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Showing 1-20 of 24 trials
NCT05958316
Determine the effects of the Computerized Symptom Assessment Tool (C-SCAT) versus usual care on the primary outcomes of self-efficacy for symptom management and symptom self-management behaviors
NCT07415564
The protocol will include a 10-week Symptom Management and Survivorship Handbook (SMSH) intervention to address informational needs for the management of physical and psychological symptoms, bundled with telephone delivered health coaching to address their symptom interference with physical, psychological and social functioning. The SMSH intervention, which includes both symptom assessment and management, is simple to implement, scalable, and evidence-based will be delivered to all survivors and caregivers (dyads) in this study, and will serve as an active control. In addition to the SMSH, intervention arm dyads will receive health coaching to address symptom interference and reduce social isolation. Symptom burden is more pronounced in marginalized populations such as Latina/o, rural, older age survivors and their caregivers.18-20 Many health disparities in these populations are underwritten by social isolation due to lack of access, disconnection from linguistically competent health care, mobility, and geographic proximity,21-23 and health coaching can address these issues. The specific aims of the proposed feasibility study are to determine among survivors with metastatic or stage IV cancer and their caregivers (dyads): Aim 1: Demonstrate SMSH plus health coaching feasibility (recruitment, retention, satisfaction (acceptability and appropriateness) for cancer survivors and their caregivers. Benchmarks: Recruitment 70% approached, Retention 75%, and participant satisfaction through qualitative exit interviews in week 11. Aim 2: Collect preliminary data for the intervention impact on whether the SMSH + health coaching results in lowered burden of 24 symptoms (primary outcome) over weeks 1-10, and improved HRQoL (social, physical, psychological) (secondary outcome) at week 11, compared to SMSH alone. Aim 3. Examine the enactment of self-management strategies in SMSH+health coaching versus SMSH alone. The proposed pilot trial will provide proof of concept for the SMSH coupled with a live telephone delivered health coaching intervention to improve symptom management and HRQoL for metastatic breast, GI, and melanoma cancer survivors and caregivers. By addressing physical and psychological symptoms and survivorship using scalable, accessible interventions delivered via telephone, within reach of traditionally underserved populations, the findings have the potential to lay the foundation for the dissemination and implementation of a practical solution to meet survivor-caregiver needs both locally and nationally.
NCT07233460
This double-blind, randomized controlled trial investigated the effect of bitter melon, blueberry, and cranberry powder extract use on glycemic control and diabetes symptom levels in individuals with T2DM.
NCT06136221
Remote healthcare monitoring for cirrhosis has shown promise in overcoming barriers to accessing specialty care, improving healthcare quality, and reducing mortality. The LiverWatch study is investigating whether a remote nutrition, physical activity, and education intervention can improve health outcomes in those with cirrhosis. In this clinical trial, individuals will be randomized to either enhanced usual care or the LiverWatch intervention. Both groups are given fitbits and asked to increase their step counts. Those in the Liverwatch group will be incentivized for increase their physical activity while also undergoing a personalized nutrition intervention and weekly symptom monitoring and cirrhosis education.
NCT06221436
This study aims to examine the effect of olfactory mental imagery on physiological parameters, anxiety and symptoms after cardiovascular surgery. This study was planned to be conducted as a prospective randomized controlled study in the Cardiovascular Surgery service of Istanbul Mehmet Akif Ersoy Thoracic and Cardiovascular Surgery Training and Research Hospital. The universe of the research; It will consist of patients who are hospitalized in the cardiovascular surgery service and who have undergone cardiovascular surgery. The sample will consist of a total of 90 patients hospitalized in the Cardiovascular Surgery service of the same hospital and meeting the inclusion criteria for the study. Patient Diagnosis Form, Physiological Parameters Monitoring Form, State Anxiety Inventory and Cardiac Surgery Symptom Inventory will be used to collect data. Data will be collected on days 1, 2, 3 and 4 after surgery. In the study, patients will be divided into two groups: intervention (n = 45) and control (n = 45). The intervention group will perform breathing exercises with the olfactory mental imagery technique.
