Clinical Research Directory

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.

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

Integrating Rhythmical Massage in Palliative Care

People receiving palliative and end-of-life care may experience pain, fatigue, sleep difficulties, anxiety, and other symptoms that affect their comfort and quality of life. While standard medical treatments are important, additional supportive approaches may help promote comfort and wellbeing. Rhythmical Massage (RM) is a gentle, non-invasive touch-based approach involving rhythmic movements, light touch, warmth, and rest. However, there is limited evidence on its use in palliative care in Malaysia. This research will evaluate RM using quantitative measures of symptom burden, pain intensity, sleep quality, and physiological responses among people receiving palliative and end-of-life care in a community hospice. RM will be provided alongside, and will not replace, usual medical and palliative care. The findings will provide locally relevant evidence on the potential benefits, safety, experiences, and practical considerations of using RM as a complementary supportive approach in Malaysian palliative 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.

SPAMLO-3.0 : Having Fun Shedding Light on Darkness, a Playful Approach to Reduce Anxiety in Palliative Care

End-of-life care is often accompanied by anxiety-not only for patients in palliative care, but also for their loved ones and the healthcare professionals supporting them. This anxiety may stem from a fear of death, loss of functional abilities, or a worsening of symptoms as the illness progresses. It contributes to emotional, psychological, and physical suffering, ultimately diminishing patients' quality of life. Most data on palliative care focus on cancer patients, among whom anxiety prevalence varies greatly, but may affect more than 70% of individuals. Currently, anxiety in palliative care patients is managed through non-pharmacological approaches (such as environmental modifications and relaxation techniques) and/or pharmacological treatments (including antidepressants, neuroleptics, and anxiolytics). The investigators recently developed the serious game SPAMLO with the aim to present and raise awareness about palliative care. The educational scenario was built around three settings: the hospital, the home, and the nursing home (EHPAD). The participant will follow Vito, a virtual character, whose sister is receiving palliative care. Vito will explore the different types of support available, starting at the hospital. He will learn about what a collegial discussion is, the Clayes-Léonetti law, advance directives, the trusted person, as well as the specificities of pediatrics. Through home hospitalization, Vito will discover palliative care outside the hospital setting, including home adaptations with appropriate equipment and the various available support services. Finally, Vito will visit the nursing home, where topics such as oral care, respecting the patient's choices, and the importance of preserving them will be addressed. Thanks to its playful approach and the knowledge gained, this game could help reduce anxiety in palliative care patients through non-pharmacological means. This research project has beeen co-designed with a JALMALV volunteer (Accompany life until death - french association).

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.

Prehospital Care of End-of-Life Patients by the Strasbourg Mobile Emergency and Resuscitation Service: A Qualitative Study of Healthcare Professionals' Experiences and Use of a Comfort Care Booklet

Prehospital end-of-life care presents complex clinical, ethical, relational, and organizational challenges for healthcare professionals working in the Strasbourg Mobile Emergency and Resuscitation Service (SMUR). A comfort care booklet was introduced in the service in March 2025 to harmonize practices and improve the quality of palliative care delivered in the prehospital setting. However, professionals' experiences, perceptions of the booklet, its perceived impact on practice, and their needs have not yet been explored. This qualitative descriptive study will explore the experiences, perceptions, and needs of SMUR healthcare professionals regarding prehospital end-of-life care and the implementation of the comfort care booklet. Individual semi-structured face-to-face interviews will be conducted, audio-recorded, transcribed anonymously, and analyzed using an inductive thematic approach. Approximately 12 to 20 participants will be recruited through purposive sampling, with recruitment continuing until data saturation is reached.

Improvement of Quality of Life by Cannabinoids in Oncologic Patients

The goal is to explore whether the application of cannabis extract Avextra 10/10 solution is suitable to contribute to an improvement in the symptom burden and well-being of oncological palliative care patients. The primary objective of the study is to demonstrate the improvement in global symptom burden in the intervention arm compared to the placebo control group over a period of 12±2 days, as measured by a percentage change in the value of the Edmonton Symptom Assessment System total symptom distress score (ESAS TSDS) at baseline and after 12±2 days.

Pilot Study of MC in Paediatric Palliative Care

The goal of this pilot study is to explore the feasibility and acceptability of a medicinal cannabis clinical trial into easing the symptoms of children undergoing palliative care for non-oncological conditions. The trial will evaluate the study design including recruitment strategy, medication tolerability, duration and outcomes to determine acceptability and feasibility for participating families. The data collected will then be used to design a full-scale multi-centre trial. Participants will be randomly allocated to receive one of two medicinal cannabis products. Neither the participants nor researchers will know the study drug allocation until the end of the trial.

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.

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.

Effectiveness and Implementation of the DINKNESH Digital Palliative Care Tool in Ethiopia

The goal of this clinical trial is to learn if a digital health app called DINKNESH is effective for palliative care identification compared to traditional paper-based assessment tools. It will also look at the factors that help or hinder the use of this app in primary care settings. The main questions it aims to answer are: Does the DINKNESH app improve palliative care assessments compared to paper forms? What are the main barriers and facilitators for Health Extension Workers when using the app in their daily work? We will compare the DINKNESH app to standard paper-based tools to see if digital tools improve clinical assessment and implementation. Participants will: Be assessed for palliative care needs using either the DINKNESH mobile app or standard paper forms. Receive routine follow-up care as determined by their health provider. (For health workers): Participate in interviews or surveys to discuss their experience using the assigned assessment tool.

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.

Coaching in Palliative Surgical Oncology

This study aims to evaluate the effectiveness of a serious illness coaching intervention (CONCORD) in improving quality of serious illness conversation (SIC), treatment decision-making, goal-concordant care delivery and quality of life in patients with advanced cancer considered for palliative interventions. CONCORD will be delivered by lay healthcare providers. We compare outcomes between participants receiving CONCORD vs usual care.

The ProActive Study- Integrating a Proactive and Palliative Care Approach to Diabetic Ulcer Care

The ProActive study aims to investigate the feasibility of integrating a proactive palliative care approach into routine care for people with diabetic foot ulcers (DFU). The ProActive model includes procedures to identify patients who may benefit from a palliative approach and structured serious illness conversations (SIC) addressing patients' health situation, concerns, priorities, and preferences for care. Relatives may be involved when appropriate. The study examines the feasibility, acceptability, and appropriateness of the ProActive model and its implementation from the perspectives of patients, relatives, and healthcare professionals. It also evaluates the feasibility of outcome measures and data collection procedures for a future effectiveness study and examines the procedures used to identify patients who may benefit from the intervention. The feasibility study is conducted at two DFU clinics in Denmark and consists of four complementary sub-studies using qualitative and quantitative methods.