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BACKGROUND: Management of PICC dressing can be performed at home by the patient through adequate training and telenursing. This trial verifies that the incidence of catheter-related complications in home patients, assisted by telenursing, is not greater than that observed in outpatients. METHODS: This clinical trial is composed of 72 patients with malignant tumors who underwent long-term chemotherapy with PICC insertion. They were randomly divided into an experimental group (33 cases) and a calibration group (39 cases). The control group received outpatient dressing for the PICC at the hospital, while the experimental group received a telenursing intervention about the management of the PICC. The incidence of catheter-related infections, the ability of self-management, and a rough cost/benefit estimation were compared between the two groups. This trial was performed according to the CONSORT 2010 checklist. RESULTS: The two groups do not significantly differ in relation to age, sex, and PICCs in terms of the body side insertion, the type of dressing, and the agents used for cleaning. The analysis of the results showed that in the home-managed group, the clinical events reported during the connection were higher when compared with the outpatient group (p < 0.001). The patients in the homecare group developed frequent complications resulting from skin redness (p < 0.001). CONCLUSION: The use of telenursing for patient education in cancer centers can reduce nurses' working time, improving the self-management capacity of patients with a long-term PICC. This trial was retrospectively registered with the Clinical Trial Gov on the 18 May 2023 with registration number NCT05880420.
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Background: Few data are available about the durability of the response, the induction of neutralizing antibodies, and the cellular response upon the third dose of the anti-severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccine in hemato-oncological patients. Objective: To investigate the antibody and cellular response to the BNT162b2 vaccine in patients with hematological malignancy. Methods: We measured SARS-CoV-2 anti-spike antibodies, anti-Omicron neutralizing antibodies, and T-cell responses 1 month after the third dose of vaccine in 93 fragile patients with hematological malignancy (FHM), 51 fragile not oncological subjects (FNO) aged 80-92, and 47 employees of the hospital (healthcare workers, (HW), aged 23-66 years. Blood samples were collected at day 0 (T0), 21 (T1), 35 (T2), 84 (T3), 168 (T4), 351 (T pre-3D), and 381 (T post-3D) after the first dose of vaccine. Serum IgG antibodies against S1/S2 antigens of SARS-CoV-2 spike protein were measured at every time point. Neutralizing antibodies were measured at T2, T3 (anti-Alpha), T4 (anti-Delta), and T post-3D (anti-Omicron). T cell response was assessed at T post-3D. Results: An increase in anti-S1/S2 antigen antibodies compared to T0 was observed in the three groups at T post-3D. After the third vaccine dose, the median antibody level of FHM subjects was higher than after the second dose and above the putative protection threshold, although lower than in the other groups. The neutralizing activity of antibodies against the Omicron variant of the virus was tested at T2 and T post-3D. 42.3% of FHM, 80,0% of FNO, and 90,0% of HW had anti-Omicron neutralizing antibodies at T post-3D. To get more insight into the breadth of antibody responses, we analyzed neutralizing capacity against BA.4/BA.5, BF.7, BQ.1, XBB.1.5 since also for the Omicron variants, different mutations have been reported especially for the spike protein. The memory T-cell response was lower in FHM than in FNO and HW cohorts. Data on breakthrough infections and deaths suggested that the positivity threshold of the test is protective after the third dose of the vaccine in all cohorts. Conclusion: FHM have a relevant response to the BNT162b2 vaccine, with increasing antibody levels after the third dose coupled with, although low, a T-cell response. FHM need repeated vaccine doses to attain a protective immunological response.