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BACKGROUND: Chemoradiotherapy with high-dose cisplatin (HD-Cis: 100 mg/m2 q3w for three cycles) is the standard of care (SOC) in locally advanced head and neck squamous cell carcinoma (LA-HNSCC). Cumulative delivered dose of cisplatin is prognostic of survival, even beyond 200 mg/m2 but high toxicity compromises its delivery. AIM: Cisplatin fractionation may allow, by decreasing the peak serum concentration, to decrease toxicity. To date, no direct comparison was done of HD-Cis versus fractionated high dose cisplatin (FHD-Cis). METHODS: This is a multi-institutional randomized phase II trial, stratified on postoperative or definitive chemoradiotherapy, comparing HD-Cis to FHD-Cis (25 mg/m2/d d1-4 q3w for 3 cycles) in patients with LA-HNSCC. The primary endpoint was the cumulative delivered cisplatin dose. RESULTS: Between December 2015 and April 2018, 124 patients were randomized. Median cisplatin cumulative delivered dose was 291 mg/m2 (IQR: 251;298) in the FHD-Cis arm and 274 mg/m2 (IQR: 198;295) in the HD-Cis arm (P = 0.054). The proportion of patients receiving a third cycle of cisplatin was higher, with a lower proportion of grade 3-4 acute AEs in the FHD-Cis arm compared to the HD-Cis arm: 81 % vs. 64 % (P = 0.04) and 10 % vs. 17 % (P = 0.002), respectively. With a median follow-up of 48 months (IQR: 41;55), locoregional failure rate, PFS and OS were similar between the two arms. CONCLUSION: Although the primary endpoint was not met, FHD-Cis allowed more cycles of cisplatin to be delivered with lower toxicity, when compared to SOC. FHD-Cis concurrently with RT is a treatment option which deserves further consideration.
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Este artículo tiene como objetivo comprender las creencias sociales y orientaciones emocionales colectivas sobre la protesta social en el proceso de construcción de paz en Colombia. Se utilizó una metodología cualitativa con enfoque hermenéutico y se realizó un análisis de contenido sobre lo expresado en entrevistas semiestructuradas por 18 participantes, ciudadanos del común, quienes se asumieron "a favor de la protesta social", "en contra de la protesta social" y "ambivalentes". Como resultados, se contrastaron creencias y orientaciones emocionales colectivas favorables, como empatía y comprensión, con prejuicios y estigmas. Emergieron creencias sobre el "otro" opositor, como enemigo, expresiones de distancia social, discriminación, exclusión y odio. Los medios de comunicación como mecanismos de configuración de estas creencias y orientaciones emocionales colectivas, asociadas al rechazo a los movimientos sociales, por parte de algunos participantes, alimentaron un ambiente de polarización y redujeron las posibilidades del reconocimiento del otro como ser humano.
This research tries to comprehend the societal beliefs and the collective emotions about the social protest in the context of peacebuilding. It was used a qualitative methodology with hermeneutical approach, and it was made an analysis of content about what was said in the semi-structured interviews of 18 participants that were classified in three groups according to their position about the social protest: a group in favor, a group against it, and a third one with an ambivalent position. As a result, there were contrasted the positive societal beliefs and the collective as empathy, understanding against prejudices and stigmata. There were emerged beliefs about the "other" as an opponent and enemy, expressions of social distance between groups, discrimination, exclusion, and hate. The mass media were identified as configuration mechanisms of these societal beliefs and collective emotions, associated to rejection of social movements that feeds the political polarization and reduces the possibility to recognize the other as a human being.
