Health-related quality of life in patients with solid tumors receiving implantable venous access ports for chemotherapy: A prospective randomized controlled trial

Purpose: Implantable venous access ports are widely used in patients receiving chemotherapy, but there is still scarce evidence about any patient-reported outcome measures. This prospective randomized controlled trial examined the impact on patients' quality-of-life following the placement of an implantable port device for longterm chemotherapy treatment. Method: A total of 120 chemotherapy naive adult outpatients scheduled to receive chemotherapy (duration >= 12 weeks) for solid tissue tumors in a single academic oncology unit were randomly allocated (n = 60 in each arm) between radiologically guided insertion of an implantable venous access port (PORT arm) or standard repeated peripheral venous access (Control arm). Health-related quality-of-life scores (HRQoL) were assessed with the EQ5D-5L and the oncology-specific EORTC QLQ-C30 (version 3.0) questionnaires at baseline, 3- and 6-months post randomization. Non-parametric tests were applied and differences between medians (Delta) are reported because of skewed-left HRQoL data. Results: Baseline clinical and demographic characteristics were well balanced between the two groups. There were no complications during insertion and no infection or device failure in the PORT subjects through the 6month follow-up. The functional and symptom scales of the EORTC QLQ-C30 questionnaire were similar between both study arms at all time intervals. The EORTC QLQ-C30 global health status was significantly improved in the PORT subjects both at 3 months (Delta: 8.3 out of 100; P = 0.04) and 6 months follow-up (Delta: 16.7 out of 100; P = 0.003). Changes in EQ-5D-5L scores were significantly improved at 6 months in the PORT arm compared to control (Delta: 0.074 out of 1; P = 0.01). Conclusions: Implantable venous access ports may confer significantly improved patient-reported quality-of-life benefits in patients receiving chemotherapy for solid tissue tumors.