Als PhD student werk je mee aan de volgende 2 grote studies:
1. G-ONCOCOACH study
Title: The effectiveness of patient coaching within the comprehensive geriatric assessment (CGA) process on quality of life in older patients with cancer receiving systemic therapy: a multicenter randomized controlled trial.
Introduction. This study aims to evaluate the effectiveness of CGA coordinated by a geriatric team in combination with intensive patient coaching compared to the current standard of care, which is CGA coordinated by an oncology team.
Methods. A multicentre randomized controlled trial will be conducted in two academic hospitals with a follow-up at three, six and 12 months after the start of chemotherapy treatment. The randomization will be stratified for the score on the G8 screening tool, for the type of chemotherapy (monotherapy / polytherapy) and for stage (I, II, III, IV). Patients aged 70 years and older with a diagnosis of cancer (solid tumor) starting for the first time treatment with chemotherapy (all solid tumor types) will be included. Patients in the control group will receive CGA including geriatric recommendations for interventions based on GA results, which are communicated to the oncology team, but the performance of these recommendations will be left at the discretion of the oncology team. In the intervention group, patients will also receive a CGA, but the implementation of the recommendations will handled by the geriatric team in close collaboration with the oncology team, increasing the multidisciplinary care and an intensive patient coaching will be performed in order to increase patient compliance. This last intervention is added in order to support patient empowerment by improving self-efficacy and supporting self-management of existing geriatric problems. The patient coaching will include a counselling session at start of chemotherapy treatment to discuss the care plan with the patient and to determine their priorities, monthly counselling based on patient preference (eg. face to face, telephone) during the first 6 months after the start of the chemotherapy treatment, face-to-face counselling at 3, 6 and 12 months and an on-call service. Additional coaching is delivered when necessary. Patient focus groups will be actively involved in the development and conduct of the intervention in this trial. The primary endpoint will be QoL at 6 months (requiring 195 patients to be recruited); secondary endpoint are QoL at other time points (3 months, 1 year), functional status, chemotherapy-related toxicity, survival and patient satisfaction.
Current status. The study started accrual 10-2019, and already included 140 of the 195 patients needed by 1-2021. We expect to finalize accrual by May 2021. The primary endpoint (QoL at 6 months) will be evaluable by the end of 2021.
Role of the PhD student. The Phd student will be heavily involved in the data analysis and manuscript writing.
2. GERONTE STUDY
Title: Streamlined GERriatric and ONcological evaluation based on ICT (Information and Communication TEchnology) for holistic patient-oriented healthcare management for older multimorbid patients (GERONTE)
Introduction. Many older patients experience multimorbidity. They are managed through a disease-centered approach which is not appropriate, at least not for the most complex patients. Change to a patient-centered approach may simplify care pathways and decrease healthcare costs. It is expected to be a real breakthrough for daily practice with multiple impacts that must be quantified.
Methods. A large European consortium submitted a H2020 grant proposal that was awarded 10-2020 to organize a large prospective cluster-randomized trial in France, and another (similar) in Belgium/Netherlands evaluating the impact of patient-oriented healthcare management of older cancer patients. Prof Wildiers is the head responsible for the Belgian/Dutch study. The principal objectives of this randomized study are to evaluate the effectiveness of the GerOnTe ICT based health management pathway to improve patient quality of life at one year of follow-up.
The GERONTE multimorbid patient-centered system proposes: 1/ Coordination of management by a patient-tailored, interdisciplinary health professional consortium, including hospital- and home-based professionals, with a case manager; 2/ Timely registration of symptoms and patient-reported outcomes at home through a web-based app for anticipation of avoidable adverse events; 3/ Proposal of self-management guidelines according to intrinsic capacity evaluation by geriatrician for patient-driven improvement of independent living; 4/ Structured collection of data from electronic health record into a dashboard made available to health professional consortium members as well as patient and caregiver, thanks to its capacity to securely interoperate with all electronic health records including software managing medical data.
Study design is a stepped wedge cluster randomized controlled trial requiring 634 patients in 8 hospitals for the Belgian/Dutch study (and same numbers for the French study). Clusters will be participating hospitals, comprising eight investigating sites in total. This is a stepped wedge of cross-over type, i.e. patients are included continuously at predefined time points. Patients included at each "step" are different individuals. The first "step" is a reference measurement where none of the clusters has implemented the intervention. Then, investigating sites will be randomly drawn to determine the order in which they will implement the intervention, by "steps" of two months. The intervention will be prepared prior to the start of the trial, so that each investigating site can implement it within the time frame defined by the study schedule.
The whole approach will be co-designed with patients, informal care givers and health professionals. Cancer is an excellent model to develop this approach in multimorbid patients because it is frequent and commonly associated with other morbidities in older patients, but also because of its major impact on patients’ general status and coexistent diseases. The model may eventually be applicable in the whole multimorbid population (not only the cancer population).
Current status. This EU H2020 project, led by Pierre Soubeyran from France, received funding (6 Million euro) 11-2020 (H2020-SC1-BHC-2018-2020). The project consists of 8 work packages. Prof Wildiers is the head responsible for work package 4, which consists of a randomized clinical trial in Belgium and the Netherlands. The randomized trial will start accrual 10-2021, recruit during 18 months (till 4-2023), require 1y follow-up (till 4-2024), and likely lead to several high ranked publications in 2024-5. GERONTE will provide new country-specific guidelines and best practices for implementation across Europe and for improved management of older multimorbid patients focusing on improved quality of life and independent living at decreased costs.
Role of the PhD student. The PhD student will have 2 important tasks. First, the student will coordinate the set-up of this study in UZ Leuven and support the other Belgian/Dutch participating sites. Second, for the patients included in Leuven and randomized to the intervention arm (probably around 40 patients), the student will be the ‘case manager’ who coordinates the management in collaboration with a patient-tailored, interdisciplinary health professional consortium, including hospital- and home-based professionals.