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BACKGROUND: In a previous phase II study an immunonutrient supplement was found to reduce severe acute toxicities for head and neck squamous cell cancer (HNSCC) patients treated with concomitant cisplatin and radiotherapy. OBJECTIVES: The primary objective of the present study was to evaluate efficacy of the same immunonutrient supplement on severe mucositis. Secondary objectives included tolerance, compliance to oral supplementation, chemotherapy interruptions and delays, quality of life, and progression-free survival (PFS) and overall survival (OS) at 1, 2, and 3 y. METHODS: Between November 2009 and June 2013, 180 HNSCC patients eligible for adjuvant chemotherapy after surgery with curative intent were included in our double-blind phase III multicenter trial. They were assigned to receive oral supplementation (3 sachets/d) of either a formula enriched with l-arginine and omega-3 (n-3) fatty and ribonucleic acids (experimental arm), or an isocaloric isonitrogenous control (control arm), for 5 d before each of 3 cycles of cisplatin. Intention-to-treat (ITT) and per-protocol (PP) analyses were undertaken, along with subgroup analyses of ≥75% compliant patients, to compare the incidence of acute mucositis (Radiation Therapy Oncology Group and WHO scales) and 36-mo survival. RESULTS: At 1 mo after terminating chemoradiotherapy (CRT), no differences were observed in the incidence of grade 3-4 mucositis between treatment groups, in the ITT, PP (172 patients), and subgroup (≥75% compliance, n = 112) analyses. The immunomodulating supplement did not significantly improve survival in the ITT and PP analyses at 3 y after CRT. Among ≥75% compliant patients, however, OS at 3 y was significantly improved in the immunomodulating formula group (81%; 95% CI: 67%, 89%) compared with controls (61%; 95% CI: 46%, 73%; P = 0.034), as well as PFS (73%; 95% CI: 58%, 83% compared with 50%; 95% CI: 36%, 63%; P = 0.012). CONCLUSIONS: Although this immunomodulating formula failed to reduce severe mucositis during CRT, the findings suggest that the long-term survival of compliant HNSCC patients was improved.This trial was registered at clinicaltrials.gov as NCT01149642.
Subject(s)
Chemoradiotherapy, Adjuvant , Food, Formulated , Head and Neck Neoplasms/therapy , Immunologic Factors/therapeutic use , Adult , Aged , Dietary Supplements , Double-Blind Method , Female , Humans , Male , Middle Aged , Young AdultABSTRACT
INTRODUCTION: Intensive care units are known as high-stress environments for family members, this can be higher when the patient is a son or daughter and the parents must face the disease along with everything that the hospital environment implies. The Parental Stressor Scale Infant Hospitalization (PSSIH) instrument is a tool used to measure stressors in Pediatric Intensive Care Units (PICU), however, the scale is not validated in Chile. The objective of this study is to culturally validate and adapt the instrument "the modified Parental Stressor Scale Infant Hospitalization" in mothers/fathers of hospitalized children in the PICU of a University Hospital. METHOD: Instrumental validation study. After translating and counter-translating the English version of the instrument, a group of 10 expert professionals evaluated the Spanish adaptation. Then, 10 parents of hospitalized children in the PICU evaluated the understanding of the instrument. The psychometric properties of the instrument were evaluated using exploratory factorial analysis and Cronbach's alpha. RESULTS: The Chilean version of the "modified PSSIH" was applied to a sample of 221 parents, with minimal semantic modifications and the expert judges considered the instrument adequate, therefore, it was not necessary to delete any item. The 3-dimensional solution was chosen, which explained 48.89% of the total instrument variance. The Cronbach's alpha was 0.885, 0.902, and 0.703 respectively for each dimension. Con clusion: The modified PSSIH has proved to be a reliable and valid instrument in a sample of Chilean children hospitalized in a Pediatric Intensive Care Unit of a university hospital. The name in Spanish of the scale is "Escala de Evaluación de Estresores Parentales en niños hospitalizados en Unidades de Cuidados Intensivos Pediátricos" (EEEP - UCIP).
