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23 result(s) for "Parente, Phillip"
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Telerehabilitation’s Safety, Feasibility, and Exercise Uptake in Cancer Survivors: Process Evaluation
Access to exercise for cancer survivors is poor despite global recognition of its benefits. Telerehabilitation may overcome barriers to exercise for cancer survivors but is not routinely offered. Following the rapid implementation of an exercise-based telerehabilitation program in response to COVID-19, a process evaluation was conducted to understand the impact on patients, staff, and the health service with the aim of informing future program development. A mixed methods evaluation was completed for a telerehabilitation program for cancer survivors admitted between March and December 2020. Interviews were conducted with patients and staff involved in implementation. Routinely collected hospital data (adverse events, referrals, admissions, wait time, attendance, physical activity, and quality of life) were also assessed. Patients received an 8-week telerehabilitation intervention including one-on-one health coaching via telehealth, online group exercise and education, information portal, and home exercise prescription. Quantitative data were reported descriptively, and qualitative interview data were coded and mapped to the Proctor model for implementation research. The telerehabilitation program received 175 new referrals over 8 months. Of those eligible, 123 of 150 (82%) commenced the study. There were no major adverse events. Adherence to health coaching was high (674/843, 80% of scheduled sessions), but participation in online group exercise classes was low (n=36, 29%). Patients improved their self-reported physical activity levels by a median of 110 minutes per week (IQR 90-401) by program completion. Patients were satisfied with telerehabilitation, but clinicians reported a mixed experience of pride in rapid care delivery contrasting with loss of personal connections. The average health service cost per patient was Aus $1104 (US $790). Telerehabilitation is safe, feasible, and improved outcomes for cancer survivors. Learnings from this study may inform the ongoing implementation of cancer telerehabilitation.
From Hypoglycaemia to Haemorrhage: A Case of Giant Pleural Solitary Fibrous Tumour With Doege–Potter Syndrome
Doege–Potter Syndrome (DPS) is a rare paraneoplastic cause of hypoglycaemia, arising from solitary fibrous tumours (SFTs) that ectopically secrete insulin‐like growth factor II (IGF‐II). We report a case of DPS in a 76‐year‐old man presenting with recurrent severe hypoglycaemia. Biochemistry investigations revealed hypoglycaemia with suppressed insulin, C‐peptide and beta‐hydroxybutyrate levels. Magnetic resonance imaging (MRI) confirmed a giant (205 × 190 × 169 mm) right pleurally‐based SFT. Hypoglycaemia was managed with intravenous dextrose infusion and glucagon until surgical resection via thoracotomy. A massive transfusion protocol was activated for intra‐operative bleeding. Histopathology confirmed a spindle cell SFT without malignant features. Post‐operative blood glucose levels normalised, and the patient was discharged without complication. This case highlights the diagnostic challenges of DPS, the potential to maintain pre‐operative normoglycaemia without glucocorticoid therapy and the importance of recognising tumour vascularity to guide pre‐operative planning and reduce bleeding risk. We describe a case of Doege–Potter syndrome from a giant pleural solitary fibrous tumour in a 76‐year‐old male. This case highlights the potential for maintaining pre‐operative normoglycaemia without glucocorticoids and emphasises recognising tumour vascularity on imaging to anticipate intra‐operative bleeding risk.
