Quality of life in patients with liver cancer Cancer Malignant neoplasm of liver and intrahepatic bile ducts
Conditions
Interventions
The intervention will be twice weekly home-based exercise for three months. The follow-up will be complete within 3 months.
The feasibility and acceptability of the intervention and study procedures
Sponsors
Newcastle upon Tyne Hospitals NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 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. 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.. 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. 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
| Measure | Time frame |
|---|---|
| Physical function and self-reported outcomes assessed at baseline and the 10-week follow-up: 1. 5-repetition sit-to-stand (seconds) 2. Isometric handgrip strength (kg) 3. Standing balance in a side-by-side, tandem, and semi-tandem stance (seconds) 4. 4-meter usual gait speed (seconds) 5. Mid-arm circumference (cm) 6. Objectively-measured physical activity over 7 days (accelerometer counts) 7. Functional Assessment of Chronic Illness Therapy - Fatigue (total score) 8. The Functional Assessment of Cancer Therapy – Hepatobiliary (total score) 9. Activities-Specific Balance Confidence Scale (total score) 10. Hospital Anxiety and Depression Scale (total score) 11. Godin leisure-time exercise questionnaire (total leisure activity score) 12. Acceptability will be assessed by brief online surveys to patients within one-hour of their last exercise session in weeks 2, 4, 6, 8, and 10 via Google forms. A link to the survey will be distributed via the chat function in Zoom or via email. The survey will include items related to satisfaction with the technology and exercise sessions, using a Likert-like 5-point scale, as well as an open-ended section. 13. Acceptability will also be assessed qualitatively with in-depth, semi-structured exit interviews using a random sample of at least 10 patients, within 1 - 4 weeks after completion of the final follow-up assessment. | — |
Countries
England, United Kingdom
Outcome results
None listed