Clinical Research Directory

Nurse-Led Caregiver Support Program in Home Palliative Care

This randomized controlled trial evaluated a nurse-led caregiver support program for family caregivers of patients with cancer receiving home palliative care. A total of 162 caregivers were randomly assigned to the intervention or control group, with 81 caregivers in each group. The intervention included six weeks of structured education, weekly telephone coaching, caregiver guidance materials, and decision support for symptom management and healthcare use. As-needed telephone consultation remained available through week 18. Both groups received routine home care services. The primary outcome was caregiver competency. Secondary outcomes included caregiver burden, self-efficacy, patient palliative care concerns assessed using the Integrated Palliative care Outcome Scale, emergency department visits, and hospitalizations. Questionnaire assessments were conducted at baseline, week 6, and week 18.

The Effect of Pain Management Education Program on Pain Management Self-Efficacy Among Nurses Caring for Palliative Care Patients: A Quasi-Experimental Study

The goal of this quasi-experimental research designed as a single-group pre-test post-test model is to evaluate the effect of an educational intervention aimed at improving the pain management self-efficacy of nurses providing care to palliative patients on their pain management self-efficacy. The main question it aims to answer is "Does pain management training given to nurses caring for palliative patients improve pain management self-efficacy?". The study sample consisted of nurses providing care to palliative patients. Participants will receive training on "Pain Management in Palliative Care Patients" prepared by the researchers. The training will be given online via Zoom by Nurse Beste Aykaç Özbir, one of the researchers. The training will consist of 4 separate 50-minute sessions with 10-minute breaks, totaling 4 hours over one day.

Mobile Health Application for Family Caregivers in Home Palliative Care

Family caregivers play a central role in providing daily care for patients receiving home palliative care. However, caregiving responsibilities may lead to increased burden, stress, and difficulties in symptom management and care coordination. Mobile health (mHealth) interventions may provide accessible education, symptom monitoring, and decision-support resources to improve caregiver outcomes and patient care. The aim of this randomized controlled trial is to evaluate the effectiveness of a mobile health application developed for family caregivers of patients receiving home palliative care. The primary outcome is caregiver competence. Secondary outcomes include caregiver burden, self-efficacy, patient symptom burden, emergency department visits, and hospitalizations. A total of 120 family caregivers will be randomly assigned to either the intervention group, which will use the mobile health application for 6 weeks in addition to usual care, or the control group, which will receive usual care alone. Outcomes will be assessed at baseline, post-intervention (Week 6), and follow-up (Week 18).

Integration of Palliative Care in Pediatric Onco-hematology

PALONCOPED is a multicentre, interregional, observational and qualitative study aiming to better understand the early integration of palliative care in children with cancer. This study compares the practices, representations and temporalities of integration according to the type of cancer, in particular between hematological malignancies and solid tumors. The study seeks to identify the obstacles and levers encountered by professionals in pediatric onco-haematology and pediatric palliative care resource teams. It will be conducted in the hospitals of Nantes, Angers and Tours, based on about 45 semi-structured individual interviews with healthcare professionals. The data will be analyzed according to a reflexive thematic analysis, supplemented if relevant by a lexical analysis. The project aims to identify ways to improve for organizational and relational improvement, to strengthen collaboration between teams, and to promote earlier, coordinated care pathways adapted to children and their families.

Annual Wellness Visits vs GRACE-augmented Annual Wellness Visits For Older Adults With High Needs - Phase 2

This study consists of three aims focused on examining the feasibility of adding the Geriatric Resources and Assessment for the Care of Elders (GRACE) model to structured Annual Wellness Visits (AWVs) to improve patient and caregiver outcomes and reduce hospitalizations in older adults with complex health needs. The objectives are to: 1. Co-design a community-centric implementation strategy for the AWVs vs AWVs + GRACE -augmented care (AWV GRACE) study arms 2. Develop a referral pathway and algorithm to optimize enrollment of eligible participants 3. Conduct a pilot clinical trial to assess the feasibility of the AWV GRACE intervention.

