294 results match your criteria: "Clinical Trials and Statistics Unit[Affiliation]"

Occupational therapy improves social participation of complex patients discharged from hospital: results of a powered randomized controlled trial.

Disabil Rehabil

June 2024

Medical Doctor, Physical Medicine and Rehabilitation Unit, Azienda Unità Sanitaria Locale-IRCCS di Reggio Emilia, Reggio Emilia, Italy.

Purpose: To verify the effectiveness of experimental occupational therapy plus intensive standard rehabilitation compared to intensive standard rehabilitation alone on the reintegration to social activities of complex patients three months after hospital discharge.

Materials And Methods: Patients with a score ≥ 9 on the Rehabilitation Complexity Scale at admission to an intensive rehabilitation ward were randomized to the control or experimental group. Both groups received intensive multidisciplinary rehabilitation aimed at recovering independence in the basic activities of daily life (ADL).

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Article Synopsis
  • Adding concurrent chemotherapy to radiotherapy enhances treatment outcomes for patients with muscle-invasive bladder cancer, with a meta-analysis indicating better disease control with a hypofractionated schedule.
  • The RAIDER clinical trial compared standard and adaptive radiotherapy in patients with unifocal bladder cancer, assessing acute toxicity based on therapy and fractionation schedules.
  • Results showed that individuals receiving concomitant therapy experienced significantly higher rates of acute grade 2+ gastrointestinal toxicity in the 20-fraction group, but not in the 32-fraction group, highlighting differences in toxicity based on treatment regimens.
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Ruxolitinib Versus Best Available Therapy for Polycythemia Vera Intolerant or Resistant to Hydroxycarbamide in a Randomized Trial.

J Clin Oncol

July 2023

Medical Research Council (MRC) Molecular Haematology Unit, MRC Weatherall Institute of Molecular Medicine, NIHR, Biomedical Research Centre, University of Oxford, Oxford, United Kingdom.

Article Synopsis
  • Polycythemia vera (PV) is a blood disorder linked to JAK/STAT activation, and ruxolitinib has been shown to effectively manage high-risk patients by controlling blood counts and alleviating symptoms.
  • The MAJIC-PV trial compared ruxolitinib to best available therapy (BAT) in patients who were resistant or intolerant to hydroxycarbamide, with the main goal of achieving a complete response (CR) within a year.
  • Results showed that ruxolitinib led to a significantly higher CR rate (43% vs. 26% for BAT), better duration of response and symptom improvement, and a stronger correlation between molecular response and patient outcomes like event-free survival (
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Hypofractionation: The standard for external beam breast irradiation.

Breast

June 2023

Clinical Trials and Statistics Unit (ICR-CTSU), The Institute of Cancer Research, Sutton, London, UK. Electronic address:

This overview provides the historical perspective of external beam breast hypofractionation over the last 50 years. It highlights the serious harm suffered by patients with breast cancer in the 1970's and 1980's because of new hypofractionation regimens based on a theoretical radiobiology model being adopted into clinical practice to solve a resource issue without testing within clinical trials and without the essential radiotherapy quality assurance. It then describes the high-quality clinical trials comparing 3-week with 5-week standard of care regimens that were initiated based on a strong scientific rationale for hypofractionation in breast cancer.

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Background: Health information concerns both individuals' engagement and the way services and professionals provide information to facilitate consumers' health decision making. Citizens' and patients' participation in the management of their own health is related to the availability of tools making health information accessible, thus promoting empowerment and making care more inclusive and fairer. A novel instrument was developed (Evaluation Tool of Health Information for Consumers-ETHIC) for assessing the formal quality of health information materials written in Italian language.

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Purpose: Ki67 assessed at diagnosis (Ki67) is an important prognostic factor in primary oestrogen receptor-positive (ER +) breast cancer. Proportional change in Ki67 after 2 weeks (∆Ki67) is associated with clinical benefit from endocrine therapies and residual Ki67 (Ki67) with recurrence-free survival. The aim was to define the association between Ki67 and after aromatase inhibitor (AI) exposure ∆Ki67 and Ki67 with key prognostic and biologic factors utilising data from the POETIC study.

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Hospice Patients' End-of-Life Dreams and Visions: A Systematic Review of Qualitative Studies.

Am J Hosp Palliat Care

January 2024

Qualitative Research Unit, Azienda USL-IRCCS di Reggio Emilia, Reggio Emilia, Italy.

