Study protocol of a proposed Neurofeedback-Assisted Mindfulness Training Program on symptoms of anxiety and psychological distress associated with smartphone use in young adults: a randomized controlled trial.

Background: Nomophobia is a specific phobia characterized by the appearance of anxiety, nervousness, discomfort and distress when the mobile phone is not used and is considered an emerging public health problem because of the negative consequences on the physical and mental health of young people and adolescents, especially women. Neurofeedback-Assisted Mindfulness Training Programs may prove beneficials for improving self-control abilities, a key ability in addressing addictive behaviors. The main objective of this study is to evaluate the impact, in a young population aged 18-35 years, of an intervention based on Neurofeedback-Assisted Mindfulness Training Program (NAMTP) on disorders associated with problematic use of mobile phones. The effect of the intervention on the total score in the nomophobia test and habits of internet and social network use, as well as on signs of depression, anxiety and stress will be analyzed. As a secondary objective, the effect of the intervention on signs of insomnia will be analyzed. Methods and design: Randomized, controlled clinical-trial with two-parallel groups. 40 young adults (18-35 years) will be included and randomly assigned to Intervention Group-NAMTP or Control Group (CG). The NAMTP will include a total of 25 sessions (2-3/week) during 3-months. Each session will have a duration of 10/15 min. The instrument to be used for the neurofeedback sessions is MUSE® (InteraXon Inc.). Study variables will be collected at the baseline visit and at the final visit (3-months after randomization). During these visits, questionnaires will be administered to evaluate the main and secondary variables that will include the Smartphone Addiction Scale-Short Version, Nomophobia Questionnaire, Depression, Anxiety and Stress Scale 21-item (DASS-21) and Athens Insomnia Scale. Discussion: This trial will make an important contribution to the need for evidence of effective education programs and other primary care interventions through new non-invasive interventions in reducing the risk of developing addictions to new technologies and alleviating the symptoms of discomfort associated with this problem. Ethics and dissemination: The project was approved by the Clinical Research Ethics Committee of the Salamanca Health Area (CEIm Code: PI 2023 071340). Clinical trial registration: ClinicalTrials.gov, http://www.Clinicaltrials.gov/ct2/show/NCT06188910.

Study on the additional financial burden of breast cancer disease on cancer patients and their families. Financial toxicity in cancer.

Introduction: Breast cancer is among the most frequently diagnosed cancers worldwide, with 2.3 million new cases reported annually. The condition causes a social and economic impact known as financial toxicity of cancer. The study aims to explore the extra expenses borne by patients and their families on being diagnosed with breast cancer. Methodology: An observational, descriptive, cross-sectional study was conducted. The data was collected between November 2021 and March 2022 at the Medical Oncology Service in Complejo Asistencial Universitario de Salamanca, Spain. The variables under investigation were additional economic costs, physical disability (as measured by the Barthel Index), instrumental activities of daily living (as measured by the Lawton-Brody Scale), and caregiver burden (measured using the ZARIT scale). Results: The final sample size was N = 107. The study yielded the following outcomes: the median age was 55 years old and the majority of participants were female, with a proportion of 99.1%. The incidence rates for stage I and II were 31.8 and 35.5%, respectively. The median Barthel score was 100 points, while the Lawton and Brody score were 8 points and the ECOG score was 2 points. The analysis of primary caregiver burden resulted in a median ZARIT score of 15 points. The expenses related solely to the cancer diagnosis totaled 1511.22 euros per year (316.82 euros for pharmaceuticals; 487.85 euros for orthopedic equipment; 140.19 euros for home help; and 566.36 euros for housing adaptation or transfer to a hospital). The average annual income before diagnosis was 19962.62 euros. However, after being diagnosed with breast cancer, there is a significant income decrease of 15.91%, resulting in a reduced average annual income of 16785.98 euros. Additionally, a significant correlation was found between total expenditure and the level of dependency (p = 0.032) and functional status (p = 0.045). Conclusion: These findings indicate that breast cancer patients experience a considerable economic burden, which worsens as their functional status deteriorates. Therefore, we believe policies should be implemented to help control this economic deterioration resulting from a serious health condition.

Multimodal Physical Exercise and Functional Rehabilitation Program in Oncological Patients with Cancer-Related Fatigue-A Randomized Clinical Trial.

The increase in life expectancy and survival time implies an increase in the possible side-effects of pharmacological treatments in patients. Cancer-related fatigue is one of these side-effects. The main objective of this study was to evaluate the effects of a multimodal program of physical exercise and functional rehabilitation on asthenia, pain, functional capacity, and quality of life in cancer patients with cancer-related fatigue. METHODS: This was a randomized, parallel-controlled clinical trial, with two arms (experimental and control group), and it was conducted over the course of a year in the Oncology Hospitalization Unit at the University Hospital of Salamanca, Spain. Participants (n = 48) were assessed at three points during the study. The first assessment was prior to hospital discharge, the second assessment was after 15 days, and the final assessment was at one month post-hospital follow-up. The intervention lasted one month. The main variables studied were the dependency levels (Barthel), cancer-related fatigue (FACT-An), health-related quality of life (EuroQoL-5D), functional capacity (SPPB), and kinesiophobia (TSK-F). RESULTS: Sample size (n = 44). Mean age 63.46 ± 12.36 years. Significant differences between control and experimental group participants in Barthel, FACT-An, TSK-F, and SPPB scores at follow-up and final assessment. CONCLUSIONS: There are beneficial effects of a multimodal physical exercise and functional rehabilitation program in improving the autonomy of cancer-related fatigue patients.