Health care resource use among patients with advanced non-small cell lung cancer: the PIvOTAL retrospective observational study
Background Data are scarce regarding real-world health care resource use (HCRU) for non-small cell lung cancer (NSCLC). An understanding of current clinical practices and HCRU is needed to provide a benchmark for rapidly evolving NSCLC management recommendations and therapeutic options. The objective of this study was to describe real-world HCRU for patients with advanced NSCLC. Methods This multinational, retrospective chart review study was conducted at academic and community oncology sites in Italy, Spain, Germany, Australia, Japan, South Korea, Taiwan, and Brazil. Deidentified data were drawn from medical records of 1440 adults (≥18 years old) who initiated systemic therapy (2011 to mid-2013) for a new, confirmed diagnosis of advanced or metastatic (stage IIIB or IV) NSCLC. We summarized HCRU associated with first and subsequent lines of systemic therapy for advanced/metastatic NSCLC. Results The proportion of patients who were hospitalized at least once varied by country from 24% in Italy to 81% in Japan during first-line therapy and from 22% in Italy to 84% in Japan during second-line therapy; overall hospitalization frequency was 2.5–11.1 per 100 patient-weeks, depending on country. Emergency visit frequency also varied among countries (overall from 0.3–5.9 per 100 patient-weeks), increasing consistently from first- through third-line therapy in each country. The outpatient setting was the most common setting of resource use. Most patients in the study had multiple outpatient visits in association with each line of therapy (overall from 21.1 to 59.0 outpatient visits per 100 patient-weeks, depending on country). The use of health care resources showed no regular pattern associated with results of tests for activating mutations of the epidermal growth factor receptor ( EGFR ) gene or anaplastic lymphoma kinase ( ALK ) gene rearrangements. Conclusions HCRU varied across countries. These findings suggest differing approaches to the clinical management of advanced NSCLC among the eight countries. Comparative findings and an understanding of country-specific clinical practices can help to identify areas of need and guide future resource allocation for patients with advanced NSCLC. Further studies evaluating the costs associated with resource use are warranted.
Clinical factors influencing retreatment with anti-PD-(L)1 therapies after treatment in early-stage cancers: a modified Delphi consensus study
Anti-programmed death (ligand) 1 (anti-PD-(L)1) therapies were first introduced in the metastatic setting and have since been approved and reimbursed for treating early-stage cancers in the adjuvant, perioperative, and neoadjuvant settings in many cancer types. Current evidence supporting anti-PD(L)-1 retreatment after relapse with prior neoadjuvant and/or adjuvant anti-PD(L)1 therapy is limited and inconclusive. There is no guidance for clinicians on how and when to retreat with anti-PD-(L)1 therapies when anti-PD-(L)1 therapy was administered in the neoadjuvant and/or adjuvant setting. This study aimed to reach consensus on factors to guide decision-making regarding retreatment with anti-PD-(L)1 therapies after prior therapy with an anti-PD-(L)1 agent. This modified Delphi study consisted of a clinician survey across 10 countries followed by three real-time virtual Delphi panels involving clinical experts who had completed the survey. Clinical experts were experienced in using anti-PD-(L)1 treatments in early-stage cancers and/or as retreatment of patients with recurrences following early-stage treatment with anti-PD-(L)1 therapies. Of 28 clinicians providing survey responses, 20 participated in one of three Delphi panels. There was consensus that retreatment can be defined as ‘repeated treatment with the same therapeutic class following relapse after or during neoadjuvant and/or adjuvant treatment.’ All three panels agreed that decisions around retreatment should consider ‘prior immune-related adverse events/toxicity,’ ‘time-related factors’ (eg, time since completion of full treatment course and since discontinuation) and ‘previous patient response’ (often referred to by clinicians as tumor response, which may have reflected their experience with metastatic disease). Other factors identified as important included country-specific practices, treatment availability, and reimbursement. Generally, the clinical experts considered that retreatment could be considered from ≥3 to 6 months after stopping initial anti-PD-(L)1 treatment, or from ≥6 months after relapse/recurrence. In conclusion, clinicians across different regions recognized a role for retreating patients with anti-PD-(L)1 therapies after initial anti-PD-(L)1 treatment for early-stage cancers. Consensus was reached on some factors to consider regarding whether and when to retreat, although differences in clinical practice between countries/geographical regions made it difficult to achieve consensus for some more nuanced elements of retreatment. Further evidence could help better inform retreatment decisions.