Periganglionic Resiniferatoxin for the Treatment of Intractable Pain Due to Cancer-induced Bone Pain

Background: Cancer-induced bone pain (CIBP) is common in people with cancer. Bone cancer can also lead to anxiety, depression, and reduced mobility and quality of life. Researchers believe a research drug called resiniferatoxin (RTX) may be able to help. Objective: To learn whether RTX is safe and can reduce cancer induced bone pain. Eligibility: People ages 18 and older with CIBP that is not relieved by standard treatments Design: Participants will have up to 6 outpatient visits over about 7 months. These will include: Medical history Physical exam Blood and urine tests. Thermal testing: a disk placed on the skin to test ability to sense temperature in and around the area of pain Chest x-ray EKG: stickers are placed on the chest to measure heart signals ECG: measures electrical activity of the heart Participants will have 1 inpatient visit lasting 2-4 days. This will include: Catheter inserted into a vein in the arm. They are given anesthesia, sedation, and x-ray contrast. A needle is passed through the skin of the back to inject the RTX. Participants will keep a log of the pain medications they take after surgery. Participants will be called 1 week and 2, 3, and 4 months after the injection. Participants will be mailed surveys and questionnaires to complete 2, 3, and 4 months after the injection.

Effectiveness and Implementation of 'Supportive and Palliative Care Review Kit in Locations Everywhere'

Advanced cancer patients often experience significant physical and emotional symptoms, which can lead to frequent hospital visits and reduced quality of life. Although palliative care can help manage these symptoms and improve well-being, it is often introduced too late. A proactive symptom monitoring model, SPARKLE-2 aims to identify patients who need palliative care earlier by regularly checking their symptoms using a simple questionnaire. Patients with concerned symptoms will receive timely support from the palliative care team, with the goal of improving their quality of life, reducing unnecessary hospital admissions, and helping more patients receive care in the community rather than in hospital. In the earlier SPARKLE-1 study, it showed the improvement of patients' physical wellbeing. SPARKLE-2 seeks to test the effectiveness among advanced cancer patients with unplanned hospital visits while simultaneously collecting data on real-world implementation.

DEprescribing: Perceptions of PAtients Living With Advanced Cancer

Polymedication in palliative oncology care is a real public health problem. This phenomenon has been shown to increase the risk of iatrogenesis, reduce patients' quality of life and increase healthcare costs. For many years, health policies have been developed in geriatrics to reduce polymedication through deprescription tools. Recently, palliative care initiatives have been introduced, but without having studied the potential specificities of this population (younger, with a different care dynamic and life trajectory). It is important to better understand this population's perceptions of deprescribing in order to adapt tools/actions to make these approaches more efficient. The primary aim of this study is to investigate patients' perceptions of deprescribing in palliative cancer care, and the secondary aim is to investigate factors that may influence patients' attitudes and beliefs about deprescribing. At the same time, we will study the psychometric properties of the rPATD (Revised Patients' Attitudes Towards Deprescribing) in this population (a standardized questionnaire validated in geriatric medicine to assess patients' perceptions of deprescription).An ancillary study will be carried out to investigate the link between patients' health literacy and their perception of deprescribing (health literacy is defined as the ability to acquire, understand and use information in ways that promote and maintain good health). To meet our objectives, we will conduct a 3-year national, prospective, observational, multicenter study with an exploratory sequential mixed design. The study will comprise an initial qualitative phase. Semi-directed individual interviews using a descriptive approach will be carried out (around 25 patients, over an 8-month period). Following analysis of the qualitative data, we will then carry out a quantitative study to determine the distribution of the different profiles within this population and the factors influencing the perception of deprescription. The self-administered questionnaires, rPATD and BMQ (medication beliefs questionnaire), potentially supplemented by other items following analysis of the qualitative data, will be administered to 300 patients (over a 12-month period).The ancillary study will be carried out during this second phase, using a validated self-questionnaire to assess patients' level of literacy. Thanks to the different results, we will improve our knowledge of the perception of deprescription in palliative oncology care, in order to develop approaches adapted to the specificities of our population to reduce polymedication and thus improve the quality of life of our patients and reduce the risks of iatrogenia.

