No impact of central venous insertion site on oncology patients' quality of life and psychological distress. A randomized three-arm trial.

PURPOSE: Though totally implantable access ports (TIAP) are extensively used, information from randomized trials about the impact of insertion site on patient's quality of life (QoL) and psychological distress is unavailable. PATIENTS AND METHODS: Four hundred and three patients eligible for receiving intravenous chemotherapy for solid tumours were randomly assigned to implantation of a single type of TIAP, either through a percutaneous landmark access to the internal jugular or an ultrasound-guided access to the subclavian or a surgical cut-down access through the cephalic vein at the deltoid-pectoralis groove. Patients' QoL and psychological distress were investigated at regular intervals by means of EORTC QLQ-C30 and HADS (Hospital Anxiety and Depression Scale) questionnaires, using univariate and multivariate repeated measure linear mixed models. A post hoc analysis investigated the impact of type of administered chemotherapy (adjuvant vs palliative).
RESULTS: Three hundred and eighty-four patients (95.2%) were evaluable, 126 with the internal jugular, 132 with the subclavian and 126 with the cephalic vein access. The median follow-up was 361 days (range, 0-1,087). Mean score changes for the items of the EORTC QLQ-C30 scales were significantly associated with type of administered chemotherapy only (P < 0.001), and not with implantation site. Frequency distribution of patients with depression and anxiety score greater than 10 at HADS was not significantly different, with respect either to type of administered chemotherapy or TIAP implantation site.
CONCLUSION: Central venous insertion sites had no impact on patients' QoL and psychological distress. Patients undergoing palliative therapies showed worse EORTC QLQ-C30 scales.

RCT Entities:   Population Interventions Outcomes