Martina Sodano

Title : Investigation of unpleasant sensation perceptions amongst patients affected by Amyotrophic Lateral Sclerosis (ALS), during clinical trials procedures

Abstract:

Introduction: ALS diagnosis is considered a traumatic life event for both the patient and their next-of-kin/ carers, due to the lack of treatment for this degenerative disease. Clinical Trials can offer pioneering treatment to reduce the impact of the disease and improve future treatments worldwide. Research protocols for these treatments, may involve routine diagnostic and/or therapeutic procedures which the patients may be already aware of, and therefore expecting specific sensations. These could compromise participation or drop-out rate. Despite everything, participation in a clinical trial can guarantee continuity of care also thanks to the execution of these same procedures, through preferential access compared to other patients.
Aim: To investigate the perception of unpleasant sensations during procedures in clinical trials of ALS patients.
Methods: Descriptive phenomenological study and data will be analysed according to Sundler's method Expected Results: The identification of painful/unconformable procedures will help patients’ retention in ALS clinical trials and improve patients' experience and mental health, while increasing adherence and reducing dropouts. Furthermore, this could enhance adherence to the clinical trial pathway, through the reduction of anxiety states generated by annoying/painful procedures.
Conclusion: This study could holistically evaluate the quality of care and the taking charge of patient problems by the nurses and medical team. Implementing strategies, multidisciplinary care, and assistance.
This study could provide information for future studies to create an ALS Clinical Trials multiple-retention-factors adherence scale. Moreover, the study could help create and implement an ALS-specific pain scale accounting for its impact on daily activities, aiding an interdisciplinary approach of pain management.
 
Audience Take Away Notes:

- Analysing what type of pain/discomfort frightens patients during diagnostic and/or therapeutic procedures in ALS clinical trials
- To promote the development of soft skills and competences that help health professionals to assess both pain in ALS patients and the management of patient-centred pathways
- Formative cue to expand and share with other colleagues’ research or teaching in order to obtain more information and possible hints for future guidelines on the topic, such as in other medical disciplines/fields; furthermore it could be used as starting point to work on any specific pain assessment scales different pathologies.
- Provide data to implement effective therapy and offer constant patients support throughout ALS specific and needed procedures. Evaluate if this support could influence adherence rate of ALS patients to conduct clinical trials as required
- Identify the best pain management strategies and compliance techniques to address ALS, not merely in clinical trials. Provide the best individualised care for ALS patients improving their quality of life and mental state, as well as those of the caregivers

Biography:

Dr. Martina Sodano, already prior to her university studies and still currently, has always practised, promoted and organised voluntary work for people in economic-social-relational difficulties within her city of residence and in the hinterland. She graduated in April 2019 in Nursing from the University of Campania "Luigi Vanvitelli" with the vote of 110/110 cum laude. Subsequently, she worked in the emergency room and in the wards of the Bollate prison (Milan) and in the paediatric haematology and bone marrow transplant unit at the San Gerardo hospital (Monza). Furthermore, she obtained the role of authorised coordinator nurse at some polyclinics in Milan. Meanwhile, in November 2021 she obtained the First Level University Master's Degree in Coordination of Health Professions at the University of Milan-Bicocca while she introduced herself to clinical and nursing research at the European Institute of Oncology, IEO (Milan) . She therefore performed the role of clinical study nurse in a multi-specialist setting for observational studies and phase 1,2,3,4 clinical studies. Currently, she is the clinical study nurse, clinical study coordinator and data manager of the Neurological Clinical Trial Center (ALS / DEMENTIA / HEADACHE AND MIGRAINE) at the IRCCS Istituto Auxologico Italiano (Milan). She conducts research studies (both observational and interventional) following ICH GCP guidelines. Since 2022 she has been a member of the commission of INARC (International Network for ALS Research and Care). She carries out nursing research activities together with the team of research nurse colleagues and drafts medical-nursing study protocols with the multidisciplinary team of the trial centre. She has lectured to health and social care workers in global patient care activities and works as a thesis co-supervisor/tutor for undergraduate students.
She keeps up-to-date by following courses, congresses and conferences and follows continuous training in medicine (ECM); moreover, based on the organisational activities, she presents works of her own competence and workshops. She works in science and consciousness as a healthcare professional and, specifically, analysing and understanding evidence based nursing (EBN).