When conscious, about 50% to 60% of hospice patients report a "visitation" by someone who is not there while they dream or are awake: a phenomenon known as End-of-Life Dreams and Visions (ELDVs). Since the dying process is frequently complicated by delirium, ELDVs risk being misidentified as such by professionals and caregivers. To observe these phenomena from patients' perspectives, we conducted a systematic review to aggregate and synthesize the findings from the qualitative studies about ELDVs of patients assisted in hospices to indicate future directions for research and care.

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Aims: To evaluate whether there is sufficient correlation between patient-reported outcomes (PROs) and clinician-reported outcomes (CROs) in bladder cancer follow-up post-radiotherapy to streamline data collection and to reduce trial follow-up burden on patients, clinicians and trial programmes.

Materials And Methods: PROs data were collected within the BC2001 trial using the Functional Assessment of Cancer Therapy specific to bladder cancer (FACT-BL) questionnaire. CROs data were collected by clinicians using Late Effects in Normal Tissues Subjective, Objective and Management (LENT/SOM).

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Patterns of utilisation of specialist care after SARS-Cov-2 infection: a retrospective cohort study.

BMJ Open

March 2023

Health Services Research, Evaluation and Policy Unit, Azienda USL della Romagna, Ravenna, Italy.

Objective: To explore the pattern of health services utilisation of people who had had a documented SARS-Cov-2 infection.

Design: Retrospective cohort study.

Setting: The Italian province of Reggio Emilia.

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First-in-human technique translation of oxygen-enhanced MRI to an MR Linac system in patients with head and neck cancer.

Radiother Oncol

June 2023

Division of Cancer Sciences, University of Manchester, Manchester, UK; Radiology, The Christie NHS Foundation Trust, Manchester, UK; Division of Radiotherapy and Imaging, The Institute of Cancer Research, London, UK.

Background And Purpose: Tumour hypoxia is prognostic in head and neck cancer (HNC), associated with poor loco-regional control, poor survival and treatment resistance. The advent of hybrid MRI - radiotherapy linear accelerator or 'MR Linac' systems - could permit imaging for treatment adaptation based on hypoxic status. We sought to develop oxygen-enhanced MRI (OE-MRI) in HNC and translate the technique onto an MR Linac system.

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Objectives: There is a global increase in the number of women diagnosed with cancer during their pregnancy and a nascent evidence base to guide their supportive care. The purposes of this study were to (1) map research on the psychosocial issues affecting women and their partners on diagnosis and treatment for cancer during pregnancy; (2) determine available supportive care or educational interventions; and (3) identify knowledge gaps for future research and development.

Design: Scoping review.

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Several studies have demonstrated the association between acute and late radiotherapy toxicity in prostate cancer using older radiotherapy techniques. However, whether this association is present with newer techniques such as stereotactic body radiotherapy (SBRT), remains unclear. We use univariable and multivariable logistic regression to analyse the association between grade 2 or worse acute gastrointestinal (GI) and genitourinary (GU) toxicities with equivalent late toxicities in patients treated with SBRT and conventional or moderately fractionated radiotherapy (CRT) within the PACE-B study.

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Purpose: The CHHiP trial assessed moderately hypofractionated radiation therapy in localized prostate cancer. We utilized longitudinal prostate-specific antigen (PSA) measurements collected over time to evaluate and characterize patient prognosis.

Methods And Materials: We developed a clinical dynamic prediction joint model to predict the risk of biochemical or clinical recurrence.

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Patterns of Failure After Stereotactic Body Radiotherapy to Sacral Metastases.

Clin Oncol (R Coll Radiol)

May 2023

The Royal Marsden NHS Foundation Trust, Sutton, UK; Radiotherapy and Imaging Division, Institute of Cancer Research, London, UK.

Aims: Stereotactic body radiotherapy (SBRT) is increasingly used to treat sacral metastases. We analysed our centre's local relapse rates and patterns of failure after sacral SBRT and assessed whether using the consensus contouring recommendation (CCR) may have prevented local relapse.

Materials And Methods: We conducted a single-centre retrospective review of patients treated with sacral SBRT between February 2012 and December 2021.

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Background: Protein markers of cellular proliferation, hypoxia, apoptosis, cell cycle checkpoints, growth factor signalling and inflammation in localised prostate tumours have previously shown prognostic ability. A translational substudy within the CHHiP trial of radiotherapy fractionation evaluated whether these could improve prediction of prognosis and assist treatment stratification following either conventional or hypofractionated radiotherapy.

