Clinical Research Directory

Feasibility Study Incorporating Music Therapy to Optimise the Smoking Cessation Process Coordinated by a Tobacco Addiction Nurse in Smoking Patients Being Treated for Cancer

The innovative nature of this project lies in the combination of three types of intervention: tobacco addiction treatment, music therapy and therapeutic education. Three disciplines that work together. 1. Tobacco addiction treatment: reducing consumption, quitting, 2. Music therapy: acting on emotions and reward circuits, 3. Therapeutic education: promoting independent healthy practices. Patients learn to use the soundtrack independently to help them manage withdrawal symptoms caused by reducing or stopping tobacco consumption. In this programme, patients play an active role on several levels: * working with the music therapist to create a personalised 'soundtrack'; * identifying situations in which music can help them manage withdrawal symptoms; * using music independently in their everyday lives. The music therapy protocol will be proposed in this study, the soundtrack is co-created by the music therapist and the patient based on the patient's musical tastes and needs. The fact that the patient can use the musical tool independently also gives them significant leverage in their withdrawal process, allowing them to act on withdrawal symptoms and the main factors contributing to relapse.

Survivors Uniting for Remote Guided Exercise

The goal of this research study is to look at how live, online group exercise compares to recorded videos for helping increase physical activity levels, improve physical fitness and quality of life, and reduce loneliness among those living with and beyond cancer. The following aims have been established for this study: * Aim 1: Examine the effect of a group-based videoconference physical activity (PA) intervention on moderate to vigorous physical activity \[MVPA\] (i.e., aerobic and resistance exercise). * Aim 2: Examine the effect of the intervention on additional health-related outcomes including physical fitness (i.e., aerobic endurance, muscular strength), and quality of life at both timepoints. * Aim 3: Explore potential mediators and moderators of intervention effects. We will examine mediators (e.g., self-efficacy, outcome expectations, group cohesion) and moderators (e.g., age, cancer stage, neighborhood walkability) of the intervention on MVPA. * Exploratory Aim: Determine whether a group-based videoconference PA intervention reduces loneliness among cancer survivors. Researchers will randomize participants into one of two guided exercise groups that are 12-weeks long in duration. Participants will be asked to complete online fitness assessments and surveys as well as wear a physical activity monitor device and watch a few times throughout the study. The whole study is 9-months long in duration with a 6-month free-living period where no study activities will take place.

WellSpan-THRIVE Cancer QOL Study

Cancer affects millions of people worldwide and can significantly impact not only survival, but also day-to-day quality of life. Treatments such as surgery, chemotherapy, and radiation can cause side effects like fatigue, pain, and neuropathy, which may affect physical function, emotional well-being, and social relationships. While many studies have examined factors that influence quality of life; such as age, type and stage of cancer, and treatment-related symptoms; there is still a need for tools that more fully reflect patients' lived experiences. This study aims to develop and implement a patient-centered quality of life (QOL) survey designed specifically for individuals with cancer. By directly involving patients in sharing what matters most to them, the survey seeks to provide a more complete and accurate understanding of how cancer and its treatment affect daily life. The results will help patients, families, and healthcare providers better identify needs, guide supportive care, and improve overall well-being throughout the cancer journey.

Immune Adverse Events Registry in Onco-Hematologic Patients Treated With Immunotherapy