NCT04433650
Introduction: Person-centred care is based on the assumption that every person has resources that should be used in the care situation. In order for this to happen the patient has to be able to effectively communicate his/her symptoms. This protocol describes the analysis of a digital picture-based tool for communication support for children with cancer aged 5-17 years, who undergo high-dose methotrexate treatment. The advantage of a non-linguistic based platform, beside the expected clinical outcomes, is that it can be used in multiple national studies with minimal translation. Methods and analysis: Two studies will be conducted in a hybrid design, i.e., a crossover design will be used for the intervention (effects), and a mixed-methods design will be used for the process evaluation. Qualitative interviews will be carried out with children with cancer, their legal guardians and case-related healthcare professionals as part of the process evaluation. The interviews will address the experiences of the intervention and frequency of use from the child's perspective. Interview transcripts will be analyzed qualitative descriptively. The digital communication tool will collect child self-reports of symptoms/emotions. The children will be monitored for biomarkers of stress and pain (neuropeptides, neurosteroids and peripheral steroids) in venous blood samples, in-app estimation levels for the children, drug consumption. Person-centeredness will be evaluated with the questionnaire Visual CARE Measure. Ethics: Ethical approval was obtained from the Swedish Ethical Review Authority (ref 2019-02392; 2020-02601).
NCT04584775
In this clinical trial we want to investigate the clinical benefit of a complementary therapy using therapeutical modalities of the traditional chinese medicine in patients suffering from advanced cancer.
NCT06215339
This study determined the effect of dietary education given to hemodialysis patients on dietary treatment and symptoms.
NCT04940780
The use of complementary and integrative medicine (CIM) among oncology patients is widespread, with a large body of research-based evidence supporting the ability of these therapies to alleviate symptoms related to cancer and its treatment. Organizations such as the American Society for Clinical Oncology and the European Society for Medical Oncology have included CIM modalities in their treatment guidelines, and many of today's leading cancer centers include CIM in their supportive care service. The proposed study will prospectively examine the impact of a CIM treatment program on the symptom burden, quality of life and function of patients undergoing active oncology treatment. A total of 750 patients will undergo an integrative oncologist (IP) consultation followed by a series of 8 CIM treatments consisting of either acupuncture or touch-related therapies (reflexology, Shiatsu, Tuina, etc.) with the goal of relieving their symptoms. Patients will be allocated to one of the two study treatment arms: the "Patient-Preference Arm", for patients who specify their preference for either acupuncture or touch therapy; and the "Randomized Treatment Arm", for those with no preference, to be randomly allocated to either the acupuncture or touch-therapy subgroup. Patients will be asked to complete the following study questionnaires before and after the treatment regimen: the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30); the Edmonton Symptom Assessment System (ESAS); and the Measure Yourself Concerns and Wellbeing (MYCAW) tool. The primary study outcome will be the change in EORTC Global Health-Status / Quality of Life scores, from pre- to post-treatment. Secondary study outcomes will include EORTC QLQ-C30 functional and symptom scales, single items assessing additional symptoms commonly reported by cancer patients, and perceived financial impact of the disease; ESAS severity scores for 10 quality-of life related items; and MYCAW severity scores for the 2 most significant symptoms, as well as post-treatment narratives. Other secondary outcomes to be assessed include the safety of the study treatments (adverse effects); adherence to conventional treatment regimen; and narratives from the patient's informal caregiver (spouse, parent/child, sibling, friend, etc.).
