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1.
Zhonghua Zhong Liu Za Zhi ; 42(8): 617-623, 2020 Aug 23.
Artigo em Chinês | MEDLINE | ID: mdl-32867451

RESUMO

As a new type of anthracyclines, pegylated liposomal doxorubicin (PLD) is widely used in the treatment of a variety of malignant tumors, including soft tissue sarcoma, ovarian cancer, breast cancer, multiple myeloma, and so on. Compared with traditional anthracyclines, PLD can significantly decrease the incidences of adverse events such as cardiac toxicity and alopecia. However, the use of PLD will be accompanied with toxic side effects such as hand-foot syndrome, oral mucositis, and infusion reaction. This consensus will mainly focus on the mechanism, prevention and treatment of adverse events of PLD, in order to improve the therapeutic efficacy of PLD and life quality of patients.


Assuntos
Antibióticos Antineoplásicos/efeitos adversos , Doxorrubicina/análogos & derivados , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/prevenção & controle , Síndrome Mão-Pé/complicações , Neoplasias/tratamento farmacológico , Estomatite/complicações , Antibióticos Antineoplásicos/uso terapêutico , Consenso , Doxorrubicina/efeitos adversos , Doxorrubicina/uso terapêutico , Feminino , Humanos , Polietilenoglicóis/efeitos adversos , Polietilenoglicóis/uso terapêutico , Guias de Prática Clínica como Assunto
2.
Curr Opin Ophthalmol ; 31(5): 403-415, 2020 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-32740062

RESUMO

PURPOSE OF REVIEW: To compile and report the ocular manifestations of coronavirus disease 2019 (COVID-19) infection and summarize the ocular side effects of investigational treatments of this disease. RECENT FINDINGS: Conjunctivitis is by far the most common ocular manifestation of COVID-19 with viral particles being isolated from tears/secretions of infected individuals. Multiple therapeutic options are being explored across a variety of medication classes with diverse ocular side effects. SUMMARY: Eye care professionals must exercise caution, as conjunctivitis may be the presenting or sole finding of an active COVID-19 infection. While no currently studied therapeutic agents have been found to reliably treat COVID-19, early vaccination trials are progressing and show promise. A video abstract is available for a more detailed summary. VIDEO ABSTRACT: http://links.lww.com/COOP/A36.


Assuntos
Betacoronavirus/isolamento & purificação , Conjuntivite Viral/diagnóstico , Infecções por Coronavirus/diagnóstico , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/etiologia , Drogas em Investigação/efeitos adversos , Oftalmopatias/induzido quimicamente , Pneumonia Viral/diagnóstico , Lágrimas/virologia , Conjuntivite Viral/tratamento farmacológico , Conjuntivite Viral/virologia , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/prevenção & controle , Oftalmopatias/prevenção & controle , Humanos , Pandemias
3.
Iran J Kidney Dis ; 14(4): 247-255, 2020 07.
Artigo em Inglês | MEDLINE | ID: mdl-32655019

RESUMO

Treatment of coronavirus disease 2019 (COVID-19) among patients with CKD requires special pharmacotherapy considerations that are reviewed here. Literature review was done for several pharmacotherapy aspects in CKD patients including selection and modification of COVID-19 treatment, drug interactions, nephrotoxicity of drugs that are used for treatment of COVID-19 and potential risks/benefits of routine medications of CKD patients during COVID-19 pandemic. CKD patients should be treated according to local or national COVID-19 protocols as other patients. But, there is no data on using remdesivir in patients with severe CKD. Oseltamivir and ribavirin require dose modification in patients with moderate to severe CKD. Nephrolithiasis, CKD, and acute interstitial nephritis have been reported with protease inhibitors. Acute kidney injury has been reported with remdesivir in patients with severe COVID-19. Pharmacokinetic-enhanced protease inhibitors increase the concentration of some drugs such as statins, cinacalcet, steroids, calcineurin inhibitors (CNIs). Some hypothetical benefits and harms have been suggested for statins and renin-angiotensinaldosterone system inhibitors in COVID-19 patients. Continuing guideline-directed administration of these drugs is recommended. Among different immunomodulating/immunosuppressive drugs, hydroxychloroquine and CNIs are the safest ones during COVID-19. Antimetabolites are suggested to be withheld during moderate to severe COVID-19. Fluid therapy and anticoagulant prophylaxis/ treatment need special attention in CKD patients with COVID-19. CKD patients with COVID-19 are treated as other patients, with some dose modifications if needed. Be mindful for management of drug interactions as well as modification of immunosuppressive drugs in patients with moderate to severe COVID-19.