Music Therapy Program for Patients in Palliative Care (MUSPAL360)

Hospitalized patients with advanced cancer often experience a heavy burden of physical, emotional, and spiritual symptoms that affect their quality of life. This study will evaluate whether a structured, three-session music therapy program called MUSPAL360 can be feasibly delivered to hospitalized adult patients with advanced cancer receiving palliative care at Hospital Universitario Austral (HUA). MUSPAL360 includes three sessions delivered over about one week during hospitalization: Music therapy combined with virtual reality, focused on support and relaxation. Selection of personally meaningful songs, focused on communication and expression. Creation of a musical life story based on chronological biographical questions, focused on transformation. Family caregivers may participate in the sessions if the patient agrees. All participants receive standard palliative care in addition to the music therapy program; there is no control group and no randomization. This is a feasibility study, not a study designed to test whether the program works. The main goals are to determine the proportion of eligible patients, the proportion who consent to participate, how many complete each session, how complete the collected data are, and whether any adverse events occur. The study also collects preliminary, exploratory information on symptom burden and spiritual wellbeing before and after the program, to help plan the sample size of a future confirmatory study. The researchers plan to enroll a minimum of 40 hospitalized patients, anticipating substantial attrition between sessions due to the clinical course of advanced illness in this population.

Assessment of the Burden Within the Dyad Patient/Caregiver

This study is about the patients life ending and their caregiver, when a return to home is planned. This is a behavioral sciences study (= interventional study for french law)

Patient Journey in Palliative Care Within the NOVO Hospital Group.

This retrospective descriptive study aims to describe the sociodemographic, clinical, and organizational characteristics of patients identified as receiving palliative care who died in 2024 within the NOVO Hospital network. Data from medical records will include patient characteristics, involvement of general practitioners, use of palliative care services, healthcare utilization, and conditions of death. The study hypothesizes that improved characterization of these patients and their care trajectories will help identify opportunities for earlier palliative care referral and better coordination between hospital and community care.

Evaluation of the Effectiveness of Music Therapy on Anxiety Levels in Patients With Advanced Cancer Hospitalized in a Palliative Care Unit

A music therapy intervention can be either receptive or active. In both cases, somatic effects have been observed, with a direct impact on respiratory, cardiac and hemodynamic parameters, as well as psychological effects, creating a relationship of support, accompaniment and listening to the person. An intervention protocol using Kigonki has been developed and validated by the University Diploma in Music Therapy team at Paul-Valéry Montpellier 3 University (DUMM3). Studies on music therapy in palliative care have been published, but there is still a need for large controlled studies assessing the prolonged effect of a standardized intervention. This randomized clinical is designed for patients with terminal cancer pathology, hospitalized in palliative care units and with anxiety and depression scores both above 11 on the Hospital Anxiety and Depression scale (HAD). The primary endpoint is change in anxiety score. Patients included in the experimental arm will be offered the above-mentioned protocol with 3 weekly sessions of receptive music therapy with Kigonki for 2 weeks, after drawing up an intervention plan. Anxiety/depression levels will be measured before and 30 minutes after each session, as well as one week after the last session. Patients in the reference arm will have their anxiety/depression level monitored 3 times a week. In both arms, the study will be terminated at the end of the last protocol evaluation (i.e., at 3 weeks). If anxiety worsens (score rises by 2 points), a music therapy intervention similar to that performed for patients of the experimental arm may be proposed to patients of the reference arm. This project requires the participation of 84 patients, which seems feasible at the inter-regional level in 7 centers over 18 months.

Oral Care Interventions in PEG-Fed Palliative Care Patients

This pilot randomized controlled trial will compare three oral care interventions in adult palliative care patients who receive enteral nutrition through a percutaneous endoscopic gastrostomy (PEG) tube. The purpose of the study is to determine how these oral care interventions affect the health and integrity of the oral mucosa. Participants will be randomly assigned to one of three groups: oral care with Ankaferd Hemostat, benzydamine hydrochloride, or a combined solution containing methylprednisolone, ceftriaxone, and sodium bicarbonate. Oral care will be provided by trained nurses according to a standardized protocol. Participants' mouths will be assessed at the beginning of the study and on days 7 and 15. These assessments will include examination of the oral mucosa and standardized photographs of the mouth. Relevant clinical and laboratory information available as part of routine patient care will also be recorded. The findings will be used to compare changes in oral mucosal health among the three groups.

