN14411809

Lead Sponsor: ewcastle upon Tyne Hospitals NHS Foundation Trust

Brief Summary: 2022 Protocol article in https://pubmed.ncbi.nlm.nih.gov/35624520/ (added 10/05/2023) 2024 Results article in https://pubmed.ncbi.nlm.nih.gov/38866571/ (added 13/06/2024)

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 19

Inclusion Criteria

1. Patients aged =60 years with a clinical diagnosis of HCC
2. Have received NHS standard treatment for HCC (determined by stage of disease), with post-treatment imaging reporting a complete/partial response or stable disease. These will be patients undergoing ‘active monitoring’ with routine scans and outpatient visits every 3-6 months
3. Receiving ongoing care at Newcastle upon Tyne Hospitals NHS Foundation Trust
4. Childs Pugh of B7 or lower (i.e. preserved liver function)
5. WHO performance status 0 or 1 (i.e fit patients)
6. Minimum life expectancy of 6 months
7. Willing and able to give written informed consent

Exclusion Criteria

1. Uncontrolled cardiovascular or metabolic disease
2. Breathlessness at rest or with mild exertion
3. Inability to understand written and verbal instructions in English
4. Physical disability or mental impairment that precludes safe and adequate participation in the study

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Recruitment rate will be recorded as the number of eligible participants who consent to participate in the study within 4 months of it opening<br>2. Retention rate will be recorded as the proportion of patients who complete the study, including attending a follow-up visit 1 month after the exercise intervention ends.<br>3. Intervention adherence will be determined assessing the proportion of exercise sessions attended by patients, as well as assessing the intensity of exercise achieved – using an accelerometer and recorded exercise repetitions..<br>4. Fidelity of the intervention will be assessed by a research team member attending a 10% sample of the virtual sessions, with a checklist to record the expected verses delivered exercise repetitions.<br>5. Safety will be recorded as the number, type, attribution, and severity of adverse events in accordance with Common Terminology for Adverse Events (CTCAE) criteria

Secondary Outcome Measures