Assuntos
Infecções por Coronavirus , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos , Pandemias , Pneumonia Viral , Insuficiência Renal Crônica , Betacoronavirus/isolamento & purificação , Comorbidade , Infecções por Coronavirus/classificação , Infecções por Coronavirus/complicações , Infecções por Coronavirus/tratamento farmacológico , Infecções por Coronavirus/epidemiologia , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/classificação , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/etiologia , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/prevenção & controle , Humanos , Seleção de Pacientes , Pneumonia Viral/tratamento farmacológico , Pneumonia Viral/epidemiologia , Insuficiência Renal Crônica/tratamento farmacológico , Insuficiência Renal Crônica/epidemiologia , Medição de Risco
6.
Nervenarzt ; 91(7): 604-610, 2020 Jul.
Artigo em Alemão | MEDLINE | ID: mdl-32488413

RESUMO

In view of the current coronavirus disease 2019 (COVID-19) pandemic, patient care, including that of psychiatric patients, is facing unprecedented challenges. Treatment strategies for mental illness include psychotherapy and psychopharmacological interventions. The latter are associated with a multitude of adverse drug reactions (ADR); however, they may currently represent the preferred treatment due to restrictions regarding patient care (i.e. social distancing). Direct contact to patients may have to be reduced in favor of telephone calls or video conferences, so that new techniques in diagnosing and treating patients have to be established to guarantee patient safety. Patients should be extensively informed about relevant ADRs and physicians should actively ask patients about the timely recognition of ADRs. The use of psychotropic drugs may lead to an increased risk of developing ADRs, which are considered to be particularly unfavorable if they occur simultaneously with an acute infection or may even lead to an increased risk of infection. These include respiratory depression, agranulocytosis, intoxication by inhibition of metabolizing enzymes and venous thromboembolism, each of which may be associated with potentially fatal consequences; however, physicians should simultaneously ensure adequate efficacy of treatment, since the ongoing crisis may lead to a worsening of preexisting mental illnesses and to a surge in first onset of psychiatric disorders.


Assuntos
Infecções por Coronavirus , Pandemias , Pneumonia Viral , Psicoterapia , Psicotrópicos , Betacoronavirus , Infecções por Coronavirus/psicologia , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/prevenção & controle , Humanos , Pandemias/estatística & dados numéricos , Pneumonia Viral/psicologia , Psicoterapia/métodos , Psicoterapia/organização & administração , Psicotrópicos/administração & dosagem , Psicotrópicos/efeitos adversos
8.
Anesthesiology ; 133(2): 332-341, 2020 08.
Artigo em Inglês | MEDLINE | ID: mdl-32541549

RESUMO

BACKGROUND: While 4 to 10% of medications administered in the operating room may involve an error, few investigations have prospectively modeled how these errors might occur. Systems theoretic process analysis is a prospective risk analysis technique that uses systems theory to identify hazards. The purpose of this study was to demonstrate the use of systems theoretic process analysis in a healthcare organization to prospectively identify causal factors for medication errors in the operating room. METHODS: The authors completed a systems theoretic process analysis for the medication use process in the operating room at their institution. First, the authors defined medication-related accidents (adverse medication events) and hazards and created a hierarchical control structure (a schematic representation of the operating room medication use system). Then the authors analyzed this structure for unsafe control actions and causal scenarios that could lead to medication errors, incorporating input from surgeons, anesthesiologists, and pharmacists. The authors studied the entire medication use process, including requesting medications, dispensing, preparing, administering, documenting, and monitoring patients for the effects. Results were reported using descriptive statistics. RESULTS: The hierarchical control structure involved three tiers of controllers: perioperative leadership; management of patient care by the attending anesthesiologist, surgeon, and pharmacist; and execution of patient care by the anesthesia clinician in the operating room. The authors identified 66 unsafe control actions linked to 342 causal scenarios that could lead to medication errors. Eighty-two (24.0%) scenarios came from perioperative leadership, 103 (30.1%) from management of patient care, and 157 (45.9%) from execution of patient care. CONCLUSIONS: In this study, the authors demonstrated the use of systems theoretic process analysis to describe potential causes of errors in the medication use process in the operating room. Causal scenarios were linked to controllers ranging from the frontline providers up to the highest levels of perioperative management. Systems theoretic process analysis is uniquely able to analyze management and leadership impacts on the system, making it useful for guiding quality improvement initiatives.