Resiniferatoxin to Treat Severe Pain Associated With Advanced Cancer

This study will examine the safety of giving the experimental drug, resiniferatoxin (RTX), to treat severe pain in patients with advanced cancer. RTX is a chemical extracted from a cactus-like plant. It is similar to capsaicin, the active ingredient in hot pepper. RTX has relieved pain and reduced the need for pain medication in several animal experiments. It works by destroying nerves that transmit pain information. People at least 18 years of age with severe pain from advanced cancer at or below the level of the chest that cannot be controlled with standard treatments may be eligible for this study. Participants undergo the following procedures: Pretreatment Visit Before beginning treatment with RTX, patients give a medical history and undergo a physical examination that includes: * Electrocardiogram (EKG) * Blood draw * Urinalysis * Neurological examinations * Peak expiratory flow rate (PEFR) * Eye examination * MRI * Urology assessment * Pregnancy test, when appropriate * Questionnaires to collect information on health, personality, mood, pain levels and symptoms. 2-Day Hospitalization Patients are hospitalized for 2 days for RTX injection and monitoring, as follows: * RTX injection: RTX is injected in the operating room under general anesthesia. It is given through a catheter placed in the patient s spine. The catheter is also used to obtain samples of cerebrospinal fluid (CSF) the clear fluid that bathes the spinal cord. The fluid is examined to assess drug effects and side effects, chemical changes in the content of the CSF associated with RTX, and how RTX is handled by the body. * Post-injection monitoring, including: * Surveys about symptoms such as pain or weakness * Neurological examinations * Blood and CSF sampling * EKG * AEs Outpatient followup * Vitals * Blood draw, Urinalysis, neurological and sensory testing, EKG on days 7, 14 and 30 after the injection * MRI scans of the head and back, Urology assessment and PEFR on day 15 after the injection * Eye examination * Follow-up phone calls monthly for 6 months

Coping Psychoeducation for Family Caregivers of Palliative Care Patients

This quasi-experimental study aims to evaluate the effectiveness of a six-week, nurse-led structured coping psychoeducation program for family caregivers of patients receiving palliative care. The study will examine the effects of the intervention on caregiver burden, coping strategies, and burnout using pre- and post-intervention assessments.

Primary Palliative Care - a Feasibility Cluster Trial

This feasibility cluster-controlled randomized trial (RCT) evaluates a complex intervention for the delivery of primary palliative care in Family Health Units (FHUs). The intervention consists of training General Practitioners (GPs) in palliative care through a 30 hour e-learning program and implementing a structured consultation model (4 consultations over 12 weeks) for adult patients with advanced chronic illness. One FHU will receive the intervention and one FHU will follow usual care. The primary goal is to assess feasibility metrics (GP adherence, patient recruitment rate, and patient retention rate), which will inform the design of a subsequent full-scale cluster RCT.

Yunzhi Essence to Improve the Quality of Life of Patients With Advanced Stage of Cancer

A randomized, double-blinded, placebo-controlled clinical trial using a Chinese Medicine 'Coriolus Versicolor for improving the quality of life of patients with advanced-stage cancer. Subjects will be randomized into a treatment group or placebo group for 6 months.

Improving Needs Among Older Adults

Millions of older adults receive care in intensive care units (ICUs) annually. However, the quality and accessibility of ICU-based palliative care is highly variable across hospitals and clinicians, due in part to specialists' limited workforce and geographic inconsistency. To address these gaps, the investigators developed an innovative mobile app-based primary palliative care intervention called ICUconnect. ICUconnect facilitates families' and patients' self-report of actual palliative care needs across all core domains of palliative care quality, provides ICU clinicians with a scalable digital infrastructure for coordinating consistent and personalized needs-targeted care, and provides a variety of informational supports relevant to each user's role. In this RCT, the investigators will test ICUconnect vs. usual care control among 350 patient-family member dyads with elevated baseline levels of unmet palliative care need in a 4-site network serving a diverse population (Duke, Medical University of South Carolina, University of Alabama at Birmingham, Columbia). The specific aims are to: (1) Test the efficacy of ICUconnect vs. usual care control in improving palliative care needs and other person-centered outcomes including psychological distress, (2) Determine participant characteristics associated with a greater treatment response using a heterogeneity of treatment effects approach, and (3) Ensure off-the-shelf intervention readiness for implementation using a mixed-methods integration of qualitative analysis of semi-structured trial participant interviews and quantitative RE-AIM implementation framework-informed trial data.

