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NCT07669168
The Health Ahead Comparative Effectiveness Study is a pragmatic, parallel-arm interventional platform that systematically compares successive changes to preventive health screening - each isolated as a single variable against current practice - on the path toward a fully automated screening system deployable in any environment, including the most isolated and resource-limited communities. Each comparison is evaluated with a common set of engagement, behavior-change, experience, cost, and longitudinal outcome measures, allowing results to accumulate on a consistent yardstick across the life of the platform. The first comparison evaluates static versus interactive personalized health report delivery. Subsequent pre-planned comparisons, added by protocol amendment, evaluate mobile community versus fixed laboratory screening; and a hybrid medical-droid plus human-delivery model versus human-only screening. All participants are simultaneously enrolled in the 100-Year Human Aging Study and the Human Observatory Study, contributing individual longitudinal and population-level causal inference data through those protocols.
NCT07653074
Society has become increasingly digital, and many everyday services have been replaced by digital self-service solutions. This puts greater demands on our vision and our ability to interpret what we see. At the same time, the number of children with nearsightedness (myopia) has increased rapidly. In some parts of Asia, as many as 60-70% of students in seventh grade are nearsighted (1), and a similar trend may develop in Europe. Nearsightedness is becoming a growing challenge in pediatric eye care. High myopia can lead to complications that require early detection and prevention. There are now several ways to slow down its progression, such as special contact lenses, glasses, and eye drops (2). However, the scientific evidence for these treatments varies, and there are currently no national or Nordic guidelines on how to use them. In addition, myopia may have a major impact on children's quality of life. Currently, there is no validated Swedish questionnaire that measures vision related quality of life across all age groups in children and adolescents. To address this, researchers in the United States developed the Pediatric Eye Questionnaire (PedEyeQ) in 2019 (3). It is already available in English and Spanish and takes into account both the child's and the parent's perspectives on vision and daily life. The aim of this study is to translate, culturally adapt and test the PedEyeQ in Swedish children and adolescents, and to investigate how common refractive errors, especially nearsightedness - are today compared to 20-30 years ago. The study will include 300 healthy children and adolescents aged 0-17 years, divided into three age groups: 0-4 years, 5-11 years, and 12-17 years. Participants will be recruited through child health centers, preschools, and schools in the Örebro region. All participants will visit the eye clinic for a detailed eye examination, including: * Testing distance and near visual acuity * Measuring eye refraction (with and without eye drops that temporarily relax the eye's focusing muscles) * Imaging the retina using Optical Coherence Tomography (OCT) * Measuring eye length and corneal shape * Checking eye pressure and contrast sensitivity Children and parents will also answer questions about how the child's vision affects everyday life and wellbeing. For the youngest children (0-4 years), only parents will answer the questions. The PedEyeQ will be translated into Swedish following the International Society for Pharmacoeconomics and Outcome Research (ISPOR) (4) guidelines to make sure it is culturally relevant and easy to understand. The Swedish version will then be tested to ensure it is accurate and reliable. All information collected in the study will be stored securely and anonymously. The results will also be compared with data from a similar cohort conducted in the 1990s to see if vision problems have become more common over time (5). This project will provide new knowledge about children's vision and quality of life in Sweden. A validated Swedish version of the PedEyeQ can be used both in healthcare and research to better understand how vision affects children's daily lives. The study will also offer updated information on the frequency of refractive errors among Swedish children and adolescents - knowledge that is essential for developing preventive strategies and improving eye care for the future.
NCT07648121
The observational study aims to improve understanding of Oral Health-Related Quality of Life (OHRQoL) among preschool children in the District of Portalegre, Portugal, by examining the roles of sociodemographic, behavioral, and parental psychosocial factors, as well as the child's oral health status. The study seeks to answer the following main research question: How do sociodemographic, behavioural, parental psychosocial factors, and the child's oral health status influence the Oral Health-Related Quality of Life (OHRQoL) of preschool children in the District of Portalegre?