Assuntos
Anestesiologia/normas , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/prevenção & controle , Erros de Medicação/prevenção & controle , Salas Cirúrgicas/normas , Melhoria de Qualidade/normas , Teoria de Sistemas , Anestesiologistas/normas , Humanos , Salas Cirúrgicas/métodos , Farmacêuticos/normas , Estudos Prospectivos , Cirurgiões/normas
10.
Pharm Res ; 37(5): 86, 2020 Apr 30.
Artigo em Inglês | MEDLINE | ID: mdl-32356247

RESUMO

PURPOSE: Adverse events (AEs) caused by polypharmacy have recently become a clinical problem, and it is important to monitor the safety profile of drug-drug interactions (DDIs). Mining signals using the spontaneous reporting systems is a very effective method for single drug-induced AE monitoring as well as early detection of DDIs. The objective of this study was to compare signal detection algorithms for DDIs based on frequency statistical models. METHODS: Five frequency statistical models: the Ω shrinkage measure, additive (risk difference), multiplicative (risk ratio), combination risk ratio, and chi-square statistics models were compared using the Japanese Adverse Drug Event Report (JADER) database as the spontaneous reporting system in Japan. The drugs targeted for the survey are all registered and classified as "suspect drugs" in JADER, and the AEs targeted for this study were the same as those in a previous study on Stevens-Johnson syndrome (SJS). RESULTS: Of 3924 pairs that reported SJS, the number of signals detected by the Ω shrinkage measure, additive, multiplicative, combination risk ratio, and chi-square statistics models was 712, 3298, 2252, 739, and 1289 pairs, respectively. Among the five models, the Ω shrinkage measure model showed the most conservative signal detection tendency. CONCLUSION: Specifically, caution should be exercised when the number of reports is low because results differ depending on the statistical models. This study will contribute to the selection of appropriate statistical models to detect signals of potential DDIs.


Assuntos
Sistemas de Notificação de Reações Adversas a Medicamentos , Algoritmos , Interações Medicamentosas , Modelos Estatísticos , Bases de Dados Factuais , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/prevenção & controle , Humanos , Modelos Químicos , Razão de Chances
11.
Croat Med J ; 61(2): 147-158, 2020 Apr 30.
Artigo em Inglês | MEDLINE | ID: mdl-32378381

RESUMO

Older people are increasingly susceptible to adverse drug reactions (ADRs) or therapeutic failure. This could be mediated by considerable polypharmacy, which increases the possibility of drug-drug and drug-gene interactions. Precision medicine, based on individual genetic variations, enables the screening of patients at risk for ADRs and the implementation of personalized treatment regimens. It combines genetic and genomic data with environmental and clinical factors in order to tailor prevention and disease-management strategies, including pharmacotherapy. The identification of genetic factors that influence drug absorption, distribution, metabolism, excretion, and action at the drug target level allows individualized therapy. Positive pharmacogenomic findings have been reported for the majority of cardiovascular drugs (CVD), suggesting that pre-emptive testing can improve efficacy and minimize the toxicity risk. Gene variants related to drug metabolism and transport variability or pharmacodynamics of major CVD have been translated into dosing recommendations. Pharmacogenetics consortia have issued guidelines for oral anticoagulants, antiplatelet agents, statins, and some beta-blockers. Since the majority of pharmacogenetics recommendations are based on the assessment of single drug-gene interactions, it is imperative to develop tools for the prediction of multiple drug-drug-gene interactions, which are common in the elderly with comorbidity. The availability of genomic testing has grown, but its clinical application is still insufficient.


Assuntos
Doenças Cardiovasculares , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/prevenção & controle , Farmacogenética , Idoso , Fármacos Cardiovasculares/efeitos adversos , Fármacos Cardiovasculares/uso terapêutico , Doenças Cardiovasculares/tratamento farmacológico , Doenças Cardiovasculares/genética , Humanos , Medicina de Precisão
13.
BMC Health Serv Res ; 20(1): 220, 2020 Mar 17.
Artigo em Inglês | MEDLINE | ID: mdl-32183810