NCT05886829
The goal of this clinical trial is to examine the effectiveness of intranasal-administered Chlorpheniramine Maleate in COVID-19-positive participants as part of early treatment for COVID-19. The main questions it aims to answer are: * To assess the efficacy of nasal spray with Chlorpheniramine (0.4%) for improving clinical recovery in COVID-19 patients. * To assess the efficacy, safety, and tolerability of nasal spray with Chlorpheniramine (0.4%) as an adjunct to the standard of care in reducing hospitalizations and improving clinical recovery in adult patients with mild COVID-19.
NCT05837988
Through a cross-sectional questionnaire survey, a general information questionnaire and Dialysis Frequency, Severity, and Symptom Burden Index were used to investigate the frequency, severity, and degree of symptom distress in MHD patients, and to analyze the differences in symptom distress status between long and short dialysis age MHD patients. Using the R 4.2.2 software qgraph package, construct symptom networks for MHD patients of long and short dialysis age through network analysis. Analyze network centrality indicators, including intensity, closeness centrality, and mediation centrality, to identify core symptoms and compare if there are any differences between the two groups, aiming to lay the foundation for precise and efficient phased symptom management.
NCT05729217
The goal of this observational study is to learn about in children aged 6-18 years, after the acute phase of SARS-CoV-2 infection, the COVID symptoms or Long COVID symptoms to impact their daily activities. We aimed to investigate the prevalence of long-lasting symptoms, the duration and intensity of symptoms, quality of life, number of sick days or absences from school, and psychological and social outcomes. The participants will be asked to fill in Long COVID symptom burden questionnaires who had been infected with SARS-CoV-2 as self-reported PRC test or antigen test positive.
NCT04873349
Starting from December 2019, novel coronavirus disease 2019 (COVID-19) pandemic has caused a tremendous economic loss and unprecedented health crisis across the globe. Discovering an effective and safe drug candidates for the treatment of COVID-19 and its associated symptoms became a global urgent demand especially due to limited data that have been released regarding the vaccine efficacy and safety in humans. Reviewing the recent research, Olive leaf was selected as a potential co-therapy supplement for the treatment and the improvement of clinical manifestations in COVID-19 patients. Olive leaves reported to be rich in phenolic compounds such as oleuropein, hydroxy tyrosol, verbascoside, apigenin-7-glucoside and luteolin-7-glucoside which has been reported as anti-SARS-CoV-2 metabolites in recent In silico, computational and in vitro studies. In addition, olive leaf extract was previously reported in several in vivo studies for its anti-inflammatory, analgesic, antipyretic, immunomodulatory and anti-thrombotic activities which is of a great benefit in the control of associated inflammatory cytokine storm and disseminated intravascular coagulation in COVID-19 patients. A placebo-controlled, randomized clinical trial at Fayoum University Hospital in Egypt will be conducted. RT-PCR confirmed COVID-19 adults showing mild to moderate disease will be enrolled in the study. Patients presenting with multi-organ failure, ventilator support, and chronic diseases (except diabetes mellitus and hypertension) were excluded. Patients were randomly assigned in 1:1 ratio to receive standardized olive leaves capsules (containing 20-50% oleuropein) or placebo up-to 10 days along with standard care. The expected outcomes included symptom alleviation, viral clearance, improvement of analysis (CBC, CRP, LDH, ESR, Ferritin, D-dimer, creatinine, ALT and AST) and a 10-day mortality in intention-to-treat population.
NCT05258734
Purpose: The aim of this study is to evaluate the effects of nursing interventions made with a mobile health application (COVOS) developed based on the Omaha System on the physical, psychosocial and cognitive symptoms and quality of life of patients diagnosed with COVID-19, and continuing treatment at home. Design: This is a single center, 1:1 randomized, single blind, parallel, active comparator trial. Method: Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) Statement 2013 checklist used in study. The CONSORT (Consolidated Standards of Reporting Trials) flowchart is used in this protocol. This study will carried out in a family health center, located within the boundaries of İzmit District of Kocaeli province. The patients in the experimental group will be followed up with the COVOS app and nursing interventions (videos, information messages) to manage their symptoms will be directed with the COVOS app. The patients in the control group will not receive any intervention, the standard follow-up and health care provided by the family health center of the patients will continue. Hypothesis: In patients diagnosed with COVID-19 followed at home with COVOS, symptom management and quality of life will be better in 1st, 2nd and 3rd months compared to the control group.