NCT07643181
This study aims to examine the effect of a Mindfulness-Based Self-Compassion Program on self-compassion levels, secondary traumatic stress, and professional quality of life in midwives and nurses working in obstetrics. Healthcare professionals in this field are frequently exposed to traumatic experiences such as complicated deliveries, perinatal loss, and obstetric emergencies, which may lead to secondary traumatic stress and reduced professional quality of life over time. This study is designed as a pre-test/post-test randomized controlled trial. A total of 80 participants (40 intervention, 40 control) will be recruited from Gaziantep Cengiz Gökçek Obstetrics and Pediatrics Hospital. The intervention group will receive an 8-week Mindfulness-Based Self-Compassion Program (one session per week, 60-90 minutes each). The control group will receive no intervention. Outcomes will be measured before and after the program using validated scales for self-compassion, secondary traumatic stress, and professional quality of life.
NCT06355050
In this prospective, multi-center cohort study, the tolerability and quality of life during ultrahypofractionated radiotherapy (RT) of early stage prostate cancer is surveyed at several institutions in Germany. Radiotherapy is delivered by an online-adaptive RT device (Varian Ethos), which is able to correct daily variations in anatomy and to adjust the irradiation plan accordingly. A digital patient questionnaire is used to asses quality of life longitudinally. Quality of life (QoL) and toxicity profiles will be correlated with planning parameters and compared to retrospective cohorts of patients who underwent normofractionated RT or moderately hypofractionated RT, respectively.
NCT06605261
The goal of this randomized controlled trial is to evaluate the effect of a yoga program on improving the quality of life, reducing joint pain, and alleviating vasomotor symptoms (night sweats, hot flashes) in women with breast cancer undergoing endocrine therapy. The main questions it aims to answer are: Does the yoga program significantly improve the quality of life in women with breast cancer undergoing endocrine therapy? Is the yoga program effective in reducing joint pain in women with breast cancer? Does the yoga program reduce the severity of night sweats and hot flashes in women with breast cancer? Researchers will compare the intervention group, which will receive the yoga program, to the control group, which will continue with their physician-recommended routine exercise, to see if there is a difference in these outcomes. Participants will: Participants will consist of women with breast cancer undergoing endocrine therapy, with 34 in the yoga (intervention) group and 34 in the control group. Complete the;Patient Assessment Form; and the Functional Assessment of Cancer Therapy - Endocrine Symptoms (FACT-ES) scale. The intervention group will participate in a 70-minute yoga program, delivered online via a digital platform, four days a week for six weeks, led by an instructor. The control group will not receive any intervention and will continue with their physician-recommended routine exercise.
NCT07622420
In the past two decades, the evidence-based knowledge on the prevalence and risk factors for gonads impairment, including infertility, following cancer and numerous cancer treatment regimen has significantly increased. However, data remains mostly insufficient for individualized prediction of (future) fertility and pregnancy potential, including the use and success of artificial reproductive technologies (ART). Furthermore, therapies have become increasingly complex as more recent treatment regimen have continuously also implemented novel treatment approaches (e.g. immune therapies such as checkpoint inhibitors) for which no comprehensive data regarding its impact on fertility and pregnancy outcomes is available, yet. It is crucial to carefully balance risk-benefit between fertility preservation (FP) procedures and potential of gonadal function/fertility impairment, to examine the efficiency and safety, as well as to assess patients' satisfaction regarding the FP procedures. Answering these questionsis highly relevant as it has been shown that fertility capacity and post-treatment gonadal function may represent a significant part of quality of life in young cancer survivors. The study therefore aim to set up a large-scale registry of emerging data collection programmes to evaluate the gonadotoxic risks, including the prevalence and course of ovarian dysfunction and/or fertility impairment and premature ovarian insufficiency following specific treatments, identification of further risk factors and predictive markers to enhance precision survivorship research in this field. Additionally, data on the use of fertility preservation/hormonal treatment and patients' satisfaction related to these procedures in Europe will be analysed to support patient-centric care. Reproductive health counselling should not be limited to evaluating the risk of gonadotoxicity and offering fertility preservation to those at risk. It should also include evaluating the impact on post-treatment sexuality, menopausal symptoms management, and the counselling on contraception. In addition to clinical information, whole genome sequence data will be generated for selected study participants with evidence of varying impact of gonadotoxic therapies on reproductive function to find genetic variants associated with risk of reproductive and organ toxicity. The data collection will focus on all different cancer diseases, including diseases which are less common such as different types of sarcomas. This will be a significant development to the current state of information in existing registries. The primary objectives of this prospective analysis of European ongoing adolescent and young adult (AYA) cancer patient cohorts are: 1. To establish a database with relevant clinical characteristics at time of diagnosis, cancer therapy received and post-cancer clinical and reproductive outcomes by following AYA cancer patients longitudinally. 