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

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.

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

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.

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.

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.

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.

Palliative Care Intervention to Improve Health Related Quality of Life for Patients on Long-Term LVAD Support

Background: While left ventricular assist device (LVAD) therapy improves survival in patients with advanced heart failure (AHF), unique LVAD-related burdens may impact health-related quality of life (HRQoL). Palliative care specialists are key members of the multidisciplinary care team for patients with long-term-LVAD (LT-LVAD), offering specialized, comprehensive, holistic care. Problem: A seminal study of palliative care in patients with heart failure (PAL-HF trial) demonstrated that outpatient palliative care improved HRQoL, depression, anxiety, and spiritual well-being compared to usual care. The impact of longitudinal palliative care on HRQoL in LT-LVAD patients is unknown. Objective: The investigators aim to conduct the first study examining a palliative care intervention to improve HRQoL among LT- LVAD recipients (patients who have lived with LT-LVAD for at least six months and are not heart transplant candidates) at two centers (MedStar Health and Inova) in the Mid-Atlantic Region. Given the demographics of the study institutions, the investigators anticipate a socioeconomically and racially diverse cohort of patients with subgroups who may disproportionately experience LVAD-related burdens relative to benefits. Aims: The first aim is to assess baseline measures of HRQoL in LT-LVAD patients to understand differences in HRQoL across subgroups and multiple, understudied domains. The second aim is to test the feasibility and acceptability of a randomized, unblinded pilot study of a palliative care interdisciplinary intervention in this population. Significance: Results of this study will inform the development of a large randomized controlled trial to test the effectiveness of palliative care intervention in improving HRQoL in LT-LVAD patients. If results are positive, this will revolutionize the post-LVAD treatment paradigm, by making palliative care integration the standard of care for longitudinal LT-LVAD patient management.

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.

Oral Health in Palliative Care: A Survey Study

Oral health problems such as xerostomia or oral infections are common in palliative care patients and can significantly impair quality of life. Adequate dental care may contribute substantially to symptom control and well-being; however, oral health and dental services are often insufficiently integrated into palliative care practice. In addition, little is known about the level of awareness, knowledge, and interprofessional collaboration regarding oral health among palliative care professionals. This prospective, non-interventional survey study aims to assess the relevance of oral health in palliative care by surveying both palliative care patients and healthcare professionals who are members of the German Society for Palliative Medicine. The study investigates patients' oral health status, oral health-related quality of life, and access to dental care, as well as professionals' knowledge, attitudes, and current practices related to oral health and dental care in palliative settings. The findings are intended to identify existing gaps and inform strategies for improved integration of dental expertise into palliative care.

Palliative Care and The Terminally Ill Adults (End of Life) Bill

The current study aims to investigate the potential impact of the proposed Assisted Dying (Terminally Ill Adults (2024) Bill on Palliative care workers. Palliative care professionals across the Humber Health Partnership will be interviewed using semi-structured interview questions, with the intention of exploring the way they make sense of the potential implementation of the bill, particularly in relation to their professional identity. The research will be carried out in line with guidance for Interpretative Phenomenological Analysis (Smith, Flowers \& Larkin, 2021), a research methodology which aims to explore how people make sense of their experience, often in response to a particular event. It is hoped that the study will contribute to the ongoing discussions regarding how the bill should be implemented and offer potential insights into ways that hospitals may best support staff during the passing of the bill into law. The study will be sponsored by Hull University Teaching Hospitals Trust (HUTH).

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.

Testosterone Supplementation in Patients in Best Supportive Care: Impact on Quality of Life

This is a monocentric, single-arm prospective pilot study that will enrol hypogonadal (testosterone \< 231 ng/dL) male subjects in best supportive care, with no further therapeutic options and no need for resuscitation. Currently, testosterone formulations for intramuscular (IM) injection and subcutaneous injection as well as for oral and transdermal administration have been approved for androgen therapy. To date, injectable testosterone is the most commonly used formulation. To increase serum testosterone levels to the physiological range IM injections of testosterone every 2-3 weeks are required, which lead to supraphysiological peaks shortly after administration, followed by a sharp fall in levels thereafter. Testosterone levels before the next injection are frequently in the hypogonadal range. For this reason, Sustanon 250® (1 ml, IM) will be administered on day 0 after confirmation of hypogonadism by blood test and then every 15 days in this trial given the limited life expectancy of the subjects and to maximise the effect and benefit of testosterone supplementation. The Edmonton questionnaire and ADL questionnaire will be completed before the injection on day 0 and then every 15 days at the time of injection until subject's death or if a subject is discontinued from the study treatment/procedures for any other reasons than death. In parallel, the EQ-5D-3L questionnaire will be completed by a family member or a proxy.