The Effect of PEG Use Education on the Care Burden and Quality of Life of Patients' Relatives

The study was planned to evaluate the effects of discharge training on PEG use given to palliative care patients' relatives on the caregiver burden and quality of life of the relatives. The main questions that the study aims to answer are as follows: * How does PEG training given before discharge affect the knowledge level of caregivers on PEG use? * How does PEG training given before discharge affect the caregiver burden? * How does PEG training given before discharge affect the caregiver's caregiver stress? * How does PEG training given before discharge affect the quality of life of the caregivers? The researchers will compare the PEG training given before discharge with a control group that did not receive training in this regard in order to evaluate the effects of PEG training given before discharge on the caregiver burden, caregiver stress and quality of life of the caregivers. The study will use a general information form, the Caregiver Burden Scale, the Caregiver Stress Index Form, the SF 36 Quality of Life Scale, and the Percutaneous Endoscopic Gastrostomy Tube Nutrition Information Scale for Caregivers. Participants: * Face-to-face interviews will be conducted with caregivers at 0, 1, and 3 months. * The forms used in the study will be filled out at each interview. * The intervention group will be trained only at the first interview.

Dysphagia Management for Caregivers of Stroke Patients

This randomized controlled experimental study was conducted to evaluate the effects of dysphagia management training provided to caregivers of stroke patients receiving home care. The sample size was determined using power analysis (n=84). Data were collected using the Personal Information Form, Mini Nutritional Assessment-Short Form (MNA-SF), Zarit Caregiver Burden Scale, Short Form-36 (SF-36) Quality of Life Questionnaire, and the Dysphagia Management Knowledge Form for Stroke Patients. Questionnaires were administered to both groups at baseline, the 1st month, and the 3rd month. The first application was administered to the intervention group before the education session.

Promoting Palliative Care for People With Heart Failure

This project will develop and test a novel clinical decision support tool (CDS) that encourages timely referral to palliative care for people hospitalized with heart failure. This intervention will incorporate an existing, validated 1-year mortality risk model into a CDS to deliver prognostic information and evidence-based decision support at the point of care. Thus, this research may lead to improved care-concordant and goal-directed care for people with heart failure.

Visual Art Therapy on Caregiver Burden

This study aims to determine the effect of Zentangle practice on perceived caregiver burden, stress levels, and burnout among family caregivers of patients receiving palliative care. Zentangle is a visual art therapy method used for meditative purposes by promoting creativity and focused attention in individuals under stress, which can facilitate mental relaxation, stress relief, and mindfulness. The study is designed as a randomized controlled experimental trial with a pretest-posttest design. The sample consists of 60 family caregivers of patients hospitalized in a palliative care unit, randomized into an intervention group (n=30) and a control group (n=30). Participants in the intervention group receive a two-week meditative art therapy intervention based on the Zentangle method, while data are collected through face-to-face interviews using validated psychological scales before and after the intervention period.

Patient Aid for Theory-Driven Health Communication (PATH): Translating Goal-Power Theory Into an Instrument and Generative AI Support for Palliative Care Communication

The goal of this clinical trial is to learn whether an artificial intelligence (AI)-supported communication tool can help improve communication between people receiving palliative care and their healthcare providers. The study will also evaluate a new questionnaire designed to measure the quality of healthcare communication. The main questions this study aims to answer are: 1. Can the new questionnaire accurately measure the quality of communication between participants and healthcare providers? 2. Does using the AI-supported communication tool, called NurseChat+, help participants feel more confident and prepared before meeting with their healthcare team? 3. Does NurseChat+ improve the quality of communication during palliative care visits? Researchers will compare participants who use NurseChat+ together with their usual care to participants who receive usual care alone to see whether the tool improves communication outcomes. The study will be conducted in three stages. First, researchers will develop and test a questionnaire that measures healthcare communication. Next, they will develop and refine the NurseChat+ tool. Finally, they will test the tool in adults receiving palliative care at National Taiwan University Hospital. Participants in the final stage of the study will be randomly assigned to one of two groups. One group will use NurseChat+ before their scheduled medical visits in addition to receiving usual care, while the other group will receive usual care only. Participants will complete questionnaires about their communication experiences during the study.

Bringing Life to Those Near Death

The purpose of this study is to assess whether virtual reality technology can reduce anxiety, depression, and emotional distress screening scores in palliative care patients.