Risultati per: Cardio-oncology: rivista open access

Objectives
To explore informal caregivers’ perspectives on precision medicine in cancer care.

Design
Semi-structured interviews with the informal caregivers of people living with cancer and receiving targeted/immunotherapies. Interview transcripts were analysed thematically using a framework approach.

Setting
Recruitment was facilitated by two hospitals and five Australian cancer community groups.

Participants
Informal caregivers (n=28; 16 men, 12 women; aged 18–80) of people living with cancer and receiving targeted/immunotherapies.

Results
Thematic analysis identified three findings, centred largely on the pervasive theme of hope in relation to precision therapies including: (1) precision as a key component of caregivers’ hope; (2) hope as a collective practice between patients, caregivers, clinicians and others, which entailed work and obligation for caregivers; and (3) hope as linked to expectations of further scientific progress, even if there may be no personal, immediate benefit.

Conclusions
Innovation and change in precision oncology are rapidly reconfiguring the parameters of hope for patients and caregivers, creating new and difficult relational moments and experiences in everyday life and in clinical encounters. In the context of a shifting therapeutic landscape, caregivers’ experiences illustrate the need to understand hope as collectively produced, as emotional and moral labour, and as entangled in broader cultural expectations of medical advances. Such understandings may help clinicians as they guide patients and caregivers through the complexities of diagnosis, treatment, emerging evidence and possible futures in the precision era. Developing a better understanding of informal caregivers’ experiences of caring for patients receiving precision therapies is important for improving support to patients and their caregivers.

To the Editor We read with great interest the Original Investigation by Jiang et al, so-called the LASRE randomized clinical trial, demonstrating that laparoscopic surgery provided similar pathologic outcomes compared with open approach for low rectal cancer, with an increased sphincter preservation rate and improved postoperative convalescence. Despite the excellent design and conduct of the trial, we have a few apprehensions to arouse discussions on this flourishing and fadeless research topic.

In Reply We appreciate the comments by Yuan et al regarding our recent Original Investigation. During the surgical operation, we strictly followed the study design of at least 10 cm for proximal resection margin (PRM). The fact that one-fourth of patients in the laparoscopic group had a PRM of 9 cm or less most likely reflects the contraction of resected specimen from the time of resection to the time of measurement (typically at the end of surgery). A similar phenomenon (PRM at

JAMA Oncology is committed to publishing influential original research, opinions, and reviews that advance the science of oncology and improve the clinical care of patients with cancer.

Artificial intelligence (AI) systems—which consist of an AI algorithm and the contexts in which it is deployed—are increasingly obtaining US Food and Drug Administration (FDA) approval and entering the oncology clinic. Artificial intelligence can now assist with fundamental steps of cancer care, including cancer screening, clinical risk prediction, and radiotherapy planning. But especially in early days of implementation, there are risks associated with inappropriate AI use, as well as unknown effects of human factors on system performance in the clinic. Efficiently educating clinicians about AI systems is paramount at this inflection point of AI integration into cancer care.

This past year has been an exciting one for JAMA Oncology and its editors. We have had the pleasure of receiving a substantial number of submissions and reviewing a diverse and interesting array of topics. Diversity in the oncology workforce and disparities in health equity were common topics. Articles ranged from data on lack of access to cancer screening for some populations, to the inability to access health technology, to the role of zip code in cancer care. We continued to receive reports about the COVID-19 pandemic in cancer, including studies that explore the efficacy of specific vaccines on the more aggressive variants of the virus and the role of booster immunizations in enhancing immune responses in patients. We have reported results from several large phase 3 randomized clinical trials affecting standard of care as well as exciting and promising results from smaller phase 1 and 2 studies with outstanding correlative science. We hope that you enjoyed reading these articles as much as we enjoyed choosing the best manuscripts for publication. We thank the many authors, reviewers, and readers for the significant contributions made to the journal this past year. The JAMA Oncology editorial board, editors, and I are honored to have the opportunity to serve the oncology community by offering original, innovative, and timely scientific content that has a direct effect on researchers, clinicians, and the patients we serve. The impact factor of 33.01 placed JAMA Oncology as one of the highest-ranking oncology journals.

The Original Investigation titled “Proton FLASH Radiotherapy for the Treatment of Symptomatic Bone Metastases: the FAST-01 Nonrandomized Trial,” published in the January 2023 issue of JAMA Oncology, has changed license status to open access (CC-BY-NC-ND license). This article was updated online.