Efficacy of Group Exercise–Based Cancer Rehabilitation Delivered via Telehealth (TeleCaRe): Protocol for a Randomized Controlled Trial
Access to rehabilitation to support cancer survivors to exercise is poor. Group exercise-based rehabilitation may be delivered remotely, but no trials have currently evaluated their efficacy. We aimed to evaluate the efficacy of a group exercise-based cancer rehabilitation program delivered via telehealth compared to usual care for improving the quality of life of cancer survivors. A parallel, assessor-blinded, pragmatic randomized controlled trial with embedded cost and qualitative analysis will be completed. In total, 116 cancer survivors will be recruited from a metropolitan health network in Melbourne, Victoria, Australia. The experimental group will attend an 8-week, twice-weekly, 60-minute exercise group session supervised via videoconferencing supplemented by a web-based home exercise program and information portal. The comparison group will receive usual care including standardized exercise advice and written information. Assessments will be completed at weeks 0 (baseline), 9 (post intervention), and 26 (follow-up). The primary outcome will be health-related quality of life measured using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire at week 9. Secondary measures include walking capacity (6-minute walk test), physical activity (activPAL accelerometer), self-efficacy (Health Action Process Approach Questionnaire), and adverse events. Health service data including hospital length of stay, hospital readmissions, and emergency department presentations will be recorded. Semistructured interviews will be completed within an interpretive description framework to explore the patient experience. The primary outcome will be analyzed using linear mixed effects models. A cost-effectiveness analysis will also be performed. The trial commenced in April 2022. As of June 2022, we enrolled 14 participants. This trial will inform the future implementation of cancer rehabilitation by providing important data about efficacy, safety, cost, and patient experience. Australian New Zealand Clinical Trials Registry ACTRN12621001417875; https://tinyurl.com/yc5crwtr. PRR1-10.2196/38553.
Real‐world first‐line systemic therapy patterns in metastatic castration‐resistant prostate cancer
Introduction Several systemic therapies have demonstrated a survival advantage in metastatic castration resistant prostate cancer (mCRPC). Access to these medications varies significantly worldwide. In Australia until recently, patients must have received docetaxel first, unless unsuitable for chemotherapy, despite no evidence suggesting superiority over androgen receptor signalling inhibitors (ARSIs). Our study investigated real‐world systemic treatment patterns in Australian patients with mCRPC. Methods The electronic CRPC Australian Database (ePAD) was interrogated to identify mCRPC patients. Clinicopathological features, treatment and outcome data, stratified by first‐line systemic therapies, were extracted. Comparisons between groups utilised Kruskal–Wallis tests and Chi‐Square analyses. Time‐to‐event data were calculated using Kaplan–Meier methods and groups compared using log‐rank tests. Factors influencing overall survival (OS) and time to treatment failure (TTF) were analysed through Cox proportional hazards regression models. Results We identified 578 patients who received first‐line systemic therapy for mCRPC. Enzalutamide (ENZ) was most commonly prescribed (n = 240, 41%), followed by docetaxel (DOC, n = 164, 28%) and abiraterone (AA, n = 100, 17%). Patients receiving ENZ or AA were older (79, 78.5 years respectively) compared with DOC (71 years, p = 0.001) and less likely to have ECOG performance status 0 (45%, 44%, 59% in ENZ, AA and DOC groups respectively p < 0.0001). Median TTF was significantly higher in those receiving ENZ (12.4 months) and AA (11.9 months) compared to DOC (8.3 months, p < 0.001). PSA50 response rates and OS were not statistically different. Time to developing CRPC > 12 months was independently associated with longer TTF (HR 0.67, p < 0.001) and OS (HR 0.49, p = 0.002). Conclusion In our real‐world population, ENZ and AA were common first‐line systemic therapy choices, particularly among older patients and those with poorer performance status. Patients receiving ENZ and AA demonstrated superior TTF compared to DOC, while OS was not statistically different. Our findings highlight the important role of ARSIs, given the variability of access worldwide.
