Title: Cancer And Venous Access (CAVA) – a randomised controlled trial with associated qualitative research of long term venous access devices for the delivery of chemotherapy: Implantable venous access ports versus tunnelled central lines versus peripheral inserted central catheters.
Funder: Chief Scientist Office, Scotland

Abstract: CAVA is a randomised controlled trial incorporating pre and post trial qualitative research. Prior to the trial commencing, qualitative research will be undertaken to explore the attitudes of clinical staff and patients towards the three venous access devices, to facilitate recruitment to the study. On completion of the trial, qualitative work will be carried out to assess patient and staff acceptability of the three devices. In addition, an economic evaluation will be carried out to evaluate the cost-effectiveness of the three devices. The randomised, controlled trial is of 3 central venous access devices for the delivery of systemic intravenous chemotherapy; subcutaneously tunnelled central lines (Hickman), peripherally inserted central catheters (PICC) and implanted port (Port). There will be 4 randomisation options for each eligible patient: Hickman vs PICC, Hickman vs Port, PICC v Port and Hickman vs PICC vs Port. The trial will take place in six oncology units - the Beatson WoSCC, Queen Elizabeth Hospital, Birmingham, Leeds General Infirmary, The Christie, Manchester, Freeman Hospital, Newcastle and Guy's and St Thomas' Hospital, London.

Lay abstract: When chemotherapy has to be administered by the intravenous route it can either be given through a peripheral cannula into an arm vein or through one of the three central venous access devices: subcutaneously tunnelled central catheters (Hickman type device), peripheral inserted central catheters (PICC) or implantable chest wall ports (Port). Unlike the peripheral cannula these all deliver the drug into a large high flow central vein (superior vena cava), which drains directly into the right atrium of the heart. This avoids local problems from the irritant nature of many chemotherapeutic drugs which damage and rapidly occlude small peripheral arm veins. In addition these three central venous devices are intended to remain in place until the course of treatment has been completed. For patients receiving chemotherapy over several months any one of these devices is regarded as normal practice. The primary objective of the CAVA trial is to compare the clinical and cost effectiveness of three central venous access devices in routine use for the delivery of chemotherapy: PICCs, Hickman type devices and chest wall ports We will do this by running a randomised clinical trial of the three devices in 2000 patients receiving IV anti cancer treatment. The primary endpoint for the randomised study is complication rate, a composite of infection associated with the device (suspected or confirmed) and/or mechanical failure. Secondary outcomes include venous thrombosis (superficial or deep), re-intervention rates (device removal and replacement), interruptions to chemotherapy delivery and quality of life. Health-related quality of life will be measured using the EQ5D and EORTC QLQ-C30 as well as a device-specific quality of life questionnaire.

Research activity codes: 6.3 MEDICAL DEVICES
Health categories: CANCER AND NEOPLASMS