2. To evaluate the effect of cancer therapies on ovarian function and reproductive potential. 3. To evaluate fertility preservation measures performed, their risks and efficacy. 4. To evaluate the impact of fertility preservation measures on the risk of cancer relapse. 5. To evaluate occurrence of pregnancies/live births naturally conceived (including unplanned) or through medical assistance post-cancer and the obstetrical complications and neonatal health following the use of cryopreserved oocytes or gonadal tissue. 6. To set up a genetic database based on whole genome sequencing of AYAs of the cohort. For this objective a Substudy 1 : " Development of risk prediction models based on clinical and genetic data " will be conducted. 7. To develop prediction models for organ toxicities in cancer patients (objective included in Substudy 1). 8. To evaluate the effect of cancer therapies on sexuality and quality of life. For this objective a Substudy 2 : "Sexual Health" will be conducted. 9. To evaluate the use and counselling on contraception. For this objective, a Substudy 3 : "Contraception" will be conducted. 10. To describe management of treatment-induced premature ovarian insufficiency (POI) and menopausal symptoms. For this objective a Substudy 4 "Management of POI and Menopause Symptoms" will be conducted. 11. To explore patient's satisfaction receiving counseling and/or undergoing fertility preservation. For this objective a Substudy 5 on "Satisfaction with Fertility Preservation" will be conducted.
NCT05308914
Hypertension (HTN) rates have increased worldwide, but the most significant increase in the incidence of morbidity and mortality has been in African Americans (AA) (43% vs 27% for other U.S. population groups). Despite evidence of positive benefits from lifestyle modification (healthy diet, reduced sodium intake, increased physical activity, smoking cessation) and prescribed antihypertensive therapy (AHT) many AA with HTN do not adhere to their treatment regimens. Consistent, effective lifelong self-management is required to sustain optimal BP control and thus reduce morbidity and mortality. Self-managing HTN to a blood pressure (BP) \<130/80 mm Hg presents challenges such as juggling multiple medications and health care providers, dealing with complex recommendations and treatment regimens, and coping with negative emotional states. Few studies have examined the biopsychosocial mechanisms that foster effective HTN self-management and resilience among AA living with HTN. Understanding the mechanisms that influence HTN self-management and resilience in AA holds the promise of new modifiable targets for behavior-change interventions. This study explores the relationship among resilience precursors on hypertension (HTN) self-management behaviors, stress response, and the effects that these relationships have on health outcomes-health-related quality of life (HRQOL) and blood pressure (BP) in African Americans (AA) with HTN over a 6-month period.
NCT06791967
Heart disease is the second leading cause of death in Taiwan, with approximately 700,000 individuals affected by heart failure. Despite the proven benefits of rehabilitative exercise, participation in cardiac rehabilitation remains suboptimal. To address this, integrating physical activity into daily life, such as home-based walking exercises, offers a practical alternative to promote health and improve outcomes in heart failure patients. Walking exercises have been shown to significantly impact mortality rates and enhance the quality of life in this population. This study aims to assess the effects of a 12-week home-based walking exercise program on depression, frailty, and quality of life in patients with heart failure. Using an experimental design, heart failure patients hospitalized in a medical center's internal medicine ward were randomly divided into an experimental group (n=34) and a control group (n=34). While both groups received standard health education, the experimental group also participated in a home-based walking intervention after discharge. Data were collected before the intervention and at the 1st and 3rd months post-intervention. The generalized estimation equation (GEE) was employed to analyze changes in depression, frailty, and quality of life, focusing on group differences and interactions between time and group. The expected outcomes of the study include improved quality of life, reduced frailty, and alleviated depression in the experimental group, highlighting the value of home-based walking exercise. Additionally, the intervention model can complement existing post-discharge nursing practices by incorporating remote nursing guidance to enhance exercise adherence without increasing healthcare costs. This approach not only benefits patients by encouraging long-term physical activity but also reduces the burden on healthcare systems, making it a sustainable and effective strategy for managing heart failure.
