No impact of central venous insertion site on oncology patients’ quality of life and psychological distress. A randomized three-arm trial
- 327 Downloads
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).
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.
Central venous insertion sites had no impact on patients’ QoL and psychological distress. Patients undergoing palliative therapies showed worse EORTC QLQ-C30 scales.
KeywordsTIAP implantation site QoL HADS Chemotherapy
The Authors gratefully thank Katia Lorizzo, MD, Sabine Cenciarelli, MD, Emilio Bertani, MD for their support in patients’ accrual, Mrs. Adriana Barioli for her technical assistance, Mara Ghioni, MSc and Rosalba Lembo, MSc-PhD for data management.
Bard Italia – Rome offered technical support for this study.
Conflicts of interest
- 10.Al-Sunduqchi Mahdi S (1990). Determining the appropriate sample size for inferences based on the Wilcoxon statistics. Ph.D. dissertation under the direction of William C. Guenther, Dept. Of Statistics, University of Wyoming, Laramie, WYGoogle Scholar
- 11.Fayers PM, Aaronson NK, Bjordal K, Groenvold M, Curran D, Bottomley A (2001) EORTC QLQ-C30 scoring manual, 3rd edn. European Organization for Research and Treatment of Cancer, BrusselsGoogle Scholar
- 12.Osoba D, Bezjak A, Brundage M (2005) for the Quality of Life committee of the NCIC CTG. Analysis and interpretation of health-related quality of life data from clinical trials: basic approach of the National Cancer Institute of Canada Clinical Trials Group. Eur J Cancer 41:280–287PubMedCrossRefGoogle Scholar
- 17.Chenecky C (2001) Satisfaction versus dissatisfaction with venous access devices in outpatient oncology: a pilot study. Oncol Nurs Forum 28:1613–1616Google Scholar
- 18.Ng F, Mastoroudes H, Paul E et al (2007) A comparison of Hickman line and Port-a-Cath associated complications in patients with solid tumours undergoing chemotherapy. Clin Oncol (R Coll Radiol) 19:551–556Google Scholar
- 31.Bow EJ, Kilpatrick MG, Clinch JJ (1999) Totally implantable venous access ports systems for patients receiving chemotherapy for solid tissue malignancies: a randomized controlled clinical trial examining the safety, efficacy, costs, and impact on quality of life. J Clin Oncol 17:1267–1273PubMedGoogle Scholar