Subject(s)
Child, Hospitalized , Intensive Care Units, Pediatric , Parents/psychology , Stress, Psychological/epidemiology , Adolescent , Adult , Child , Child, Preschool , Chile , Female , Hospitalization , Humans , Infant , Infant, Newborn , Language , Male , Middle Aged , Psychometrics , Surveys and Questionnaires , Young AdultABSTRACT
INTRODUCCIÓN: Las unidades de cuidados intensivos son conocidas como ambientes de alto estrés para los familiares, este puede ser mayor cuando el paciente es un hijo/hija y los padres deben enfrentar la enfermedad y el ambiente hospitalario. El instrumento "The Parental Stressor Scale Infant Hospitali zation (PSSIH), es una herramienta utilizada para medir estresores en Unidades de Cuidados Intensivos Pediátricos (UCIP), sin embargo, la escala no está validada en Chile. El objetivo de este estudio es validar y adaptar culturalmente el instrumento "The Parental Stressor Scale Infant Hospitalization modificado" en madres/padres de niños hospitalizados en la UCIP de un Hospital Universitario. MÉTODO: Estudio instrumental de validación. Luego de traducir y contratraducir la versión en inglés del instrumento, un grupo de 10 profesionales expertos evaluó la adaptación al español. Luego 10 padres/ madres de niños hospitalizados en la UCIP evaluaron la comprensión del instrumento. Las propiedades psicométricas del instrumento fueron evaluadas utilizando un análisis factorial exploratorio y alfa de Cronbach. RESULTADOS: Se aplicó en una muestra de 221 padres/madres la versión chilena del "PSSIH modificado", tuvo mínimas modificaciones semánticas y los jueces expertos consideraron adecuado el instrumento, por lo que no fue necesario borrar ningún ítem. Se eligió la solución de 3 dimensiones, que explicaron el 48,89% de la varianza total del instrumento. El alfa de Cronbach fue de 0,885, 0,902 y 0,703 respectivamente para cada dimensión. CONCLUSIÓN: El PSSIH modificado ha demostrado ser un instrumento confiable y valido en una muestra de niños chilenos hospitalizados en una Unidad de Cuidados Intensivos Pediátricos de un hospital universitario , cuyo nombre en español es "Escala de Evaluación de Estresores Parentales en niños hospitalizados en Unidades de Cuidados Intensivos Pediátricos" (EEEP - UCIP).
INTRODUCTION: Intensive care units are known as high-stress environments for family members, this can be higher when the patient is a son or daughter and the parents must face the disease along with everything that the hospital environment implies. The Parental Stressor Scale Infant Hospitalization (PSSIH) instrument is a tool used to measure stressors in Pediatric Intensive Care Units (PICU), however, the scale is not validated in Chile. The objective of this study is to culturally validate and adapt the instrument "the modified Parental Stressor Scale Infant Hospitalization" in mothers/fathers of hospitalized children in the PICU of a University Hospital. METHOD: Instrumental validation study. After translating and counter-translating the English version of the instrument, a group of 10 expert professionals evaluated the Spanish adaptation. Then, 10 parents of hospitalized children in the PICU evaluated the understanding of the instrument. The psychometric properties of the instrument were evaluated using exploratory factorial analysis and Cronbach's alpha. RESULTS: The Chilean version of the "modified PSSIH" was applied to a sample of 221 parents, with minimal semantic modifications and the expert judges considered the instrument adequate, therefore, it was not necessary to delete any item. The 3-dimensional solution was chosen, which explained 48.89% of the total instrument variance. The Cronbach's alpha was 0.885, 0.902, and 0.703 respectively for each dimension. CONCLUSION: The modified PSSIH has proved to be a reliable and valid instrument in a sample of Chilean children hospitalized in a Pediatric Intensive Care Unit of a university hospital. The name in Spanish of the scale is "Escala de Evaluación de Estresores Parentales en niños hospitalizados en Unidades de Cuidados Intensivos Pediátricos" (EEEP - UCIP).
