scholarly journals Effects of a Self-Monitoring Quality of Life Intervention for Patients with Cancer Receiving Palliative Care in Japan: Study Protocol for a Randomized Controlled Trial

2018 ◽  
Vol 19 (11) ◽  
pp. 3027-3032 ◽  
Author(s):  
Ayako Matsuda ◽  
Yosuke Yamada ◽  
Noriko Ishizuka ◽  
Eisuke Matsushima ◽  
Kunihiko Kobayashi ◽  
...  
2021 ◽  
Vol 9 ◽  
Author(s):  
Covadonga M. Díaz-Caneja ◽  
Javier Martín-Babarro ◽  
Renzo Abregú-Crespo ◽  
Miguel Á. Huete-Diego ◽  
Marta Giménez-Dasí ◽  
...  

Introduction: Bullying is a major preventable risk factor for mental disorders. Available evidence suggests school-based interventions reduce bullying prevalence rates. This study aims to test the efficacy of a web-enabled, school-based, multicomponent anti-bullying intervention to prevent school bullying and to assess its effects on mental health and quality of life.Methods and analysis: Cluster randomized controlled trial conducted in 20 publicly funded primary and secondary schools in Madrid, Spain. Schools are randomly allocated to either the intervention arm (n = 10) or conventional practices arm (n = 10). The web-enabled intervention (LINKlusive) lasts ~12 weeks and consists of three main components: (i) an online training program for teachers and parents, (ii) a web-guided educational program for students, focusing on promoting respect for diversity, empathy, and social skill development, and (iii) a web-guided, teacher-delivered, targeted intervention program for bullying situations identified based on peer-support strategies and individual intervention for those involved (i.e., bullying victims and perpetrators). The primary objective is to compare differences between peer-reported bullying victimization in the intervention and control arms at the end of the intervention. Secondary outcome measures are additional measures of bullying victimization and perpetration, mental health symptoms, self-esteem, and quality of life. A follow-up assessment is conducted 1 year after the end of the intervention. Treatment effects will be tested using multilevel mixed models, adjusting for school-, classroom-, and student-related covariates. Considering the increased bullying rates in children with special educational needs, a specific subgroup analysis will test the efficacy of the intervention on bullying prevalence, mental health, and quality of life in this particularly vulnerable population.Ethics and Dissemination: The Deontology Commission of the School of Psychology, Universidad Complutense in Madrid, Spain reviewed the study protocol and granted ethical approval on 21st January 2019. The results of the trial will be disseminated in relevant peer-reviewed journals and at conferences in the field.Trial Registration Number: ISRCTN15719015.


Trials ◽  
2012 ◽  
Vol 13 (1) ◽  
Author(s):  
Paulo de Tarso Camillo de Carvalho ◽  
Ernesto Cesar Pinto Leal-Junior ◽  
Ana Carolina Araruna Alves ◽  
Caroline Sobral de Melo Rambo ◽  
Luciana Maria Malosa Sampaio ◽  
...  

2019 ◽  
Vol 18 (1) ◽  
Author(s):  
Anouk S. Schuit ◽  
Karen Holtmaat ◽  
Nienke Hooghiemstra ◽  
Femke Jansen ◽  
Birgit I. Lissenberg-Witte ◽  
...  

Abstract Background Patients with incurable cancer have to deal with a wide range of symptoms due to their disease and treatment, influencing their quality of life. Nowadays, patients are expected to adopt an active role in managing their own health and healthcare. Oncokompas is an eHealth self-management application developed to support patients in finding optimal palliative care, tailored to their quality of life and personal preferences. A randomized controlled trial will be carried out to determine the efficacy and cost-utility of Oncokompas compared to care as usual. Methods 136 adult patients with incurable lung, breast, colorectal and head and neck cancer, lymphoma and glioma, will be included. Eligible patients have no curative treatment options and a prognosis of at least three months. Patients will be randomly assigned to the intervention group or the control group. The intervention group directly has access to Oncokompas alongside care as usual, while the waiting list control group receives care as usual and will have access to Oncokompas after three months. The primary outcome measure is patient activation, which can be described as a patient’s knowledge, skills and confidence to manage his or her own health and healthcare. Secondary outcome measures comprise self-efficacy, health-related quality of life, and costs. Measures will be assessed at baseline, two weeks after randomization, and three months after the baseline measurement. Discussion This study will result in knowledge on the efficacy and cost-utility of Oncokompas among patients with incurable cancer. Also, more knowledge will be generated into the need for and costs of palliative care from a societal and healthcare perspective. Trial registration Netherlands Trial Register identifier: NTR 7494. Registered on 24 September 2018.


PLoS ONE ◽  
2019 ◽  
Vol 14 (6) ◽  
pp. e0219065 ◽  
Author(s):  
Toshitaka Morishima ◽  
Isao Miyashiro ◽  
Norimitsu Inoue ◽  
Mitsuko Kitasaka ◽  
Takashi Akazawa ◽  
...  

Trials ◽  
2014 ◽  
Vol 15 (1) ◽  
Author(s):  
Kristian Hillert Winther ◽  
Torquil Watt ◽  
Jakob Bue Bjørner ◽  
Per Cramon ◽  
Ulla Feldt-Rasmussen ◽  
...  

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