Data_Sheet_1_Totally Implantable Venous Access Devices: A Randomized Controlled Trial on the Effect of Psychological Support on Quality of Life and Body Image (BI-PORT).PDF

Background: The presence of totally implantable venous access devices (TIVADs), as any permanent or semipermanent medical devices, has an impact on the quality of life (QoL) of patients. Therefore, the purpose of this trial was to evaluate the efficacy of psychological support for patients undergoing this procedure.
Methods: This randomized controlled trial (RCT) aimed to compare the efficacy of a psychological intervention vs. standard care on QoL in patients receiving TIVAD for chemotherapy treatment (ClinicalTrials.gov NCT02075580). The trial was conducted at the Veneto Institute of Oncology IOV-IRCCS (Padua, Italy) between October 2013 and September 2018. Participants were neoplastic adults receiving TIVAD for chemotherapy treatment for any cancer, not undergoing visible demolitive interventions, without psychopathological diagnosis and language understanding. The exclusion criteria were patients without a diagnosis of cancer, with psychopathological diagnosis, or with language misunderstanding.
Results: The variation of C30-QL2 and BR32-BI was not statistically different between intervention and control arms in men and women. However, the variation of C30-SF was statistically better in the intervention than control arm in men [mean difference (MD) 22.3, 95% CI 3.5 to 41.0] but not in women (MD −2.7, 95% CI −24.0 to 18.7). The variations of the other secondary outcome measures were not statistically different between intervention and control arms.
Conclusion: Psychological support did not show any clear advantages on global QoL and body image perception in patients at 15 days after TIVAD insertion for chemotherapy. In contrast, male patients might benefit from even a very short psychological counseling before or during chemotherapy even if they do not seem to ask for it.

背景：与所有永久性或半永久性医用装置一样，完全植入式静脉输液港（totally implantable venous access devices, TIVADs）的置入会对患者的生活质量（quality of life, QoL）产生影响。因此，本试验旨在评估针对接受该手术患者的心理支持的有效性。
方法：本随机对照试验（randomized controlled trial, RCT）旨在比较心理干预与标准护理对因化疗置入TIVAD的患者的生活质量影响（临床试验注册号：ClinicalTrials.gov NCT02075580）。试验于2013年10月至2018年9月在意大利帕多瓦的威尼托肿瘤研究所IOV-IRCCS开展。纳入标准为：因任何癌症接受化疗并置入TIVAD的成年肿瘤患者，未接受可见切除性手术，无精神病理诊断且具备语言理解能力。排除标准为：未确诊癌症者、存在精神病理诊断者或存在语言理解障碍者。
结果：无论男性还是女性患者，干预组与对照组在C30-QL2及BR32-BI量表得分的变化均无统计学差异。然而，男性患者中干预组的C30-SF量表得分变化显著优于对照组[均数差（mean difference, MD）=22.3，95%置信区间（95% confidence interval, 95% CI）：3.5~41.0]，女性患者中则未观察到该差异（MD=-2.7，95% CI：-24.0~18.7）。其余次要结局指标的得分变化在两组间均无统计学差异。
结论：对于因化疗置入TIVAD后15天的患者，心理支持并未在整体生活质量及身体意象感知方面展现出明确优势。与之相对，尽管男性患者似乎并未主动寻求心理帮助，但他们或许能从化疗前或化疗期间极短时长的心理咨询中获益。