Clinical Research Directory

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

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.

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.

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 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.

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.

Virtual Reality Within Palliative Care (VR-SPC)

Literature so far shows VR is largely acceptable and feasible to use in palliative care settings, especially for improving patient wellbeing and mental health. However, limited research exists for understanding the effectiveness of VR, especially if sessions are repeated or offered jointly with patient carers or companions. We aim to investigate the effectiveness of VR for achieving personally meaningful goals (including but not limited to relaxation, bucket-list activities, and improving wellbeing). This study will be offered to patients and their companions receiving palliative care at a hospice in England. Informed consent will be acquired after a participant information sheet has been shared with interested participants. Personal goals of VR use will be established at the start of the study with baseline mental health and wellbeing data collection. Up to 3 VR sessions will be offered. Before and after each session patients will be asked to complete questionnaires to track wellbeing and progression towards intended goals for utilising VR. A change interview will occur between 1 to 4 weeks after the final VR session to discuss their overall experiences of VR and will include repeated follow up questionnaires. Participants that which to engage with a joint-VR intervention with their companion (referred to as participant companions for the purposes of this study), will also require informed consent and completion of questionnaires and interview attendance to be involved with this study. Results will be gathered and analysed by creating anonymous individual rich case records and shared with a panel of independent psychologists to conclude whether or not, from our findings, virtual reality is effective for achieving personally important goals. Findings will be shared with the hospice involved and form a Doctoral Thesis based at the University of Lincoln.

The Effect of Training Given to Nurses Caring for Patients Receiving Palliative Care on Pain Management Self-Efficacy

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.

Management of Dyspnea With High- Flow Nasal Therapy

Dyspnea in patients with incurable illness is a difficult symptom. Therefore, there is a need to identify new effective treatment modalities. Previous studies suggest that high-flow nasal therapy delivered via a nasal cannula (HFNT = High-Flow Nasal Therapy) may alleviate dyspnea, and similarly that directing airflow toward the face can provide relief. HFNT has been studied very little in hospice settings and on palliative care wards. The aim of this study is to determine whether HFNT is a feasible and effective treatment for relieving dyspnea in patients receiving palliative care. Patients will be recruited from the Hatanpää Palliative Care Ward and the Pirkanmaa Hospice, Tampere, Finland. The target is to recruit approximately 30-40 patients. The inclusion criteria are: age ≥18 years, ability to understand the study and provide informed consent to participate, a palliative treatment approach, and significant dyspnea. Each patient receives HFNT and fan therapy in which airflow will be directed toward the patient's face. Both treatments will last 30 minutes. Patient symptoms will be asked after the treatments. In addition, patients will be asked to rate the overall benefit they experienced from the intervention and any side effects. The primary endpoint is the relief of dyspnea with HFNT compared with fan therapy. The study will be conducted in accordance with laws, regulations, and guidelines governing medical research, as well as good scientific practice and research ethics. The study does not involve significant risks or measurements or sampling procedures that would cause additional discomfort. All other care for the patient will be provided according to the standard practices of the treating unit, and participation in the study will not limit any necessary treatments. Identifiable information will not be disclosed for use outside the research group. Results will be reported in a manner that does not allow patients to be identified. The Ethics Committee of the Wellbeing Services County of Pirkanmaa has approved the study. If successful, the study will significantly improve the care of the patients in palliative care.

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).

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.

Nurse-Led Caregiver Support Program in Home Palliative Care

This randomized controlled trial aims to evaluate the effect of a nurse-led caregiver support program on caregiver competency and healthcare utilization among family caregivers of patients receiving home palliative care. Family caregivers in the intervention group will receive a structured 6-week nurse-led support program including face-to-face education, weekly telephone coaching, caregiver guidance materials, and decision support for symptom management and healthcare utilization. The control group will continue to receive routine home palliative care services. Primary outcome is caregiver competency. Secondary outcomes include caregiver burden, self-efficacy, patient symptom burden, emergency department visits, and hospitalizations.

A Pragmatic Trial of an Active Choice Nudge for Generalist or Specialist Palliative Care for Seriously Ill Inpatients

This stepped-wedge, cluster-randomized pragmatic trial among six hospitals at University of Pennsylvania Health System will test a behavioral intervention embedded within the electronic health record that nudges hospital clinicians to either provide palliative care (PC) themselves (generalist PC) or consult specialists (specialty PC) for inpatients at high risk of death within 6 months. The trial will evaluate the intervention's effect compared to usual care on the primary outcome of hospital-free days through 6 months, and other patient-centered, clinical, and economic outcomes. The trial also includes an embedded mixed methods study to understand clinician and hospital contextual factors that influence the intervention's uptake.