Subject(s)
Humans , Male , Female , Infant, Newborn , Infant , Child, Preschool , Child , Adolescent , Adult , Middle Aged , Young Adult , Parents/psychology , Stress, Psychological , Intensive Care Units, Pediatric , Child, Hospitalized , Psychometrics , Chile , Surveys and Questionnaires , Hospitalization , LanguageABSTRACT
INTRODUCTION: The hospitalization of a child is a situation that produces a high level of stress on parents, especially at the Pediatric Intensive Care Unit (PICU). OBJECTIVE: To determine which are the main stressors perceived by the parents of children hospitalized at PICU and the associated variables. PATIENTS AND METHOD: A quantitative, cross-sectional and correlational study, which considers the secondary analysis of data from the IDA project # 201403 of UC School of Nursing: Validation of "The parental stressor scale infant hospitalization in Spanish" (PSSIH modified). Sampling was non probabilistic by convenience, with 217 parents of children at the PICU of a University hospital, who answered a demographic questionnaire and the modified PSSIH instrument to measure stressors in the PICU environment. RESULTS: Three dimensions of stressors were identified: Clinical, Emotional and Communication with the professional team. The clinical dimension was the most stressful, with the factors images or sounds, procedures and interventions and the aspect of the child, dimensions related to behavior and communication with the team were less stressful. In addition, it is associated with a greater perception of stress in the different dimensions, when having: previous experiences in PICU, programmed admission, admission due tocardiac pathology, single child, higher educational level and no partner. CONCLUSIONS: The modified PSSIH instrument made it possible to determine the main stressors perceived by the parents of children in the PICU, the Clinical dimension being the major stressor. These results are useful for developing local intervention programs according to the particular characteristics of the PICU.
Subject(s)
Intensive Care Units, Pediatric , Parents/psychology , Stress, Psychological/etiology , Adolescent , Adult , Child , Child, Preschool , Cross-Sectional Studies , Female , Humans , Infant , Infant, Newborn , Male , Middle Aged , Stress, Psychological/diagnosis , Stress, Psychological/psychology , Young AdultABSTRACT
INTRODUCCIÓN: La hospitalización de un hijo es una situación que produce un alto nivel de estrés en padres/madres, especialmente en Unidades de Cuidados Intensivos Pediátricos (UCIP). OBJETIVO: Determinar cuáles son los principales estresores percibidos por los padres/madres de niños/as en UCIP y qué variables se asocian. PACIENTES Y MÉTODO: Estudio cuantitativo, trasversal y correlacional, contempla el análisis secundario de datos del proyecto de Investigación Docente Asistencial # 201403 de Escuela de Enfermería UC: Validación de "The Parental Stressor Scale Infant Hospitalization al español" (PSSIH modificado). El muestreo fue no probabilístico por conveniencia, con 217 padres de niños/as en la UCIP de un hospital universitario, quienes contestaron un cuestionario demográfico y el instrumento PSSIH modificado para medir estresores en el ambiente de la UCIP. RESULTADOS: Se identificaron 3 dimensiones de estresores: Clínica, Emocional y Comunicación con el equipo profesional. La dimensión clínica fue la más estresante, con los factores imágenes o sonidos, procedimientos e intervenciones y el aspecto del hijo, las dimensiones relacionadas con la conducta y la comunicación con el equipo resultaron menos estresantes. Además, se asocian a una mayor percepción de estrés para las distintas dimensiones, tener: experiencias previas en UCIP, ingreso programado, ingreso por patología cardiaca, hijo único, mayor nivel educacional y no tener pareja. CONCLUSIONES: El instrumento PSSIH modificado permitió determinar principales estresores percibidos por los padres/ madres de niños/as en UCIP, siendo la dimensión Clínica, el mayor estresor. Estos resultados son útiles para desarrollar programas de intervención local según características particulares de las UCIP.
INTRODUCTION: The hospitalization of a child is a situation that produces a high level of stress on parents, especially at the Pediatric Intensive Care Unit (PICU). OBJECTIVE: To determine which are the main stressors perceived by the parents of children hospitalized at PICU and the associated variables. PATIENTS AND METHOD: A quantitative, cross-sectional and correlational study, which considers the secondary analysis of data from the IDA project # 201403 of UC School of Nursing: Validation of "The parental stressor scale infant hospitalization in Spanish" (PSSIH modified). Sampling was non probabilistic by convenience, with 217 parents of children at the PICU of a University hospital, who answered a demographic questionnaire and the modified PSSIH instrument to measure stressors in the PICU environment. RESULTS: Three dimensions of stressors were identified: Clinical, Emotional and Communication with the professional team. The clinical dimension was the most stressful, with the factors images or sounds, procedures and interventions and the aspect of the child, dimensions related to behavior and communication with the team were less stressful. In addition, it is associated with a greater perception of stress in the different dimensions, when having: previous experiences in PICU, programmed admission, admission due tocardiac pathology, single child, higher educational level and no partner. CONCLUSIONS: The modified PSSIH instrument made it possible to determine the main stressors perceived by the parents of children in the PICU, the Clinical dimension being the major stressor. These results are useful for developing local intervention programs according to the particular characteristics of the PICU.