NCT06141798
As Korea is becoming a super-aged society, the number of elderly patients with end-stage kidney disease (ESKD) is expected to increase rapidly. Therefore, the burden on Korean society will also increase. Thrice-weekly hemodialysis is standard for renal replacement therapy. However, this regimen has not been validated for elderly ESKD patients with residual renal function. Elderly patients can have multiple comorbidities such as hypertension, diabetes, cardiovascular disease, and impaired physical activity. Frequent hemodialysis could provoke falls, hypotension, and cognitive impairment. Previous reports have suggested the potential benefit of twice-weekly hemodialysis with incremental increases in frequency when residual renal function decreases. In addition, twice-weekly hemodialysis decreases hospitalization rates in frail patients. Therefore, the investigators hypothesized initiating renal replacement therapy with twice-weekly hemodialysis decreases the hopsitalizatoin rates compared with conventional thrice-weekly hemodialysis in elderly ESRD patients with residual renal function. This study is a pragmatic randomized clinical trial, multicenter study. Study subjects are incident ESRD patients (\>= 60 years old, n=428) with residual urine volume ( \> 500 mL/day) and follow up up to 2 years. Twice-weekly hemodialysis could be incremented according to clinical situations such as volume overload, hyperkalemia and uremic symptom. Primary outcome of this study is hospitalization rate during follow-up. Secondary outcomes include dialysis related hospitalization rate, the length of hospital stay, complication of dialysis,mortality rate and assessments of quality of life, frailty, and cost-utility.
NCT05685368
The current study seeks to build on previous research that demonstrates the efficacy of Acceptance and Commitment Therapy in combating stigma by investigating the feasibility and acceptability of a protocol to support Black adolescents and young adults in coping with race related stress. The study will consist of a small, purposeful, non-randomized sample (N = 30) of clients enrolled into a 10-session Acceptance and Commitment Therapy group. The group will be offered as part of regular clinical care at the Division of Adolescent and Young Adult Medicine. Three consecutive groups will be run with approximately 8-10 participants in each group over the next year.
NCT06584734
Introduction: Cardiovascular disease is the leading cause of morbidity and mortality in patients undergoing hemodialysis, largely due to structural cardiac changes associated with left ventricular diastolic dysfunction. In addition, this population has a high prevalence of sedentary behavior, which has been associated with increased mortality. Recent studies in patients with chronic kidney disease have shown that structured exercise interventions improve several parameters related to cardiovascular health. Objectives: To evaluate the effect of implementing systematic intradialytic exercise on left ventricular diastolic function. Materials and Methods: This will be a quasi-experimental before-and-after study conducted in two phases. During the first phase (control), prevalent hemodialysis patients will receive standard treatment for 16 weeks. Transthoracic echocardiography will be performed at baseline and repeated at the end of this phase to assess left ventricular diastolic function parameters. During the second phase (intradialytic exercise), participants will undergo a 16-week supervised and prescribed intradialytic aerobic exercise program consisting of intradialytic cycling. Exercise intensity will be individualized according to cardiopulmonary exercise testing (CPET), which will be performed at the beginning and end of this phase. A final echocardiogram will be obtained at the end of the intervention phase. In addition, a 6-minute walk test and a validated physical activity questionnaire will be administered monthly throughout both phases of the study.