Music Therapy for Cancer Patients(Meraki_PC)

The overall aim of the study is to analyse the impact of a music therapy-based treatment on the emotional well-being and quality of life of cancer patients in palliative care (PC). To this end, the effectiveness and efficiency of a music therapy-based treatment to improve adaptation to illness and psychological well-being in this population will be validated and implemented. Specifically, the implementation of an individualised treatment programme for palliative care patients will be carried out.

Palliative Care Needs Among Elderly People at Emergency Department

Aim: To assess what proportion of all patients over the age of 75 who seek care at the emergency department have palliative care needs and whether these are documented in the patient's medical record. Data collection and analysis: Patients over 75 years of age who seek care in an emergency department and are classified as triage 2-4 during initial triage are assessed by a researcher. Patients with dementia or other cognitive dysfunction will be excluded. Two types of data collection are included 1) Swedish Palliative care guide (S-PCG) documents that the researcher fills in together with the patient, 2) data from the patient's medical record, this data is collected according to a special assessment template. Data from the medical record will be collected after the patient left the emergency department. Data collection is ongoing until 300 patients have been included in the study. Data will be analyzed using descriptive statistics. Implications: The percentage of previously undetected/documented palliative care needs in emergency departments is relevant for prioritizing general palliative care within e.g. housing for the elderly and primary care S-PCG can be relevant to increase the level of knowledge at these care facilities. If it turns out that many patients have palliative care needs that are not met in the emergency department, health care structures need to ensure that these patients receive help at the right level of care. This would likely mean that the number of emergency visits and hospital admissions (with suffering and reduced quality of life as a result) can be reduced.

Problem-Solving Therapy for Cancer Caregivers in Outpatient Palliative Care

This study is a randomized clinical trial of a problem-solving therapy intervention for family caregivers of individuals with cancer receiving outpatient palliative care.

Effectiveness of the Mindful Compassion Care Program for Healthcare Professionals in Oncology and Palliative Care

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).

Lysergic Acid Diethylamide (LSD) in Palliative Care

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.

Latin America Network for Primary Palliative Care

Palliative care is the holistic care provided to individuals and their families who experience health related suffering related to life-limiting conditions. Palliative care is practiced by speciality level clinicians and also non-specialists. The term Primary Palliative Care (PPC) refers to the palliative care provided in primary care by primary care staff. In Latin America (LA), palliative care services have shown strong growth over the past two decades, but remain established and integrated in only a few localised areas across the region. Building on the success of the UoE's Global Access to Palliative Care Latin America (GAP - LA) Project led by the Usher Institute and funded by the UK Medical Research Council (grant number MR/V021400/1), primary care has been identified as a natural area for capacity building and strengthening to reduce health related suffering from serious illness and improve end of life care in Latin America. The researchers will collaborate with Pallium Latin America (PLA), a LA association involved in advocacy, education and clinical care in the region. The objectives of this study are: 1. To explore the facilitators and barriers to the implementation of a Latin American contextualised primary palliative care from the perspective of family medicine doctors 2. To list and describe the models in which palliative care is delivered within primary care 3. To define the process and outcome measures which would be meaningful for measurement of primary palliative care A Participatory Action Research (PAR) framework will be employed, combining both qualitative and quantitative components over 24 months. 30 to 50 primary care health professionals across LA will be recruited from the network already established by PLA to become co-researchers in line with the PAR methodology. 1. Online case-based discussion meetings (around 12 every 6 to 8 weeks) and post-meeting survey 2. Online individual semi-structured interviews (20-30) 3. Online co-researcher focus group discussions (3-5) 4. Co-researcher surveys 5. Documentary analysis Online meetings, interviews and focus group discussions will be recorded, translated and transcribed. Transcripts and surveys will be the data for analysis using NVivo, RedCap and MS Excell software.

