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Palliative Care clinical trials

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NCT ID: NCT04900103 Recruiting - Palliative Care Clinical Trials

Evaluation of Implementation of ITV-Pal Program

ITV-Pal
Start date: November 1, 2021
Phase: N/A
Study type: Interventional

How can offer support to patients and families through a volunteer caring program based on new technologies? The aim of this study is to implement and evaluate a volunteer training programme in the use of new technologies: ITV-Pal Programme to support patients facing a life-threatening illness and their families. It will created two groups of volunteers, one group will follow the CUDECA standard training program, the other will follow the proposed intervention, ITV-Pal programme. Volunteers will be allocated randomly to each group. Second stage will consist in the implementation of the direct support to patients and families through the volunteers. The expectation is that ITV-Pal volunteers trained will be able to increase general welfare of patients and families they care for. To test it, the quality of life of patients, families and volunteers, the quality of the dying process, and identify how new technology supports volunteer end of life care will be measure.

NCT ID: NCT04708002 Recruiting - Palliative Care Clinical Trials

Interventional Research With Mixed Methods on an Early Integrated Palliative Approach in Nursing Home

Start date: March 30, 2021
Phase: N/A
Study type: Interventional

The national context of the end of life of elderly people living in Nursing Home (NH) is concerning. A quarter of NH residents die each year representing a quarter of annual deaths in France of all ages. The number of resident deaths arises (148,300 deaths in 2015 versus 124,500 in 2011). In fact, the age of residents welcomed in NH increase, 82% of residents are 80 years old and over, suffering from several chronic pathologies, some of which are serious and incurable. These are the main cause of death for residents. The advancing age of NH residents and the interweaving of multiple chronic conditions and disabling pathologies generate complex care needs, the complexity of which undermines the current system of care organization. In 2016, 59% of NH residents were severely dependent in their activities of daily living (ADL) and instrumental activities of daily living (IADL) according to the French scale Autonomie, Gérontologie Groupe Iso Ressources, (1 the most dependant to 6 the less dependent); the majority of these most dependent NH residents (80% of Groupe Iso-Ressource 1-2 in 2011) had at least one unstable chronic pathology and 73% of deceased residents (in 2015) come from this group whose level of dependence is very high. Palliative care (PC), which is care focused on maintaining quality of life in a context of incurable and complex pathology, therefore appears to be indicated in the context of NH. However, residents' access to PC remains limited, uneven and late. The number of residents requiring this support is estimated at more than 100,000 residents per year. The consequences of such situation are serious, first with regard to the quality of life of NH residents and their family caregivers, but also the inappropriate use of health services (as shown by the excessive use of emergency department and unscheduled hospitalizations) and work life for care providers in NH is affected (care providers suffer from a lack of support when faced with the difficulties of caring for NH residents at the end of their life). However, these consequences are potentially avoidable by means of adapted organizational solutions. The implementation of an integrated and early palliative approach (IEPA) in care pathway of patient is one of the solutions recommended by the World Health Organization and the French National Authority for Health. Several studies have shown the benefit of such approach in the management of cancer patients. However, the transferability and effectiveness of this approach in other organizational and population contexts are poorly documented, particularly in NH settings. The main objective is to evaluate, through a pragmatic controlled trial the effectiveness of an Early Integrated Palliative Care Approach in usual NH context (EIPCA-NH) on the quality of care in NH for elderly in need of PC. The secondary objectives concern: 1. the implementation process of the EIPCA-NH: i) measure the degree of implementation of the EIPCA-NH in each site, ii) identify and understand the factors (individual and organizational) facilitating or limiting the success of the implementation process of an IEPA according to NH contexts (inter-site comparison). 2. the effects of the EIPCA-NH in the NH : i) on the quality of life of residents requiring PC and ii) that of their family caregivers, iii) on the quality work life of professional caregivers and iv) on the care pathway of NH residents. A mixed methods research, with qualitative and quantitative approach, will be carried out in at least 20 NH in three different health territories. These NH will benefit from a EIPCA-NH intervention which consists of 1) implementing a mechanism for sharing and co-producing knowledge, 2) integrating this approach as early as possible in the care of residents. This study is based on a multicenter, randomized crossover cluster-type stepped-wedge study, running on 4 years in order to measure the sustainability of EIPCA-NH; the quantitative analysis of the effectiveness of EIPCA-NH will focus on an open cohort of 3,500 residents receiving the intervention. The qualitative component will consist of a multiple case study to analyse the process of implementation and production of the EIPCA-NH. The integrative analysis of qualitative and quantitative data will allow a better understanding of the causal mechanisms of the observed phenomena. This project will provide evidence on the value of EIPCA and the conditions for its implementation and transferability. The proposed intervention will help improve care practices for all NH residents (600,000 people). The approach by co-construction between actors of the thousands of care structures (NH, cities, hospitals) and researchers should promote a better representation of PC, promote the culture of anticipation, evaluation and collaboration between actors of in- and out- NH, contributing to a better synergy of intersectoral and territorial actions of the supply of health services.