NCT05556707
Aim and objectives: To clarify the types, composition, distribution characteristics and risk factors of symptom clusters experienced by discharged patients with COVID-19, to lay the foundation for effective symptom management. Background: Even when patients recover from COVID-19 patients, the virus can still cause many long-term effects or complications.Therefore, it is crucial to assess the symptoms and influencing factors of discharged patients with COVID-19. Design: Cross-sectional survey. Methods:The investigators used the Post Discharge Experience Assessment Questionnaire for COVID-19 Patients and the Post Discharge Symptom Experience Risk Factor Questionnaire for COVID-19 Patients were used.Stratified random sampling was used to conduct a cross-sectional survey of 384 patients in recovery from COVID-19.Exploratory factor analysis was used to determine the cluster of symptoms, and a binary logistic regression analysis was used to identify the risk factors associated with this symptom cluster.
NCT04292665
Patients with heart failure will be entered. Participants will be randomized to one of three study arms: Arm 1: Classical massage, Arm 2: Relaxation, Arm 3: Control Hypothesis: Classical Massage and Benson Muscle Relaxation will decrease frequency, severity, discomfort of symptoms and improve quality of life.
NCT04892004
Describe a behaviour intervention to analyse self-care engagement in heart failure patients. Allocate patients with heart failure into 2 arms study: a control group and an intervention group.
NCT03968718
Listening to "patient voices" in terms of symptoms, emotional status, satisfaction with care and information received, represents a major shift in medicine. It is in fact crucial in medical decision making and patient empowerment, especially in cancer care. Patient Reported Outcomes Measures (PROMs) and in particular electronically assessed PROMS (ePROMS), have been identified as potentially effective tools to systematically gather patient voices. Despite international extensive and growing interest, systematic PROM collection is not widely implemented in routine cancer care, due to barriers at various levels. The PATIENT VOICES is a project aimed at achieving a stepwise inclusion and integration of PROMs within routine clinical practice at the FONDAZIONE IRCCS ISTITUTO NAZIONALE TUMORI-MILANO. Phase I of the Patient Voices project (pilot and feasibility testing), will be the focus of the present study and its results will be the base for subsequent phases (implementation and impact assessment).
NCT04843644
The investigators plan to conduct a 3-year pioneering care research project for mucositis in cancer patients. These include: (1) an analysis of the incidence and severity of mucositis, severity, treatment methods, and treatment costs; (2) an RCT comparing the effectiveness of honey, Taiwan green propolis, and usual care in mucositis of cancer patients; (3) monitoring of related symptom changes using a smart bracelet device; (4) a measurement of IL-1, IL-6, IL-10, and TNF, Microbiota in saliva, Microbiota in stool and (4) modeling of the trend of mucositis for alertness and search of essential parameters of the complications.
NCT04572282
With the growing number of cancer survivors, challenges to deal with comorbidities and impacted quality of life of cancer survivors by the disease and treatments also surge. Symptoms and Adverse Events are common and insufficiently monitored in real time / real life, which leads to increased symptom burden, treatment delays and unplanned hospital admissions. Remote monitoring apps have been shown to improve quality of life, symptom control and survival in published clinical trials, but no data with such interventions exists on the Portuguese population. We will conduct a pilot study to explore the feasibility of a mobile app for remote symptom monitoring in cancer patients. Patients will be recruited in Portuguese hospitals and will be invited to test the app for one month. Patient experience and satisfaction will be assessed via a weekly survey. The results of this pilot study will inform subsequent randomized clinical trials to test safety and efficacy of remote monitoring and lifestyle interventions to improve symptoms control and quality of life.