Venous Access in Cancer Patients Cancer Venous Access in Cancer Patients
Conditions
Interventions
All patients will receive either a Port, PICC or Hickman Type device. There are four possible randomisation options for each patient. The site or patient will chose which randomisation option to be
Sponsors
NHS Greater Glasgow and Clyde (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged = 18 years 2. Receiving or to receive chemotherapy 3.Duration of chemotherapy = 12 weeks 4. Clinical team uncertain as to which device is optimal for this indication 5. Solid or haematological malignancy 6. Suitable upper extremity vein for all the access devices to which the patient may be randomised 7. Able to provide written informed consent
Exclusion criteria
Exclusion criteria: 1. Life or treatment expectancy <3 months 2.Previous venous access device removed due to complication within last three months 3. Requirement for high volume (apheresis) line 4. Need for catheter to be placed in a non upper extremity vein 5. Patient previously randomised into the CAVA tria
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome for the randomised trial is complication rate, a composite of infection (suspected or confirmed) and/or mechanical failure. This will be analysed using logistic regression including terms for treatment group and randomisation stratification factors. | — |
Secondary
| Measure | Time frame |
|---|---|
| An analysis will also be conducted based on complication event rate data 13. This analysis will estimate the effect of the access devices on the individual component complications (infections and mechanical failure) and will allow an assessment of the similarity of these effects via a likelihood ratio test. The incidence of venous thrombosis will be compared using logistic regression and also as an event rate. The frequency of the various complications will be assessed. The total duration of treatment interruptions will be summarised and compared using a Mann Whitney U-test. Scores for the five dimensions of the EQ-5D (mobility, self-care, usual activities, pain/discomfort and anxiety/depression) and the visual analogue score for health will be summarised and the EQ-5D curves will be compared between treatment groups using an area under curve (AUC) approach standardised for the period on study and using the baseline value as a covariate. Scores for the 5 functional scales (physical, role, emotional, cognitive, social) and 9 symptom scales (fatigue, nausea and vomiting, pain, dyspnoea, insomnia, appetite loss, constipation, diarrhoea, financial difficulties) of the EORTC QLQ-C30 will be calculated according to standard EORTC conventions, as will global health status score. These scores will be summarised and analysed as EQ-5D. The results from the device-specific questionnaire will be summarised only. | — |
Countries
Scotland, United Kingdom
Outcome results
None listed