Analysis of the determinants of sleep quality in a Spanish population: a study protocol for a cross-sectional study.

INTRODUCTION: Sleep problems are a growing public health concern being related, among others, to an increased risk of cardiovascular diseases or worse cognitive functioning. In addition, they can affect aspects related to personal motivation and quality of life. However, very few studies have analysed the possible determinants of sleep quality in the adult population as a whole, establishing patterns based on these determinants.The objectives are to evaluate the determinants of sleep quality in a representative sample of the general adult population between 25 and 65 years old, and to establish patterns of sleep quality based on lifestyles, psychological factors, morbidities, sociodemographic variables, biological markers and other possible determinants. METHODS AND ANALYSIS: Descriptive observational cross-sectional study. The study population will include a representative sample of 500 people between 25 and 65 years old from the cities of Salamanca and Ávila (Spain) selected by random sampling stratified by age groups and sex. A 90-minute visit will be performed, during which sleep quality will be assessed. The variables collected will be: morbidity, lifestyles (physical activity, diet, toxic habits), psychological factors (depression, stress, occupational stress and anxiety), socioeconomic and work-related variables, habitability conditions of the habitual residence and rest area, screen time, relaxation techniques and melatonin as a biological marker related to sleep quality. DISCUSSION: With the results of this work, improved interventions for behaviour modification could be designed, as well as intervention and education programmes or other research aimed at improving sleep quality. ETHICS AND DISSEMINATION: This study has a favourable opinion from the Ethics Committee for Drug Research of the Health Areas of Salamanca and Ávila (CEim Code: PI 2021 07 815). The results of this study will be published in international impact journals of different specialties. TRIAL REGISTRATION NUMBER: NCT05324267.

Effect of including a dietary supplement of raisins, a food rich in polyphenols, on cognitive function in healthy older adults; a study protocol for a randomized clinical trial.

BACKGROUND: Polyphenols have been shown to be effective against many chronic diseases, including neurodegenerative diseases. Specifically, the consumption of raisins, being a food rich in polyphenols, has been attributed with neuroprotective benefits. Therefore, our main objective is to evaluate the effect of including 50 g of raisins in the diet daily for 6 months, on the improvement of cognitive performance, cardiovascular risk factors and markers of inflammation in a population of older adults without cognitive impairment. METHODS: Design and intervention: This study will be a randomized controlled clinical trial of two parallel groups. Each subject included in the study will be randomly assigned to one of two study groups: control group (no supplement), intervention group (50 g of raisins daily during 6 months). STUDY POPULATION: The participants will be selected by consecutive sampling in the Primary Care consultations of urban health centers in Salamanca and Zamora (Spain), taking into account the selection criteria. STUDY VARIABLES: Two visits will be made, baseline and at 6 months. Cognitive performance will be evaluated (Mini-Mental State Examination test, Rey Auditory Verbal Learning Test, verbal fluency and montreal cognitive assessment (Moca)). It will also be analyzed the level of physical activity, quality of life, activities of daily living, energy and nutritional composition of the diet, body composition, blood pressure, heart rate, markers of inflammation and other laboratory tests of clinical relevance (glycaemia, total cholesterol, HDL cholesterol, LDL cholesterol and triglycerides). In addition, sociodemographic data, personal and family history, medication use and alcohol and tobacco consumption will be collected. DISCUSSION: In this project, it is intended to contribute to minimize the problems derived from cognitive deterioration in older people. TRIAL REGISTRATION: ClincalTrials.gov Identifier: NCT04966455 Registration date: July 1, 2021.

Study on the Socio-Economic Impact of Cancer Disease on Cancer Patients and Their Relatives.

BACKGROUND: Cancer is one of the most relevant social and health problems in the world. The disease entails additional costs for cancer patients and their families that are not covered by the public part of our welfare state, and which they assume themselves simply because they are ill. The main objective of this study is to identify and analyse the additional cost and socioeconomic impact of cancer disease on patients diagnosed with cancer disease and their families. METHODS: Descriptive cross-sectional randomised observational epidemiological study without replacement with prevalence of cancer disease in the study base, carried out in the Medical Oncology Service of the Complejo Asistencial Universitario de Salamanca (CAUSA), Spain. RESULTS: The study variable has been the additional cost of the cancer disease for cancer patients and their families that is not covered by our autonomous health system. CONCLUSIONS: Cancer disease entails an additional cost for the patient and family; more specifically, for 55% of the patients in the study sample, the diagnosis of cancer represents extra expenditure of between 8.38-9.67% of their annual income. Furthermore, the disability and dependence of patients does not represent an additional cost due to their levels of functionality, but it can have repercussions on the future cost of the evolution of the disease, in addition to the fact of having cancer.