RESUMO

BACKGROUND: Several approaches to medication optimisation by identifying drug-related problems in older people have been described. Although some interventions have shown reductions in drug-related problems (DRPs), evidence supporting the effectiveness of medication reviews on clinical and economic outcomes is lacking. Application of the STOPP/START (version 2) explicit screening tool for inappropriate prescribing has decreased inappropriate prescribing and significantly reduced adverse drug reactions (ADRs) and associated healthcare costs in older patients with multi-morbidity and polypharmacy. Therefore, application of STOPP/START criteria during a medication review is likely to be beneficial. Incorporation of explicit screening tools into clinical decision support systems (CDSS) has gained traction as a means to improve both quality and efficiency in the rather time-consuming medication review process. Although CDSS can generate more potential inappropriate medication recommendations, some of these have been shown to be less clinically relevant, resulting in alert fatigue. Moreover, explicit tools such as STOPP/START do not cover all relevant DRPs on an individual patient level. The OPERAM study aims to assess the impact of a structured drug review on the quality of pharmacotherapy in older people with multi-morbidity and polypharmacy. The aim of this paper is to describe the structured, multi-component intervention of the OPERAM trial and compare it with the approach in the comparator arm. METHOD: This paper describes a multi-component intervention, integrating interventions that have demonstrated effectiveness in defining DRPs. The intervention involves a structured history-taking of medication (SHiM), a medication review according to the systemic tool to reduce inappropriate prescribing (STRIP) method, assisted by a clinical decision support system (STRIP Assistant, STRIPA) with integrated STOPP/START criteria (version 2), followed by shared decision-making with both patient and attending physician. The developed method integrates patient input, patient data, involvement from other healthcare professionals and CDSS-assistance into one structured intervention. DISCUSSION: The clinical and economical effectiveness of this experimental intervention will be evaluated in a cohort of hospitalised, older patients with multi-morbidity and polypharmacy in the multicentre, randomized controlled OPERAM trial (OPtimising thERapy to prevent Avoidable hospital admissions in the Multi-morbid elderly), which will be completed in the last quarter of 2019. TRIAL REGISTRATION: Universal Trial Number: U1111-1181-9400 Clinicaltrials.gov: NCT02986425, Registered 08 December 2016. FOPH (Swiss national portal): SNCTP000002183. Netherlands Trial Register: NTR6012 (07-10-2016).


Assuntos
Sistemas de Apoio a Decisões Clínicas , Hospitalização , Prescrição Inadequada/prevenção & controle , Reconciliação de Medicamentos/métodos , Lista de Medicamentos Potencialmente Inapropriados , Idoso , Doença Crônica/tratamento farmacológico , Estudos de Coortes , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/prevenção & controle , Humanos , Multimorbidade , Polimedicação , Projetos de Pesquisa
14.
PLoS One ; 15(3): e0230167, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32214334

RESUMO

Cannabis related online searches are associated with positive attitudes toward medical cannabis, particularly when information is obtained from dispensaries. Since pain is the main reason for medicinal cannabis use, information from dispensary websites has the potential to shape the attitude of pain patients towards cannabis. This is relevant because cannabis has demonstrated efficacy in neuropathic pain with low tetrahydrocannabinol (THC) concentrations (< 5-10%), in contrast to potent cannabis (>15% THC), which is highly rewarded in the recreational realm. The role of CBD in pain is not clear, however it has gained popularity. Thus, we hypothesize that the potency of medical cannabis that is advertised online is similar to the cannabis advertised for recreational purposes, which would potentially create a misconception towards medical cannabis. The current lack of knowledge surrounding advertised potencies in the legal cannabis market limits the ability to generate clear policies regarding online advertising to protect patients that are willing to use cannabis for their condition. Thus, we evaluated the advertised THC and CBD content of cannabis products offered online in dispensaries in the United States to determine products' suitability to medicinal use and compare the strength of products offered in legal medical and recreational programs. We recorded THC and CBD concentrations for all herb cannabis products provided by dispensary websites and compared them between or within states. Four Western states (CA, CO, NM, WA) and five Northeastern states (ME, MA, NH, RI, VT) were included. A total of 8,505 cannabis products across 653 dispensaries were sampled. Despite the clear differences between medicinal and recreational uses of cannabis, the average THC concentration advertised online in medicinal programs was similar (19.2% ±6.2) to recreational programs (21.5% ±6.0) when compared between states with different programs, or between medicinal and recreational programs within the same states (CO or WA). Lower CBD concentrations accompanied higher THC products. The majority of products, regardless of medicinal or recreational programs, were advertised to have >15% THC (70.3% - 91.4% of products). These stated concentrations seem unsuitable for medicinal purposes, particularly for patients with chronic neuropathic pain. Therefore, this information could induce the misconception that high potency cannabis is safe to treat pain. This data is consistent with reports in which THC and CBD in products from legal dispensaries or in nationwide products from the illegal market were actually measured, which indicates that patients consuming these products may be at risk of acute intoxication or long-term side effects. Our study offers grounds to develop policies that help prevent misconceptions toward cannabis and reduce risks in pain patients.