Immunotherapy is a therapeutic strategy aimed at inducing the immune system to identify and combat cancer cells and, alongside the evident clinical success observed in many patients, a specific toxicity profile has emerged, associated with the modulation of the immune system achieved with this type of drugs, known as Immune-Related Adverse Events (irAEs). irAEs encompass a highly heterogeneous spectrum of autoimmune manifestations that can potentially involve any organ or system, occurring in \~ 80% of patients treated with anti-CTLA-4 agents and in \~ 60-70% of patients treated with PD-1/PD-L1 inhibitors. However, severe (grade 3-4) irAEs affect only \~ 15% of patients treated with CTLA-4 inhibitors and \~ 5-10% of patients receiving anti-PD-1/PD-L1 agents, with a mortality rate ranging from 0.36% to 1.23%. The main characteristic of irAEs is their unpredictability in terms of time of onset, severity and responsiveness to immunosuppressive agents. Therefore, the management of irAEs often requires clever interpretation of clinical symptoms, proper choice of laboratory tests and imaging tools, and ability to perform differential diagnosis with other condition associated to tumour itself or to unrelated concomitant events (i.e., infections). Although international societies (i.e.; ESMO) have provided detailed guidelines for the management of irAEs or algorithms for the administration of ICI in patients with pre-existing autoimmune disease, they are sometimes difficult to be applied to certain complex situations. Furthermore, given the scarcity of data from clinical trials, some of these recommendations are mainly based on highly heterogeneous patients' population included in relatively small real world studies. Therefore, recommendations should always be adapted to specific clinical conditions and challenges. Studies investigating these aspects have particularly focused on the autoimmune antibody response, correlating its positivity in various ways with clinical outcomes. However, the results across different studies are not consistent. Moreover, additional prospective data are needed to confirm which information can guide the management of irAEs in order to optimize therapy and improve prognosis without negatively impacting oncological outcomes. The adoption of a therapeutic strategy tailored to irAEs is essential for improving both the immunological and oncological prognosis of patients affected by this group of manifestations. A prospective and cross-sectional observational approach to study irAEs is fundamental to the development of such therapeutic innovation. This study approach must be based not only on monitoring patients who have already developed irAEs but also on profiling patients even before the development of irAEs to determine which factors are associated with this group of pathologies and the different characteristics they may assume once they arise. The protocol will be based on the retrospective acquisition of data concerning the clinical history of the patients involved, from birth until recruitment into the study, and the prospective recording of information regarding the disease characteristics (both immuno-rheumatological and oncological) and the subsequent evolution of the clinical picture. Study procedures will take place during visits scheduled as part of routine clinical practice and will include the collection of data-clinical, laboratory, and imaging-related to the patient's oncological disease and irAEs, the characteristics of the diagnostic-therapeutic procedures performed, and the subsequent immuno-oncological outcomes. All patients scheduled to begin immunotherapy treatment will be enrolled in the study, as well as those who have developed irAEs without being enrolled prior to the onset of immuno-mediated manifestations. Enrolled patients who do not develop irAEs will be considered as the control group, providing essential information on risk profiling for the development of irAEs.

Hypnosis on Breathlessness Mastery in Patients With Persistent Dyspnea

Persistent dyspnea is a debilitating symptom, that is common and difficult to treat. This symptom is found in many different diseases including chronic obstructive pulmonary disease (COPD), interstitial lung disease (ILD), chronic heart failure (CHF), and metastatic cancer. Dyspnea is associated with many other symptoms, including anxiety, depression, and fatigue and is responsible for a significant reduction in quality of life. To date, only opiates are recommended for the pharmacological treatment of persistent dyspnea. The effectiveness of hypnosis is well known in the treatment of anxiety and delivered to patients suffering from chronic dyspnea for this reason. One randomised controlled study has shown that a single 20-minute mindfulness sessions could significantly reduce general symptom burden and have a significant impact on anxiety and depression in palliative care patients. Furthermore, the intervention had no negative side effects. Our aim is to evaluate the effectiveness of three hypnosis sessions on breathlessness mastery in patients with persistent dyspnea, using as a primary outcome the mastery domain of a validated tool, the Chronic Respiratory Questionnaire (CRQ).

Assessing Claims of Cannabis as an Anti-cancer Agent (CATA)

The purpose of the study is to find out how cannabis may help control cancer growth by reviewing medical records of patients who report cannabis helped treat their cancer.

Phase I Study of TSN084 in Patients With Advanced Malignant Tumors.

TSN084 is a novel type II protein kinase inhibitor with demonstrated anti-tumor effects in vitro and in vivo and targets multiple tyrosine kinases, such as c-MET, FLT3, TRK and serine/threonine kinase CDK8/19. This first-in-human study is conducted to assess the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT), to evaluate the pharmacokinetics, safety and preliminary anti-tumor activity of TSN084 in advanced or metastatic malignancies.