Methods: Using case:control methodology, patients with biochemical or clinical failure after radiotherapy (BCR) were matched to patients without recurrence according to established prognostic factors (Gleason score, presenting PSA, tumour-stage) and fractionation schedule.

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Background: Post-treatment detection of circulating tumour DNA (ctDNA) in early-stage triple-negative breast cancer (TNBC) patients predicts high risk of relapse. c-TRAK TN assessed the utility of prospective ctDNA surveillance in TNBC and the activity of pembrolizumab in patients with ctDNA detected [ctDNA positive (ctDNA+)].

Patients And Methods: c-TRAK TN, a multicentre phase II trial, with integrated prospective ctDNA surveillance by digital PCR, enrolled patients with early-stage TNBC and residual disease following neoadjuvant chemotherapy, or stage II/III with adjuvant chemotherapy.

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Purpose: We estimated the cost-effectiveness of 4 radiotherapy modalities to treat early breast cancer in the UK. In a subgroup of patients eligible for all modalities, we compared whole-breast (WB) and partial breast (PB) radiotherapy delivered in either 15 (WB15F, PB15F) or 5 fractions (WB5F, PB5F). In a subgroup ineligible for PB radiotherapy, we compared WB15F to WB5F.

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Background: Around 7500 people are diagnosed with non-muscle-invasive bladder cancer in the UK annually. Recurrence following transurethral resection of bladder tumour is common, and the intensive monitoring schedule required after initial treatment has associated costs for patients and the NHS. In photodynamic diagnosis, before transurethral resection of bladder tumour, a photosensitiser that is preferentially absorbed by tumour cells is instilled intravesically.

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Article Synopsis
  • The study explores how the timing of androgen-deprivation therapy (ADT) relative to radiotherapy (RT) affects outcomes for prostate cancer, particularly comparing prostate-only RT (PORT) and whole-pelvis RT (WPRT).
  • Researchers analyzed data from 12 randomized trials involving 7,409 patients and utilized advanced statistical methods to assess the impact of ADT sequencing on metastasis-free survival and overall survival.
  • Findings indicated that for patients receiving PORT, concurrent/adjuvant ADT resulted in better metastasis-free survival and lower rates of prostate cancer-specific mortality, whereas WPRT showed no significant differences in outcomes based on ADT timing.
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Glioblastoma multiforme (GBM) is the most aggressive astrocytic primary brain tumor, and concurrent temozolomide (TMZ) and radiotherapy (RT) followed by maintenance of adjuvant TMZ is the current standard of care. Despite advances in imaging techniques and multi-modal treatment options, the median overall survival (OS) remains poor. As an alternative to surgery, re-irradiation (re-RT) can be a therapeutic option in recurrent GBM.

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Overall survival in the OlympiA phase III trial of adjuvant olaparib in patients with germline pathogenic variants in BRCA1/2 and high-risk, early breast cancer.

Ann Oncol

December 2022

The Breast Cancer Now Toby Robins Research Centre, The Institute of Cancer Research, London; The Breast Cancer Now Unit, Guy's Hospital Cancer Centre, King's College London, London, UK. Electronic address:

Background: The randomized, double-blind OlympiA trial compared 1 year of the oral poly(adenosine diphosphate-ribose) polymerase inhibitor, olaparib, to matching placebo as adjuvant therapy for patients with pathogenic or likely pathogenic variants in germline BRCA1 or BRCA2 (gBRCA1/2pv) and high-risk, human epidermal growth factor receptor 2-negative, early breast cancer (EBC). The first pre-specified interim analysis (IA) previously demonstrated statistically significant improvement in invasive disease-free survival (IDFS) and distant disease-free survival (DDFS). The olaparib group had fewer deaths than the placebo group, but the difference did not reach statistical significance for overall survival (OS).

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Purpose: To identify potential immune targets in post-neoadjuvant chemotherapy (NAC)-resistant triple-negative breast cancer (TNBC) and ER+HER2- breast cancer disease.

Experimental Design: Following pathology review, 153 patients were identified as having residual cancer burden (RCB) II/III disease (TNBC n = 80; ER+HER2-n = 73). Baseline pre-NAC samples were available for evaluation for 32 of 80 TNBC and 36 of 73 ER+HER2- cases.

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Background: Prostate cancer is a very prevalent disease in men. Patients are monitored regularly during and after treatment with repeated assessment of prostate-specific antigen (PSA) levels. Prognosis of localised prostate cancer is generally good after treatment, and the risk of having a recurrence is usually estimated based on factors measured at diagnosis.

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