Assuntos
Drogas Ilícitas/farmacologia , Maconha Medicinal/farmacologia , Analgésicos/farmacologia , Cannabis , Dronabinol/farmacologia , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/prevenção & controle , Humanos , Neuralgia/tratamento farmacológico , Estados Unidos
15.
Support Care Cancer ; 28(8): 3557-3569, 2020 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-32189099

RESUMO

PURPOSE: Medication reconciliation can reduce drug-related iatrogenesis by facilitating exhaustive information transmission at care transition points. Given the vulnerability of cancer patients to adverse drug events, medication reconciliation could provide a significant clinical benefit in cancer care. This review aims to synthesize existing evidence on medication reconciliation in cancer patients. METHODS: A comprehensive search was performed in the PubMed/Medline, Scopus, and Web of Science databases, associating the keywords "medication reconciliation" and "cancer" or "oncology." RESULTS: Fourteen studies met the selection criteria. Various medication reconciliation practices were reported: performed at admission or discharge, for hospitalized or ambulatory patients treated with oral or parenteral anticancer drugs. In one randomized controlled trial, medication reconciliation decreased clinically significant medication errors by 26%. Although most studies were non-comparative, they highlighted that medication reconciliation led to identification of discrepancies and other drug-related problems in up to 88% and 94.7% of patients, respectively. The impact on post-discharge healthcare utilization remains under-evaluated and mostly inconclusive, despite a trend toward reduction. No comparative economic evaluations were available but one study estimated the benefit:cost ratio of medication reconciliation to be 2.31:1, suggesting its benefits largely outweigh its costs. Several studies also underlined the extended pharmacist time required for the intervention, highlighting the need for further cost analysis. CONCLUSION: Medication reconciliation can reduce adverse drug events in cancer patients. More robust and economic evaluations are still required to support its development in everyday practice.


Assuntos
Reconciliação de Medicamentos/métodos , Neoplasias/tratamento farmacológico , Neoplasias/economia , Antineoplásicos/administração & dosagem , Antineoplásicos/efeitos adversos , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/prevenção & controle , Humanos , Reconciliação de Medicamentos/economia , Ensaios Clínicos Controlados Aleatórios como Assunto
16.
Expert Opin Pharmacother ; 21(7): 741-746, 2020 May.
Artigo em Inglês | MEDLINE | ID: mdl-32037906

RESUMO

INTRODUCTION: Oral minocycline is a mainstay of therapy for moderate-to-severe acne; however, systemic side effects which include hepatotoxicity, lupus-like syndrome, drug hypersensitivity syndrome, autoimmune hepatitis, polyarteritis nodosa, gastrointestinal side effects and skin hyperpigmentation are of concern. Topical antibiotics commonly used in acne, such as erythromycin and clindamycin, present high P. acnes resistance rates which has opened the market for new topical antibiotics. FMX-101 is a novel topical minocycline foam that has shown promising results in phase I, II and III trials for the treatment of moderate-to-severe acne with a better safety profile than oral minocycline. AREAS COVERED: The author provides an overview FMX-101 including its clinical efficacy and safety. The author then provides their expert opinion on this treatment and its potential for the treatment option for acne. EXPERT OPINION: The topical foam formulation of FMX-101 has been shown to reduce both inflammatory and non-inflammatory lesions and to improve IGA scores in patients with moderate-to-severe acne without significant systemic absorption thus limiting associated side effects. Overall, the proven efficacy and safety profile of FMX-101, together with the low systemic absorption, high skin tolerability and cosmetically acceptable foam formulations render this novel therapy an important addition to the acne treatment armamentarium.


Assuntos
Acne Vulgar/tratamento farmacológico , Antibacterianos/uso terapêutico , Minociclina/uso terapêutico , Administração Cutânea , Antibacterianos/administração & dosagem , Antibacterianos/efeitos adversos , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/etiologia , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/prevenção & controle , Humanos , Minociclina/administração & dosagem , Minociclina/efeitos adversos , Ensaios Clínicos Controlados Aleatórios como Assunto , Pele/efeitos dos fármacos , Pele/patologia , Resultado do Tratamento
17.
Pharmaceut Med ; 34(1): 1-5, 2020 02.
Artigo em Inglês | MEDLINE | ID: mdl-32048215

