Clinical Research Directory

Home-Based Physiotherapy in Oncology

The goal of this clinical trial is to assess the feasibility, acceptability, and safety of a supervised home-based physiotherapy programme for adult oncology patients. The programme combines aerobic cycling exercise, resistance training, and mental preparation strategies, delivered at home with regular professional supervision. The main questions this study aims to answer are: Is a 6-month supervised home-based physiotherapy programme feasible in terms of recruitment, adherence, and retention? Is the programme safe for oncology patients undergoing or having recently completed cancer treatment? Is the programme acceptable and satisfactory from the patient's perspective? How do physical function and health-related quality of life change over the course of the programme? This is a single-arm feasibility study with no comparison group. Participants will: Receive a stationary exercise bike delivered and installed at their home Follow a 6-month individualized physiotherapy programme including: Three weekly sessions combining moderate-intensity cycling and resistance exercises Wear a connected activity watch during exercise sessions to monitor heart rate and exercise duration Receive weekly supervision from oncology-trained physiotherapists through alternating in-person hospital visits and structured phone calls Complete physical function assessments and questionnaires on quality of life, fatigue, and programme satisfaction at baseline, mid-program, and study completion The results of this study will inform the design of a future larger controlled trial and contribute to the development of accessible home-based rehabilitation programmes for oncology patients.

Implementation and Evaluation of a Program Aimed at Facilitating Palliative Care Conversations

Cancer is one of the leading causes of death worldwide. In the care of people with cancer, it is essential to pay sufficient attention to individual care needs and quality of life. One component of non-cancer-directed care, care aimed at addressing symptoms independent of the cancer or tumor, may be palliative care. Palliative care can be initiated at any point along the disease trajectory and can therefore be provided simultaneously with tumor-directed care. When initiated in a timely manner, palliative care can significantly improve the quality of life of both the person living with a life-threatening condition and their family. Pain management and attention to physical, psychosocial, and spiritual needs are central to this approach. Research shows that people with cancer develop palliative care needs well before the terminal phase. Communication about care needs, and palliative care in particular, is therefore essential for the timely initiation of palliative care. However, to date, palliative care is often initiated too late or not at all, frequently resulting in suboptimal care during the final months of life. Communication about palliative care is postponed or avoided by both healthcare professionals and people with cancer. Efforts are being made at various levels to make palliative care more discussable and to initiate it in a timely manner. At present, however, these efforts primarily focus on the role of healthcare services and professionals. By focusing solely on healthcare providers, palliative care has not yet been fully integrated as a standard component of oncological practice. The literature indicates that, in addition to barriers, there are also opportunities at the level of the person with cancer when it comes to initiating a conversation about palliative care with their physician, provided that adequate support is available. The health promotion approach, which focuses on the role of various personal and environmental factors in stimulating healthy behavior, is well suited to addressing this need for change in patient-initiated communication about palliative care. Health promotion makes use of theoretical behavioral models, for which evidence demonstrates that their application leads to more effective behavioral interventions and successful behavior change. These models have also been shown to be promising in promoting behaviors related to palliative care and in enhancing patient empowerment.

Muscle Deterioration in Hospitalized Cancer Patient

Cancer cachexia and skeletal muscle deterioration represent significant challenges in oncology, affecting up to 42% of cancer patients and correlating with poor clinical outcomes, increased treatment toxicity, and reduced overall survival. Early identification of patients at risk through comprehensive musculoskeletal assessment is essential for timely therapeutic intervention. This paper presents a detailed protocol for the longitudinal evaluation of skeletal muscle deterioration in hospitalized cancer patients using an integrated, multimodal approach. The protocol combines validated questionnaires (SARC-F, MSAS, EORTC QLQ-C30, and PSQI), functional measurements (handgrip strength), body composition analysis (bioelectrical impedance analysis), neuromuscular assessment (surface electromyography), and serum biomarkers (basic panel approach). The study aims to recruit 45-50 patients with confirmed malignancy requiring hospitalization for ≥4 days, with daily functional measurements and biomarker evaluations at admission and discharge. The protocol prioritizes methodological rigor in vulnerable populations, incorporates standardized procedures for real-world clinical settings, and emphasizes quality control measures. Expected outcomes include the identification of longitudinal patterns of muscle deterioration, validation of serum biomarker signatures for cachexia detection, and characterization of neuromuscular fatigue patterns using surface electromyography. This comprehensive framework addresses current gaps in skeletal muscle assessment during acute hospitalization and provides a foundation for future interventional studies. The protocol adheres to international ethical standards and considerations for research in vulnerable populations.

Study Protocol: Impact of Metamizole (Optalgin®) on Anti-Xa Concentrations in Oncology Patients Receiving DOACs

Evaluation of the Effect of metamizole (Optalgin®) on Anti-Xa Levels in Oncology Patients Receiving Direct Oral Anticoagulants (DOACs)

Analysis of the Determinants of the Participation of Patients and Health Professionals of the University Hospital Center of Martinique in Clinical Research Protocols in Medical Oncology (StudyOrec)

For optimal patient care, it is imperative that healthcare professionals implement appropriate strategies. These strategies must take into account changes in healthcare practices associated with advances in medications and medical equipment. Clinical trials play a crucial role in validating the efficacy and safety of these advances, ensuring high-quality and constantly improving healthcare. However the proportion of patients included in therapeutic trials is often considered too low. Several ideas have been explored to explain the low participation rate in research projects. These are closely linked to research actors and tools, such as, for example: * the research protocol and its eligibility criteria, which may be overly strict * healthcare professionals with the barriers encountered in carrying out research programs (motivation, attitude and perceptions, human, logistical and technical constraints, lack of training) * patients who are generally poorly acculturated to clinical research, the lack of information for patients in healthcare services, and patients' lack of trust in the healthcare system. * ... In Martinique, healthcare professionals face the same challenges in including patients in clinical trials. Patient inclusion is necessary due to the region's demographic and medical characteristics. To improve patient inclusion in these trials, it is important to define the human and material barriers and levers that influence the participation of patients and healthcare professionals in clinical research protocols in the medical oncology departments of the Martinique University Hospital. The investigators believe that increased patient awareness of the benefits of clinical research, equally increased incentives for healthcare professionals, and the establishment of adequate support structures would increase participation in clinical research protocols within the medical oncology departments of the Martinique University Hospital. By conducting a mixed qualitative and quantitative study to gather the perspectives of patients and caregivers, the investigators aim to identify the human and material barriers that limit the participation of oncology patients in Martinique.

Financial Toxicity (FT) for Radiotherapy (RT) Patients in Italy: a yAIRO (Associazione Italiana Radioterapia e Ocologia Clinica) Multicenter Study

Non- profit, multicenter, prospective, observational study. The study aims to assess financial toxicity (FT) in patients undergoing radiotherapy for oncological diseases, assessed with a validated questionnaire (Patient Reported Outcome for Fighting FInancial Toxicity-PROFFIT- questionnaire).

Implications of Biological and Procedural Factors of 18-f FDG Uptake by Normal Organs and Neoplastic Lesions

To evaluate implications of biological and procedural factors of 18-f FDG PET/CT uptake on normal organs and neoplastic lesions.