Outcomes of a randomized controlled trial assessing a smartphone Application to reduce unmet needs among people diagnosed with CancEr (ACE)
Background Smartphone technology represents an opportunity to deliver practical solutions for people affected by cancer at a scale that was previously unimaginable, such as information, appointment monitoring, and improved access to cancer support services. This study aimed to determine whether a smartphone application (app) reduced the unmet needs among people newly diagnosed with cancer. Methods A single blind, multisite randomized controlled trial to determine the impact of an app‐based, 4‐month intervention. Newly diagnosed cancer patients were approached at three health service treatment clinics. Results Eighty‐two people were randomized (intervention; n = 43 and control; n = 39), average age was 59.5 years (SD: 12.9); 71% female; 67% married or in a de facto relationship. At baseline, there were no differences in participants’ characteristics between the groups. No significant effects, in reducing unmet needs, were demonstrated at the end of intervention (4‐month) or 12‐month follow‐up. Overall, 94% used the app in weeks 1‐4, which decreased to 41% in weeks 13‐16. Mean app use time per participant: Cancer Information, 6.9 (SD: 18.9) minutes; Appointment Schedule, 5.1 (SD: 9.6) minutes; Cancer Services 1.5 minutes (SD: 6.8); Hospital Navigation, 1.4 (SD: 2.8) minutes. Conclusions Despite consumer involvement in the design of this smartphone technology, the app did not reduce unmet needs. This may have been due to the study being underpowered. To contribute to a meaningful understanding and improved implementation of smartphone technology to support people affected by cancer, practical considerations, such as recruitment issues and access to, and confidence with, apps, need to be considered. Australian New Zealand Clinical Trials Registration (ACTRN) Trial Registration: 12616001251415; WEF 7/9/2016. Smartphone technology represents an opportunity to deliver practical solutions for people affected by cancer at a scale that was previously unimaginable, such as information, and improved access to cancer support services.
Immunodominant CD4+Responses Identified in a Patient Vaccinated with Full-Length NY-ESO-1 Formulated with ISCOMATRIX Adjuvant
There is increasing evidence showing the involvement of CD4+T cells in initiating and maintaining antitumor immune responses. NY-ESO-1 is expressed by various tumors but not normal tissues except testis. We conducted a cancer clinical trial by using full-length NY-ESO-1 protein formulated with ISCOMATRIX adjuvant and injected into patients intramuscularly. Autologous dendritic cells pulsed with NY-ESO-1 ISCOMATRIX in combination with overlapping synthetic peptides were used to identify immunodominant T cells from a vaccinated patient. We show here the identification and characterization of two novel CD4+T cell epitopes. T cells specific to these epitopes not only recognized autologous dendritic cells loaded with NY-ESO-1 but also NY-ESO-1-expressing tumor cell lines treated with IFN-γ. One of the two responses identified was greater than the previously identified immunodominant HLA-DPA-restricted response and correlated with NY-ESO-1-specific CD8+T cell induction after vaccination. This T cell response was vaccinated in most patients who expressed HLA-DR2. This study has systematically surveyed patients vaccinated with full-length tumor antigen for a vaccinated CD4 helper T cell response.
Does implementation matter if comprehension is lacking? A qualitative investigation into perceptions of advance care planning in people with cancer
PurposeWhile advance care planning holds promise, uptake is variable and it is unclear how well people engage with or comprehend advance care planning. The objective of this study was to explore how people with cancer comprehended advance care plans and examine how accurately advance care planning documentation represented patient wishes.MethodsThis study used a qualitative descriptive design. Data collection comprised interviews and an examination of participants’ existing advance care planning documentation. Participants included those who had any diagnosis of cancer with an advance care plan recorded: Refusal of Treatment Certificate, Statement of Choices, and/or Enduring Power of Attorney (Medical Treatment) at one cancer treatment centre.ResultsFourteen participants were involved in the study. Twelve participants were female (86%). The mean age was 77 (range: 61–91), and participants had completed their advance care planning documentation between 8 and 72 weeks prior to the interview (mean 33 weeks). Three themes were evident from the data: incomplete advance care planning understanding and confidence, limited congruence for attitude and documentation, advance care planning can enable peace of mind. Complete advance care planning understanding was unusual; most participants demonstrated partial comprehension of their own advance care plan, and some indicated very limited understanding. Participants’ attitudes and their written document congruence were limited, but advance care planning was seen as helpful.ConclusionsThis study highlighted advance care planning was not a completely accurate representation of patient wishes. There is opportunity to improve how patients comprehend their own advance care planning documentation.