A prospective study investigating the efficacy and toxicity of definitive ChemoRadiation and ImmunOtherapy (CRIO) in locally and/or regionally advanced unresectable cutaneous squamous cell carcinoma.

BACKGROUND: Patients with unresectable advanced cutaneous squamous cell carcinoma (cSCC) are generally treated with palliative intent. Immune checkpoint blockade has significant activity in the palliative setting in patients with recurrent or metastatic cSCC. This single arm phase 2 prospective study aims to investigate the combination of curative intent chemoradiation and durvalumab (anti-PD-L1 checkpoint inhibitor) for this patient cohort. METHODS: Patients with unresectable locally and or regionally advanced pathologically confirmed cSCC (stage III-IVa) deemed fit for CRIO by consensus of the Multidisciplinary meeting will be eligible. In the first stage of a two-stage minimax design, we aim to recruit a total of 15 patients. If fewer than 7 patients achieved a complete response in the first stage, we will conclude the treatment is not more effective than standard treatment. The co-primary endpoints of CRIO are the safety of treatment (acute and late toxicities) and the rate of complete response. Secondary endpoints would include overall survival, progression free survival, and locoregional control. Translational research endpoints including biomarkers (CD73, CD39, PD-1, PD-L1) will also be explored utilising multiplex immunohistochemistry on tumour biopsy samples obtained prior to commencing treatment and during treatment (week 2). In addition, the utility of CXCR-4 PET/CT scan will be explored. DISCUSSION: CRIO is a novel trial evaluating the combination of curative intent chemoradiotherapy with concurrent and adjuvant durvalumab for patients with unresectable stage III-IVa cSCC. TRIAL REGISTRATION: Trial registered with the Australian New Zealand Clinical Trial Registry (ACTRN12618001573246).

Toward structured peer support interventions in oncology: a qualitative insight into the experiences of gynaecological cancer survivors providing peer support.

PURPOSE: Research into dyadic (one-to-one) peer support has predominantly focused on the recipients of peer support whilst neglecting the impact on the peer support providers (PSPs). Increasingly, structured/protocolised peer support interventions are employed. The aim of this qualitative study was to explore the experience of providing peer support within a protocolised intervention and how common key characteristics of such interventions (guidelines and checklists, rigorous training and partnerships with health professionals) may influence PSPs' experiences. This research was conducted within the context of an ongoing randomised controlled trial investigating a protocolised peer support intervention (the Peer and Nurse support Trial to Assist women in Gynaecological Oncology (PeNTAGOn) study). METHODS: Eleven women (gynaecological cancer survivors) providing peer support within the PeNTAGOn study participated in semi-structured telephone interviews. Transcribed interviews were analysed using interpretative phenomenological analysis. RESULTS: Five key themes were identified which described the overall experience of providing protocolised peer support: (i) fitting oneself to the protocolised PSP role, (ii) the impact of personal beliefs about the value of research, (iii) protocolisation as both blessing and curse, (iv) discussing taboo or sensitive topics and (v) the impact of interactions with study personnel. CONCLUSIONS: These insights into the advantages and disadvantages of protocolised peer support can be used to inform future research and social support programs and maximise the effectiveness of such programs for patients, PSPs and the health-care system.

Verification of resident bedside-procedure competency by intensive care nursing staff.

BACKGROUND: Recent efforts by the Accreditation Council for Graduate Medical Education to standardize resident education and demonstrate objective clinical proficiency have led toward more accurate documentation of resident competencies. Particularly with regard to bedside procedures, hospitals are now requiring certification of competency before allowing a provider to perform them independently. The current system at our institution uses a time-consuming, online verification system. This study provided an alternative method through an identification card with a list of bedside procedures. Our aim was an easier verification method for nurses, allowing fewer delays of bedside procedures and more time for nursing to patient care. METHODS: We performed a prospective, controlled study, using general surgical residents and surgical intensive care nurses. Subjects performed an initial survey of their experience with the current online system in place to identify resident bedside procedure competency. Phase I involved educating the subjects about this current system followed by another survey. Phase II involved introducing our proficiency card. After 3 months, we conducted a final survey to evaluate opinions on the proficiency card, comparing it with the online verification method. RESULTS: Nursing postintervention responses indicated that significantly less time was required to validate a resident's proficiency (P = .04). Prior to the introduction of the proficiency card, only 15% of nurses reported a verification time of 5 minutes or less, compared with 64% postintervention. In addition, nurses rated the card validation as an easier, more efficient method of verification (P = .02). CONCLUSIONS: We believe that its continued use will not only improve the adherence to a mandatory hospital policy but also result in a less-cumbersome verification process, allowing more time for physician and nurse-to-patient care.