SUPPORT+ Digital Self-Management and Clinical Support for Advanced Cancer

The goal of this clinical trial is to learn whether SUPPORT+, a digital symptom monitoring and self-management mobile application, can improve health-related quality of life and clinical outcomes in adults with advanced cancer receiving palliative care. The main questions this study aims to answer are: * Does use of SUPPORT+ help maintain or improve health-related quality of life compared with usual palliative care? * Does SUPPORT+ reduce functional decline and acute health care use, such as hospitalisations, compared with usual care? Researchers will compare patients using the SUPPORT+ mobile application with patients receiving usual palliative care to see if digital symptom monitoring combined with automated self-management guidance and nurse follow-up improves patient-reported and clinical outcomes. Participants assigned to the SUPPORT+ arm will: * Use the SUPPORT+ mobile application for weekly symptom reporting using the Integrated Palliative Care Outcome Scale (IPOS) * Receive automated self-management advice based on reported symptoms * Receive follow-up contact from a nurse when severe or concerning symptoms are identified * Continue to receive usual palliative care throughout the study period Participants assigned to the usual care arm will: * Receive usual palliative care provided by their clinical team * Complete study assessments at scheduled time points * Not receive digital symptom monitoring, automated self-management advice, or nurse follow-up through the SUPPORT+ application

Palliative and Supportive Care to Help People With Arthritis to Live Well (ENRICH)

Palliative Care (PC) focuses on maximising quality of life and care for patients and their families in the last 1000 days of life. Supportive Care (SC) is provided earlier in life for people with a long-term health condition. People living with inflammatory arthritis, (such as rheumatoid arthritis) can experience ongoing pain, stiffness, limitations in their joints, and intrusive fatigue. This impacts daily living activities and emotional well-being. People with inflammatory arthritis would value support to manage symptoms across the course of their disease. They would like PC healthcare professionals (HCPs) to understand their conditions better, so they can live well to the end of their lives. Aims: The investigators will explore the potential role of Palliative and Supportive Care (PSC) for people with inflammatory arthritis. The investigators will describe any unmet patient need. The investigators will develop clinical and research recommendations to help people with inflammatory arthritis live well over the course of their disease. Plan: The investigators research will be conducted in three studies: Study 1: The investigators will conduct 1:1 online interviews with people with inflammatory arthritis to understand how PSC is perceived by them, and what their views are on how PSC may support them to live well. Study 2: The investigators will send an online survey to Rheumatologists, Primary Care, Community and PC HCPs, to understand: * if and how they work together currently; * their views on the role of PSC supporting people with inflammatory arthritis to live well. Study 3: The investigators will conduct online focus groups with volunteers from Studies 1 and 2, representatives from relevant national charities/organisations, and people who commission health services. Together the group will discuss the research findings and agree: * what the gap in patient care is; * recommendations for future clinical practice and research; * the key areas of importance for patients which should be measured in future work

Complex Decisions Regarding Antithrombotic Therapy: the QUIET Study

"Complex decisions regarding antithrombotic therapy: the QUIET study" is a monocentric observational study without drug intervention, conducted through the administration of a questionnaire (survey).The aim of this study is to explore, through the administration of a questionnaire (survey) consisting of hypothetical clinical cases, the approach of physicians regarding the prescription, continuation, or discontinuation of antithrombotic therapies in patients referred to Palliative Care.

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

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.

MultidISciplinary Care paThway tailoRed on frAilty in Cancer Patients Referred to Outpatient paLliative Care

The goal of this clinical trial is to learn whether a structured, Patient-Reported Outcome Measures (PROMs)-tailored palliative care pathway improves clinical outcomes and care experience in adults with advanced cancer referred to outpatient palliative care. Patients with advanced cancer often experience multiple symptoms and complex needs. Standard outpatient palliative care is usually guided by clinical judgment on patient-reported questionnaires. In this study, researchers aim to test whether a more structured approach, based on predefined cut-offs from PROMs, can improve symptom control, satisfaction with care, and use of healthcare resources. The main questions the study aims to answer are: Does a structured, PROM-driven palliative care pathway reduce symptom burden and psychological distress compared with usual care? And through this, to improve patients' and caregivers' satisfaction with care or reduce emergency room visits, hospital admissions, healthcare costs, and aggressive treatments near the end of life? Researchers will compare two groups: Control group: Participants will receive standard outpatient palliative care. PROMs are collected as usual, but without predefined cut-offs or structured intervention checklists. Experimental group: Participants will receive a structured palliative care pathway tailored to symptoms/needs identified at baseline using PROM cut-offs. Specific multidisciplinary interventions are activated according to identified needs.