Attitudes Towards Deprescribing Medications in Cancer Patients and Impact of Educational Intervention by a Clinical Pharmacist

Participation in this study consists in responding to some questions from two questionnaires in Romanian about how participants feel about deprescribing, participants' treatment and how participants understand medical information. After that, participants will receive a brochure and watch a video with some basic information about medications and participants' involvement in treatment decisions and in the next visit for cancer treatment participants will be asked to answer questions from one of the initial questionnaire.

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.

A Study of Communication Between Clinicians, Patients, and Families in the Intensive Care Unit (ICU)

The purpose of this study is to investigate a specific approach to patient care called a time-limited trial (TLT). This approach is sometimes used for people who develop critical illness and are cared for in an intensive care unit (ICU). A time-limited trial is a plan made together by medical teams, patients with critical illness (if they can take part), and their families or other important people helping to make their healthcare decisions. A time-limited trial starts with a discussion of the patient's goals and wishes. Then, a plan is made to use ICU treatments for a set period of time to give the patient the chance to recover. After this time, the patient's response to treatment will be reviewed to help guide what to do next. Medical teams consider this kind of plan when it is not clear if a patient can recover to a quality of life that is acceptable to them. With a time-limited trial, patients, families, and medical teams experience this uncertainty together. The main goal of this study is to find the best way to use TLTs for patients in the ICU who have trouble breathing and need mechanical ventilation to help them breathe. The hypothesis is that optimal time-limited trial delivery will reduce the time patients with acute respiratory failure spend in the ICU and will improve the intensive care unit experiences for their families and clinicians.

Identification of Patients With Advanced Chronic Diseases in Need of Palliative Care

Patients with advanced chronic diseases often have complex health needs and may benefit from palliative care. However, many of these patients are not identified early enough to receive appropriate palliative care interventions. This prospective observational study aims to identify hospitalized patients and patients attending a day hospital with advanced chronic conditions who have palliative care needs, using the NECPAL tool. NECPAL is a validated screening instrument designed to identify patients with advanced chronic diseases who may benefit from palliative care, based on clinical indicators, disease progression, functional decline, and health care utilization. Adult patients with advanced oncological and non-oncological chronic diseases will be consecutively evaluated. The NECPAL tool will be applied by trained investigators as part of routine clinical assessment. Patients will be classified as NECPAL positive or NECPAL negative according to predefined criteria. The study will estimate the proportion of patients identified as NECPAL positive, describe their clinical characteristics, and analyze whether they are receiving palliative care. Secondary objectives include comparing clinical variables, comorbidity indices, and mortality between NECPAL-positive and NECPAL-negative patients over follow-up. The results of this study will provide information on the prevalence of palliative care needs among patients with advanced chronic diseases and support early identification strategies in hospital settings.

End-of-life Care in Mechanically Ventilated Patients: Impact of a Comprehensive Palliative Care Protocol in the Intensive Care Setting

The ARREVE-3 trial will evaluate whether a structured palliative care protocol can improve end-of-life management for mechanically ventilated ICU patients in whom a decision to withdraw life-sustaining therapies has been made. This cluster-randomized controlled trial compares protocol-based care with usual practice across participating centers. The intervention includes comprehensive guidance on symptom management, sedation, nursing care, withdrawal procedures, and family support, supported by standardized staff training. The primary endpoint is adherence to recommended end-of-life practices, while secondary outcomes assess patient comfort, communication with relatives, and the impact on families and healthcare professionals

A Feasibility Study of Death Education Intervention for Family Caregivers of Advanced Cancer Patients

Advanced cancer is the leading cause of death in the world and China. Family caregivers, as the closest individuals to advanced cancer patients, suffer from a range of psychological and spiritual issues due to patients' impending death. Various types of death education interventions have been developed to assist individuals in understanding the meaning of life and death and adapting to dying to address psychological and spiritual issues. However, these interventions have predominantly focused on advanced cancer patients only, with a significant gap in support for family caregivers. A mixed methods feasibility study will be conducted. A convenience sample of at least 30 family caregivers will be recruited. Participants will receive four 60-minute sessions, flexibly scheduled within a four-week period according to each participant's conditions. The researcher will be trained to deliver the intervention through individual face-to-face sessions in the oncology ward meeting room of the same hospital in phase I. The primary outcome will be feasibility (time to complete the recruitment, eligibility rate, recruitment rate, retention rate, attendance rate, acceptability rate). Secondary outcomes will be measured for preliminary intervention effectiveness on family caregivers' communication with patients on death, anxiety, depression, spiritual well-being, attitudes towards death, and quality of life after collecting the demographic information and written consent forms, and post-intervention. A descriptive qualitative evaluation will be conducted with 12 family caregivers to explore their experience of participating in the intervention by another researcher. The qualitative data in phase II will be audio-taped and transcribed verbatim and analysed using NVivo 14 through thematic analysis. The quantitative data will be entered in SPSS version 29.0. Descriptive statistics will be used to summarise the profiles of participants and outcomes.

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.

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.