NCT ID: NCT04664270 Recruiting - Depression Clinical Trials

Developing and Implementing E-psychotherapy Program for Mental Health Challenges in Oncology and Palliative Care

Start date: March 1, 2021
Phase: N/A
Study type: Interventional

The demand for mental health problems, particularly depression and anxiety, is three times greater in Oncology and Palliative Care Centres than in the general population. There are unique factors in this population that make them more susceptible to mental health challenges. The disease itself, the adjustment to a chronic/fatal diagnosis, and the treatment options can all perpetuate the development of mental illness. Despite the well-established association, there have been barriers to access suitable treatment for these patients. Online Psychotherapy is an effective treatment option that may address many of these barriers. This modality has been proven effective in addressing depression and anxiety in other populations. To date, there has been no psychotherapy module developed specifically for oncology and palliative care patients to our knowledge. The aim is to establish the first academic e-psychotherapy treatment option to address mood and anxiety disorders in oncology and palliative care patients. The investigators will use the Online Psychotherapy Tool (OPTT), a secure cloud-based platform for online delivery of e-CBT, developed by the PI. The proposed study aims to establish the feasibility and effectiveness of delivering online psychotherapy to oncology and palliative care patients who have a comorbid depressive or anxiety disorder. The patients will be enrolled in an 8-week program with a combination of cognitive behavioural therapy (CBT) and Mindfulness techniques delivered via a series of modules. They will receive individualized feedback from a trained therapist weekly. It is hypothesized that delivering this psychotherapeutic intervention in this manner will have great adherence. The aim is to prove that it will improve the quality of life and decrease symptoms of depression and anxiety in this underserved patient population.

NCT ID: NCT04527692 Recruiting - Palliative Care Clinical Trials

Quality of Life of Children/Adolescents in Palliative Care Settings

MOSAIK
Start date: April 15, 2020
Phase:
Study type: Observational

Investigators will propose to each family monitored by the teams to participate in the study (children between 1 and 18 years old, families understanding and speaking a minimum of French). Semi-directed interviews are organized with children/adolescents and their parents who have agreed to participate in the study. The interviews are conducted by the care teams themselves. Socio-demographic data are collected.

NCT ID: NCT04347629 Recruiting - Palliative Care Clinical Trials

Improving Medical Decision Making for Older Patients With End Stage Renal Disease

VIDEO-KD
Start date: June 21, 2021
Phase: N/A
Study type: Interventional

The overall objective of this study is to reduce the burden of chronic kidney disease (CKD) and its consequences for an aging U.S. population. To accomplish this, the investigators propose to conduct a multi-center randomized trial of an advance care planning (ACP) video intervention (vs. usual care) among older patients with CKD.