Introduction
COVID-19 convalescent plasma (CCP) is a possible treatment option for COVID-19. A comprehensive number of clinical trials on CCP efficacy have already been conducted. However, many aspects of CCP treatment still require investigations: in particular (1) Optimisation of the CCP product, (2) Identification of the patient population in need and most likely to benefit from this treatment approach, (3) Timing of administration and (4) CCP efficacy across viral variants in vivo. We aimed to test whether high-titre CCP, administered early, is efficacious in preventing hospitalisation or death in high-risk patients.

Methods and analysis
COVIC-19 is a multicentre, randomised, open-label, adaptive superiority phase III trial comparing CCP with very high neutralising antibody titre administered within 7 days of symptom onset plus standard of care versus standard of care alone. We will enrol patients in two cohorts of vulnerable patients [(1) elderly 70+ years, or younger with comorbidities; (2) immunocompromised patients]. Up to 1020 participants will be enrolled in each cohort (at least 340 with a sample size re-estimation after reaching 102 patients). The primary endpoint is the proportion of participants with (1) Hospitalisation due to progressive COVID-19, or (2) Who died by day 28 after randomisation. Principal analysis will follow the intention-to-treat principle.

Ethics and dissemination
Ethical approval has been granted by the University of Ulm ethics committee (#41/22) (lead ethics committee for Germany), Comité de protection des personnes Sud-Est I (CPP Sud-Est I) (#2022-A01307-36) (ethics committee for France), and ErasmusMC ethics committee (#MEC-2022-0365) (ethics committee for the Netherlands). Signed informed consent will be obtained from all included patients. The findings will be published in peer-reviewed journals and presented at relevant stakeholder conferences and meetings.

Trial registration
Clinical Trials.gov (NCT05271929), EudraCT (2021-006621-22)

Annals of Internal Medicine, Ahead of Print.

New England Journal of Medicine, Ahead of Print.

Introduction
A major knowledge gap in the treatment of complicated Staphylococcus aureus bacteraemia (SAB) is the optimal duration of antibiotic therapy. Safe shortening of antibiotic therapy has the potential to reduce adverse drug events, length of hospital stay and costs. The objective of the SAFE trial is to evaluate whether 4 weeks of antibiotic therapy is non-inferior to 6 weeks in patients with complicated SAB.

Methods and analysis
The SAFE-trial is a multicentre, non-inferiority, open-label, parallel group, randomised controlled trial evaluating 4 versus 6 weeks of antibiotic therapy for complicated SAB. The study is performed in 15 university hospitals and general hospitals in the Netherlands. Eligible patients are adults with methicillin-susceptible SAB with evidence of deep-seated or metastatic infection and/or predictors of complicated SAB. Only patients with a satisfactory clinical response to initial antibiotic treatment are included. Patients with infected prosthetic material or an undrained abscess of 5 cm or more at day 14 of adequate antibiotic treatment are excluded. Primary outcome is success of therapy after 180 days, a combined endpoint of survival without evidence of microbiologically confirmed disease relapse. Assuming a primary endpoint occurrence of 90% in the 6 weeks group, a non-inferiority margin of 7.5% is used. Enrolment of 396 patients in total is required to demonstrate non-inferiority of shorter antibiotic therapy with a power of 80%. Currently, 152 patients are enrolled in the study.

Ethics and dissemination
This is the first randomised controlled trial evaluating duration of antibiotic therapy for complicated SAB. Non-inferiority of 4 weeks of treatment would allow shortening of treatment duration in selected patients with complicated SAB. This study is approved by the Medical Ethics Committee VUmc (Amsterdam, the Netherlands) and registered under NL8347 (the Netherlands Trial Register). Results of the study will be published in a peer-reviewed journal.

Trial registration number
NL8347 (the Netherlands Trial Register).

Objective
To ascertain how the COVID-19 pandemic was perceived by oncology patients and community health workers (CHWs) and whether this contributed to disruptions in cancer care.

Design
Cross-sectional study using (1) structured telephone interviews with patients and (2) structured questionnaires completed by CHWs.

Setting
Outpatient and community care at Kilimanjaro Christian Medical Centre’s Cancer Care Centre (KCMCCCC), Northern Tanzania.

Participants
300 oncology patients (158 men and 142 women) who had attended KCMCCCC between January and April 2020 and 78 CHWs (16 men and 62 women) in the KCMC regional palliative care network who conducted home visits to patients with cancer during the period January to April 2020.

Primary outcome measures
For patients, missed appointments and fear of COVID-19 more than postponement of their treatment. For CHWs, no primary outcome (a broad range of questions on perception of the pandemic were asked).