Subject(s)
Humans , Male , Female , Infant, Newborn , Infant , Child, Preschool , Child , Adolescent , Adult , Middle Aged , Young Adult , Parents/psychology , Stress, Psychological/etiology , Intensive Care Units, Pediatric , Stress, Psychological/diagnosis , Stress, Psychological/psychology , Cross-Sectional StudiesABSTRACT
BACKGROUND: Induction chemotherapy (IC) with TPF (docetaxel, cisplatin, 5FU) for locally advanced head and neck squamous cell carcinoma (LAHNSCC) is limited to fit patients. OBJECTIVE: We conducted a retrospective cohort study to assess the use of the EXTREME regimen (platinum-based therapy, 5FU, cetuximab) as IC in frail patients with LAHNSCC. PATIENTS AND METHODS: Retrospective analysis of all consecutive patients with unresectable LAHNSCC treated with the EXTREME regimen, with or without 5FU as IC, from two French centers from 2008 to 2015. We assessed the rate of completed sequence defined as at least two cycles of IC and definitive radiation therapy. RESULTS: We included 34 patients with a median age of 56 years [44-70]. The primary site of tumor development was the oropharynx (67%, n=23, all HPV negative), hypopharynx (21%, n=7) and the oral cavity (12%, n=4). At inclusion, patients presented: T4 76, 5% (n=26), N2c 41% (n=14), N3 26% (n=9), stage disease IVa 62% (n=21), IVb 38% (n=13), ECOG PS2 38% (n=13), decreased weight (10% in one month or 15% in 6 months) 74% (n=25). The sequence was achieved for 76% (n=26) of patients and 80% (n=27) presented a clinical response after the chemotherapy course with notably increased weight (40%, n=11) or general status (75%, n=26). Median PFS and OS were 5.7 and 15.5 months, respectively. Disease progression at 3 months was significantly associated with decreased median overall survival (13.6 versus 21.9 months, p=0.01). CONCLUSION: This is the first study to report the use of the EXTREME regimen as induction chemotherapy, and although this IC was used in a very frail population, the majority completed the sequence with significant clinical benefit.
Subject(s)
Induction Chemotherapy/methods , Squamous Cell Carcinoma of Head and Neck/drug therapy , Aged , Aged, 80 and over , Female , Frail Elderly , Humans , Male , Middle Aged , Squamous Cell Carcinoma of Head and Neck/pathologyABSTRACT
BACKGROUND: Parents of children having congenital heart diseases (CHDs) develop symptoms of depression, distress, anxiety, and hopelessness more frequently than parents of healthy children. Associated with the described symptoms, parents may experience a lack of control and disempowerment, which decreases the parent's agency, a construct from development studies, and which may have negative consequences on adherence to treatment. The primary aim of this study was to assess the effect of medical treatment on well-being and agency in parents of children having CHDs, in Chile, and to compare it with reference values. METHODS: Forty parents of children having CHDs (before surgery and before hospital discharge) and 115 parents of healthy children were surveyed. The following scales were applied to this population: the General Health Questionnaire, the Basic Psychological Needs Scales, the Self-Determination Scale, the Beck Hopelessness Scale, and a socioeconomic survey. RESULTS: Children's surgery decreased parents' hopelessness (3.13 ± 0.35 and 2.18 ± 0.40, P = .04), and no significant differences were found in the remaining scales. Parents of children with CHDs scored significantly worse than parents of healthy children on the General Health Questionnaire (13.82 ± 1.03 and 9.21 ± 0.64, P = .001). This difference was not found using the others scales. CONCLUSION: Children's surgery has a positive effect on parent's hopelessness, but it does not have any impact on their well-being nor agency. Parents of children with CHD have a decreased well-being compared to parents of healthy children but have a similar level of agency. Socioeconomic level and gender may influence this association.
