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1.
Eur J Cancer Care (Engl) ; 31(6): e13761, 2022 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-36330596

RESUMO

OBJECTIVE: Childhood cancer survivors experience reduced physical activity level, participation as well as health-related quality of life. This prospective, pre-/post-intervention and follow-up cohort study aims to determine the efficacy of an interdisciplinary rehabilitation on improving physical fitness, fatigue and body composition. METHODS: A total of 24 childhood cancer survivors (mean age: 12.15 years ± 3.2; 14 females; 10 males) were recruited 6 months after medical treatment and received a 4-month interdisciplinary intervention. Cardiorespiratory fitness (PredVO2peak and PredLoadmax ), body composition (dry lean weight) and quality of life (general fatigue) were assessed at baseline, post-intervention and 1-year follow-up. Linear mixed models were used to analyse data. RESULTS: Linear mixed modelling revealed a significant main effect of time on predicted maximal load (F = 13.189, df = 36.179, p < 0.001), dry lean weight (F = 64.813, df = 37.019, p < 0.001) but also significant improvement of general fatigue score (-9.039 ± 4.300, 95% CI -17.741 to -0.336, p = 0.042), indicating a decline in general fatigue. CONCLUSION: With emerging evidence that physical activity is safe and feasible, together with increasing numbers of childhood cancer survivors at risk for long-term chronic co-morbidities, this study advocates for better access to interdisciplinary rehabilitation programmes in order to improve their physical condition and their body composition and reduce fatigue.


Assuntos
Sobreviventes de Câncer , Neoplasias , Criança , Masculino , Feminino , Humanos , Seguimentos , Qualidade de Vida , Estudos Prospectivos , Neoplasias/terapia , Aptidão Física , Fadiga , Composição Corporal
2.
Trials ; 23(1): 864, 2022 Oct 08.
Artigo em Inglês | MEDLINE | ID: mdl-36209235

RESUMO

BACKGROUND: Rifampicin-resistant tuberculosis (RR-TB) remains an important global health problem. Ideally, the complete drug-resistance profile guides individualized treatment for all RR-TB patients, but this is only practised in high-income countries. Implementation of whole genome sequencing (WGS) technologies into routine care in low and middle-income countries has not become a reality due to the expected implementation challenges, including translating WGS results into individualized treatment regimen composition. METHODS: This trial is a pragmatic, single-blinded, randomized controlled medical device trial of a WGS-guided automated treatment recommendation strategy for individualized treatment of RR-TB. Subjects are 18 years or older and diagnosed with pulmonary RR-TB in four of the five health districts of the Free State province in South Africa. Participants are randomized in a 1:1 ratio to either the intervention (a WGS-guided automated treatment recommendation strategy for individualized treatment of RR-TB) or control (RR-TB treatment according to the national South African guidelines). The primary effectiveness outcome is the bacteriological response to treatment measured as the rate of change in time to liquid culture positivity during the first 6 months of treatment. Secondary effectiveness outcomes include cure rate, relapse rate (recurrence of RR-TB disease) and TB free survival rate in the first 12 months following RR-TB treatment completion. Additional secondary outcomes of interest include safety, the feasibility of province-wide implementation of the strategy into routine care, and health economic assessment from a patient and health systems perspective. DISCUSSION: This trial will provide important real-life evidence regarding the feasibility, safety, cost, and effectiveness of a WGS-guided automated treatment recommendation strategy for individualized treatment of RR-TB. Given the pragmatic nature, the trial will assist policymakers in the decision-making regarding the integration of next-generation sequencing technologies into routine RR-TB care in high TB burden settings. TRIAL REGISTRATION: ClinicalTrials.gov NCT05017324. Registered on August 23, 2021.


Assuntos
Mycobacterium , Tuberculose Resistente a Múltiplos Medicamentos , Algoritmos , Antituberculosos/efeitos adversos , Ensaios Clínicos Fase IV como Assunto , Humanos , Recidiva Local de Neoplasia , Ensaios Clínicos Pragmáticos como Assunto , Ensaios Clínicos Controlados Aleatórios como Assunto , Rifampina/efeitos adversos , Tuberculose Resistente a Múltiplos Medicamentos/diagnóstico , Tuberculose Resistente a Múltiplos Medicamentos/tratamento farmacológico
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