Results
30% of patients said they missed appointments due to the pandemic, the most commonly cited reasons being financial problems (37%) and fear of acquiring COVID-19 infection during travel and/or in the hospital (37%). Only 12.7% of patients said they feared COVID-19 more than postponement of cancer treatment. 88% of CHWs noticed differences in delivering home care since the start of the pandemic, with 58% saying they had noticed more patients dying and 74% saying that more patients were relying on local healers. 31% of CHWs said they feared home visits because of COVID-19 and 46% perceived patients feared home visits due to COVID-19. However, 92% felt home visits should continue.

Conclusion
These results indicated that while there was a significant degree of disruption and fear around the COVID-19 pandemic, the majority of patients and CHWs did not fear of COVID-19 more than disruption to cancer care. This highlights the importance to these groups of maintaining access to vital cancer services.

Introduction
Digital patient monitoring (DPM) tools can enable more effective clinical care and improved patient outcomes in cancer. However, their broad adoption requires ease of use and demonstration of real-world clinical utility/impact. ORIGAMA (MO42720) is an interventional, open-label, multicountry platform study investigating the clinical utility of DPM tools and specific treatments. ORIGAMA will begin with two cohorts that aim to assess the impact of the atezolizumab-specific Roche DPM Module (hosted on the Kaiku Health DPM platform (Helsinki, Finland)) on health outcomes and healthcare resource usage, and its feasibility to support at-home treatment administration, in participants receiving systemic anticancer treatment. Other digital health solutions may be added to future cohorts.

Methods and analysis
In Cohort A, participants with metastatic non-small cell lung cancer (NSCLC), extensive-stage SCLC or Child Pugh A unresectable hepatocellular carcinoma will be randomised to a locally approved anticancer regimen containing intravenous atezolizumab (TECENTRIQ, F. Hoffmann-La Roche Ltd/Genentech) and local standard-of-care support, with/without the Roche DPM Module. Cohort B will assess the feasibility of the Roche DPM Module in supporting administration of three cycles of subcutaneous atezolizumab (1875 mg; Day 1 of each 21-day cycle) in the hospital, followed by 13 cycles at home by a healthcare professional (ie, flexible care), in participants with programmed cell-death ligand 1-positive, early-stage NSCLC. The primary endpoints are the mean difference in change of the participant-reported Total Symptom Interference Score at Week 12 from baseline (Cohort A) and flexible care adoption rate at Cycle 6 (Cohort B).

Ethics and dissemination
This study will be conducted according to the Declaration of Helsinki, and/or the applicable laws and regulations of the country in which the research is conducted, whichever affords the greater protection to the individual. The study received its first Ethics Committee approval in Spain in October 2022. Participants will provide written informed consent in a face-to-face setting. The results of this study will be presented at national and/or international congresses and disseminated via publication in peer-reviewed journals.

Trial registration number
NCT05694013.

Si parla di salute nello spazio della Fondazione Burlo Garofolo

Si parla di salute nello spazio della Fondazione Burlo Garofolo

Introduction
It remains uncertain whether the most appropriate management for women with an unfavourable cervix after 24 hours of cervical ripening is repeating the ripening procedure or proceeding directly to induction by oxytocin. No adequately powered trial has compared these strategies. We hypothesise that induction of labour with oxytocin among women who have just undergone an ineffective first ripening procedure is not associated with a higher risk of caesarean delivery than a repeated cervical ripening with prostaglandins.

Methods and analysis
We will conduct a multicentre, non-inferiority, open-label, randomised controlled trial aimed at comparing labour induction by oxytocin with a second cervical ripening that uses prostaglandins (slow-release vaginal dinoprostone; oral misoprostol 25 µg; dinoprostone vaginal gel 2 mg). Women (n=1494) randomised in a 1:1 ratio in 10 French maternity units must be ≥18 years with a singleton fetus in vertex presentation, at a term from ≥37+0 weeks of gestation, and have just completed a 24-hour cervical ripening procedure by any method (pharmacological or mechanical) with a Bishop score ≤6. Exclusion criteria comprise being in labour, having more than 3 contractions per 10 min, or a prior caesarean delivery or a history of uterine surgery, or a fetus with antenatally suspected severe congenital abnormalities or a non-reassuring fetal heart rate. The primary endpoint will be the caesarean delivery rate, regardless of indication. Secondary outcomes concern delivery, perinatal morbidity, maternal satisfaction and health economic evaluations. The nature of the assessed procedures prevents masking the study investigators and patients to group assignment.

Ethics and dissemination
All participants will provide written informed consent. The ethics committee ‘Comité de Protection des Personnes Ile de France VII’ approved this study on 2 April 2021 (No 2021-000989-15). Study findings will be submitted for publication and presented at relevant conferences.

Trial registration number
NCT04949633.