RESUMO

The process for amending a European Union Risk Management Plan (EU-RMP) with new information requires the submission of a formal variation procedure, of which there are four distinct categories: Type IA, Type IB, Type II, and 'Extension of a marketing authorisation' (or simply 'extension'). A Type II variation, in accordance with the above-referenced European Commission regulation, is defined as 'a variation that is not an extension of the marketing authorisation (line extension) and that may have a significant impact on the quality, safety or efficacy of a medicinal product'. Additional detail regarding which type of variation should be submitted in specific circumstances is provided in the accompanying guideline. Common working practice for submission strategies when managing multiple Type II variations has been to either submit each in sequence or submit several parallel procedures each with its own corresponding EU-RMP. Submitting in sequence results in a prolonged, end-to-end process with each procedure resulting in a new, iterative version of the EU-RMP. Alternatively, submitting multiple parallel variations with their own corresponding EU-RMPs can result in very complicated procedural wrap-up activities and very short-lived approved versions. In this article, we describe an approach to the management of multiple Type II variations, which is now in line with the recently revised European Medicines Agency (EMA) frequently asked questions (FAQ) guidance on how to manage grouped Type II variation applications, whereby four parallel Type II variation procedures were successfully initiated simultaneously with a single EU-RMP.


Assuntos
Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/diagnóstico , União Europeia/organização & administração , Aprovação de Drogas , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/prevenção & controle , Guias como Assunto , Humanos , Legislação de Medicamentos , Marketing de Serviços de Saúde , Farmacovigilância , Gestão de Riscos
19.
BMC Cancer ; 20(1): 16, 2020 Jan 06.
Artigo em Inglês | MEDLINE | ID: mdl-31906955

RESUMO

BACKGROUND: Improved, multimodal treatment strategies have been shown to increase cure rates in cancer patients. Those who survive cancer as a child, adolescent or young adult (CAYA), are at a higher risk for therapy-, or disease-related, late or long-term effects. The CARE for CAYA-Program has been developed to comprehensively assess any potential future problems, to offer need-based preventative interventions and thus to improve long-term outcomes in this particularly vulnerable population. METHODS: The trial is designed as an adaptive trial with an annual comprehensive assessment followed by needs stratified, modular interventions, currently including physical activity, nutrition and psycho-oncology, all aimed at improving the lifestyle and/or the psychosocial situation of the patients. Patients, aged 15-39 years old, with a prior cancer diagnosis, who have completed tumour therapy and are in follow-up care, and who are tumour free, will be included. At baseline (and subsequently on an annual basis) the current medical and psychosocial situation and lifestyle of the participants will be assessed using a survey compiled of various validated questionnaires (e.g. EORTC QLQ C30, NCCN distress thermometer, PHQ-4, BSA, nutrition protocol) and objective parameters (e.g. BMI, WHR, co-morbidities like hyperlipidaemia, hypertension, diabetes), followed by basic care (psychological and lifestyle consultation). Depending on their needs, CAYAs will be allocated to preventative interventions in the above-mentioned modules over a 12-month period. After 1 year, the assessment will be repeated, and further interventions may be applied as needed. During the initial trial phase, the efficacy of this approach will be compared to standard care (waiting list with intervention in the following year) in a randomized study. During this phase, 530 CAYAs will be included and 320 eligible CAYAs who are willing to participate in the interventions will be randomly allocated to an intervention. Overall, 1500 CAYAs will be included and assessed. The programme is financed by the innovation fund of the German Federal Joint Committee and will be conducted at 14 German sites. Recruitment began in January 2018. DISCUSSION: CAYAs are at high risk for long-term sequelae. Providing structured interventions to improve lifestyle and psychological situation may counteract against these risk factors. The programme serves to establish uniform regular comprehensive assessments and need-based interventions to improve long-term outcome in CAYA survivors. TRIAL REGISTRATION: Registered at the German Clinical Trial Register (ID: DRKS00012504, registration date: 19th January 2018).


Assuntos
Assistência ao Convalescente/métodos , Sobreviventes de Câncer/psicologia , Adolescente , Adulto , Assistência ao Convalescente/organização & administração , Criança , Depressão/psicologia , Depressão/terapia , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/complicações , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/prevenção & controle , Exercício Físico/fisiologia , Feminino , Humanos , Estilo de Vida , Masculino , Neoplasias/complicações , Neoplasias/psicologia , Avaliação Nutricional , Medicina Preventiva/métodos , Medicina Preventiva/organização & administração , Fatores de Risco , Inquéritos e Questionários , Fatores de Tempo , Adulto Jovem
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