NCT04444544
The investigators plan to measure the changes of health-related quality of life (HRQoL) at 6 months and 12 months after the following high-risk oncological abdominal surgery: gastrectomy, esophagectomy, pancreatectomy and hepatectomy. The investigators will measure the HRQoL using the validated EORTC QLQ-C30 questionnaire before and at 6 months and 12 month after the surgery. The investigators will identify phenotypes of HRQoL changes (improvement, stability and deterioration) at 6 months and 12 months after surgery. The second aim is to assess the regret of the patient at 6 months and 12 months regarding his/her decision to undergo surgery. The investigators will also assess the regret of the next of kin at 6 months regarding the decision to undergo surgery. This descriptive, prospective, observational, single-centre cohort study aims to: identify phenotypes of HRQoL changes after abdominal surgical oncology (improvement, stability and deterioration); assess the regret of patients regarding their decision to undergo surgical oncology at 6 months and 12 months; assess the regret of the next of kin regarding the decision of the patient to undergo surgical oncology at 6 months and 12 months. The investigators will include patients scheduled for the following elective abdominal cancer surgery: gastrectomy; esophagectomy; pancreas resection and hepatectomy. The investigators will assess HRQoL using the validated EORTC QLQ-C30 Summary Score before and 6 months and 12 months after surgery. The cut-offs for the three phenotypes of HRQoL changes will be defined using the minimal clinically important difference (MCID) of 10 points. The investigators will assess regret using the Decision Regret Scale (DRS) at 6 months and 12 months after surgery. The expected results are: The investigators can identify phenotypes of HRQoL changes after surgical oncology using the EORTC QLQ-C30 Summary Score; the investigators will describe the distribution of these phenotypes and will find an association with the pre-existing frailty. The investigators can describe the extent of the regret of the patient and of the next of kin at 6 months using the DRS. The investigators will observe an association between the DRS score at 6 months and the HRQoL Summary Score change. The investigators will not observe a relationship between the DRS score of patients and next-of-kins.
NCT07480668
The experience of infertility can cause significant emotional instability, especially for patients awaiting In Vitro Fertilization (IVF) treatment, generating anxiety, stress, and depressive symptoms. This study is a randomized clinical trial assessing the effectiveness of aromatherapy in improving mental health and quality of life in women undergoing infertility treatment. 120 participants will be randomized into three groups (Intervention, Placebo, and Control). The intervention involves the inhalation of true lavender essential oil (Lavandula angustifolia) for four weeks.
NCT07248111
This randomized controlled trial aims to evaluate the effectiveness of the Mindful Compassion Care Program (MCCP), a mindfulness- and compassion-based intervention designed to enhance the emotional and professional well-being of healthcare professionals (HPs). The study adopts a multi-center, open-label, randomized, parallel-group, superiority design and includes HPs (physicians, nurses, and nursing assistants) involved in the clinical care of cancer patients across different settings and disease phases. Eligible participants must not have attended MBSR or other mindfulness-/compassion-based interventions in the preceding six months. The RCT has a primary objective of assessing the MCCP's effectiveness in increasing positive emotions and reducing negative emotions among HPs working in oncology and palliative care. Secondary objectives include evaluating improvements in professional quality of life and self-compassion. After providing informed consent, HPs will be randomized to receive either the MCCP (experimental group) or no intervention (control group).
NCT07551817
This study will be conducted in a randomized controlled experimental design to examine The effect of art-based intervention on fatigue, anxiety, perception of nurse presence, and quality of life in patients with hematological cancer. The study will be conducted with 52 patients (26 intervention, 26 control groups) treated in the Hematology department of a training and research hospital between May 2025 and October 2026. Art-based intervention will be applied to the intervention group for 2 week (3 sessions per week), No application will be made to the control group. The data collection tools in the study are the Patient Identifier Information Form, Cancer Fatigue Scale, Functional Assessment of Cancer Therapy-General Scale (FACT-G), Hospital Anxiety and Depression Scale (HADS), and Nurse Presence Scale (PONS).