NCT ID: NCT04052074 Recruiting - Palliative Care Clinical Trials

Complementary Therapy in Home Palliative Care Patients and Their Caregivers

COMTHECARE
Start date: September 20, 2019
Phase: N/A
Study type: Interventional

Introduction: There is an increase on cancer prevalence and, consequently, a higher number of people that require palliative care, making an influence on the family and the main carer. Objectives: - To evaluate the efficiency and cost-effectiveness of a music intervention program, applied as a complementary therapy, in oncological palliative care patients and carers at home, compared to current treatment. - To assess if patients in the intervention group submit significant differences regarding: pain, anxiety, depression, modo, insomnia, and life quality. - To assess if carers in the intervention group present significant differences regarding the Caregiver Burden Scale and life quality. - To evaluate patients and carers satisfaction on the therapeutic intervention. - To estimate the cost-effectiveness of the intervention. Method: Randomised, double-blind, multi-centre clinical trial in the field of primary health care, conducted in 5 clinical management units belonging to Málaga-Guadalhorce health district and performed in oncological palliative care patients and carers. Two samples of 40 palliative care patients and two samples of 41 carers. The intervention group will undergo a 7-days intervention with music sessions, the control group will be given seven sessions of retraining in therapeutical education. Objectives will be evaluated through the following tools: Edmonton Scale, Symptom Assessment System, EORTC QLQ-C30, Caregiver Burden Scale, Pittsburgh Sleep Quality Index, Accelerometer, Epworth Sleepiness Scale (ESS), The Quality of Life Family Version, Client Satisfaction Questionnaire and Economical valuation. To assess the objectives evaluations will be performed through home visit, both pre-intervention and a week after the beginning of the intervention for both groups. A follow-up visit will be made a month after the intervention to regard some economical parameters. Statistical analysis: The basal values of both groups will be compared. These values will be compared before and after the intervention, in the control and intervention group through Student t-test for normal continuous variables, and through Wilcoxon t-test for paired data in not normal continuous variables. In addition to the bivariated analysis, a multiple lineal regression will be carried out. The economical valuation will be a cost-effectiveness analysis. For each group we will measure cost, incremental cost, AVAC effectiveness, incremental effectiveness, dominance and, in case there is none, the results will be expressed in terms of incremental cost-effectiveness. To assess the costs, direct sanitary costs and intervention related costs will be considered. SPSS 23 will be the statistical software to use, along with Epidat 3.01. 95% confidence range will make p values under 0,05 (p<0.05) statistically significant.

NCT ID: NCT03944044 Recruiting - Palliative Care Clinical Trials

Paracetamol Route in Palliative Care Patients (PARASCIVPALLIA)

PARASCIVPALL
Start date: July 15, 2019
Phase: N/A
Study type: Interventional

Background: Among palliative-care patients, subcutaneous route is often an alternative to intravenous route yet pharmacological and clinical data are lacking. Many French palliative crew are now using empirically paracetamol by subcutaneous route also there is no data to support this practice. The aim of the present study is to compare pharmacokinetics parameters between intravenous and subcutaneous route for palliative-care patients. Methods/design: A randomized, open, crossover, bicenter study in two palliative care centers. The aim is to demonstrate the pharmacokinetic equivalence between the two routes of administration. Data analysis will be performed by Wilcoxn's signed Rank Test with an alpha risk of 5 percent. All adverse events will be reported for a safety analysis. Discussion: This trial may permit, if a pharmacokinetic equivalence is established, to build randomized controlled trials to then assess the efficacy and tolerability of subcutaneous paracetamol administration.

NCT ID: NCT03804333 Recruiting - Palliative Care Clinical Trials

Short Course Radiation Therapy in Palliative Treatment of Pelvic Cancer

Start date: November 8, 2017
Phase: N/A
Study type: Interventional

Aim of the study is to assess efficacy of a short course radiation treatment in patients with symptomatic pelvic malignant lesions

NCT ID: NCT03804307 Recruiting - Palliative Care Clinical Trials

Short Course Radiation Therapy in Palliative Treatment of Thoracic Cancer

Start date: November 8, 2017
Phase: N/A
Study type: Interventional

Aim of the study is to assess efficacy of a short course radiation treatment in patients with symptomatic thoracic malignant lesions

NCT ID: NCT03804203 Recruiting - Esophageal Cancer Clinical Trials

Short Course Radiation Therapy in Palliative Treatment of Esophageal Cancer

Start date: November 8, 2017
Phase: N/A
Study type: Interventional

Aim of the study is to assess efficacy of a short course radiation treatment in patients with symptomatic esophageal malignant lesions