NCT06923358
Rationale and Objectives: Despite significant efforts from healthcare professionals, nursing home residents with dementia often face isolation and a reduced quality of life. Increasing attention has been given to digital solutions as a complement to pharmaceutical treatments. In particular, Virtual Nature (VN; i.e., virtual reality simulations that simulate nature experiences) has emerged as a promising, cost-effective approach to enhancing quality of life and slowing cognitive decline in nursing home residents with dementia. This project aims to assess the long-term effects of a VN intervention on various health and well-being indicators in nursing home residents with dementia. Design: The study will be conducted as a randomized controlled trial with parallel conditions. Participants will be randomly assigned to either a treatment or a control group. The treatment group will undergo a 12-week VN intervention in addition to usual medications and nursing home activities, while the control group will continue with their usual medications and activities. Assessments will be performed at baseline, in concomitance with the first VN session, and at 4 and 12 weeks into the intervention. VN intervention: The intervention will consist of undergoing a 10-minute VN session twice a week for 12 consecutive weeks. The participants will choose a 360° video from a library of different VN scenarios. The 360° videos within the library will be filmed by the researchers in locations near or in the same region of the participant's nursing homes, and will consist of scenes from various seasons in Norway (spring, summer, fall, winter) and depict popular outdoor recreations such as hiking and cross-country skiing. The VN sessions will be delivered in the participants' room. The playback will be done through a Meta Quest 3 (Reality Labs , USA). The intervention will be delivered by the researchers in collaboration with caregivers and/or nursing students in practice. Participants: Sixty nursing home residents with dementia will be recruited from different nursing homes in Drammen municipality and randomly assigned to the treatment or the control condition. The treatment group will undergo the VN intervention while continuing to receive their usual medications and attending regular activities at their respective nursing homes. The control group will only continue receiving their usual medication and attending regular activities at their respective nursing homes. Inclusion criteria are: being a nursing-home resident with a dementia diagnosis, having normal or corrected-to-normal sight and being able to communicate in Norwegian. Additionally, participants will be excluded if deemed to have poor tolerance to the VN experience (this will be evaluated based on preliminary trials and discussions with caregivers). Written informed consent will be collected for all participants (either directly from the participant or, in case they are not legally competent, their caregivers), after having explained the benefits and risks of participating to them. Instruments: Basic demographic data (age and gender) will be recorded. To assess potential long-term effects, the following measures will be collected at baseline, week 4, and week 12 for both the treatment and control groups: Quality of Life in Late-stage Dementia scale, Cornell Scale for Depression in Dementia, Brief Agitation Rating Scale, Clinical Dementia Rating scale, and Use of psychotropic drugs.
NCT05883540
Background: Terminally ill patients often experience significant psychosocial distress having depressed mood, death anxiety, pain, and an overall poor quality of life. Recent evidence from pilot studies suggests that serotonergic hallucinogens including lysergic acid diethylamide (LSD) and psilocybin produce significant and sustained reductions of depressive symptoms and anxiety, along with increases in quality of life, and life meaning in patients suffering from life-threatening diseases. Additionally, serotonergic hallucinogens may produce antinociceptive effects. Objective and Design: The study aims to evaluate effects of LSD on psychosocial distress in 60 patients suffering from an advanced or end-stage fatal disease with a life expectancy ≥12wks and ≤2yrs in an active placebo-controlled double-blind parallel study. Patients will be allocated in a 2:1 ratio to one of the two intervention arms receiving either two moderate to high doses of LSD (100 µg and 100 µg or 100 µg and 200 µg) as intervention and two low doses of LSD (25 µg and 25 µg) as active-placebo control.
NCT07546435
Several international studies indicate that men with reduced semen quality often feel overlooked in the context of fertility treatment. Men who undergo fertility treatment due to their own infertility, exhibit increased concern and experience more negative emotions such as loss, stigmatization, and low self-esteem - more so than men undergoing fertility treatment for other reasons. Since 2008, there has been limited research on the experiences of male patients with infertility in Denmark. Furthermore, there is generally very little knowledge regarding the testosterone levels (hypogonadism) of male infertile patients and its association with quality of life. Thus, there is a lack of updated insight into how infertile men experience their situation today. Additionally, the present study finds it relevant to examine whether men's needs and experiences in interactions with health professionals have changed over the past 15 years.
NCT06160986
This research is being done to evaluate the feasibility of the Horizons Program, a group-based behavioral intervention, to enhance quality of life in patients with chronic graft-versus-host disease.