The GerOnTe TWOBE study aims to evaluate the effectiveness of the GerOnTe intervention, consisting of a renewed, patient-centred, care pathway coordinated by an APN and supported by a Health Professional Consortium and IC Technology, compared to the current standard of care in the eight different Belgian and Dutch hospitals.
The GerOnTe TWOBE study aims to evaluate the effectiveness of the GerOnTe intervention, consisting of a renewed, patient-centred, care pathway coordinated by an APN and supported by a Health Professional Consortium and IC Technology, compared to the current standard of care in the eight different Belgian and Dutch hospitals. The GerOnTe project consists of two identical trials in two different European geographical areas, FRONE in France and TWOBE in Belgium and the Netherlands. The goal of two identical trials is to take into account the role of health care contexts in the implementation, effectiveness and efficiency of the GerOnTe intervention. A stepped wedge randomized controlled trial, where the randomized clusters will be participating hospitals, will be conducted in eight academic and general hospitals in total with a follow-up at 3, 6, 9 and 12 months after study inclusion. Patients will be recruited in all participating hospitals in the period between the cancer diagnosis and the treatment decision.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
In the intervention group, the renewed, patient-centred care pathway will be coordinated by the Advanced Practice Nurse (APN) and will be supported by digital technology. The intervention aims to increase the involvement of the patient in the treatment decision process, to provide comprehensive care through the quarterly meeting of all professionals involved in the care of the patient during a Health Professional Consortium (HPC) and to support patient empowerment by supporting self-management by using digital tools.
In the intervention group, the renewed, patient-centred care pathway will be coordinated by the Advanced Practice Nurse (APN) and will be supported by digital technology. The intervention aims to increase the involvement of the patient in the treatment decision process, to provide comprehensive care through the quarterly meeting of all professionals involved in the care of the patient during a Health Professional Consortium (HPC) and to support patient empowerment by supporting self-management by using digital tools.
UZ Gasthuisberg Leuven
Leuven, Belgium
Quality of Life (QoL): EORTC QLQ-C30
Quality of Life assessed by the EORTC QLQ-C30 (version 3.0) questionnaire. HRQOL evaluation was performed using the European Organization for Research and Treatment Quality of Life Questionnaire core 30 (EORTC QLQ-C30) Global Health Status Scale (GHS). Three derived scores of the QLQ-C30 questionnaire are considered as primary endpoints: * Normalized global health status score of the QLQ-C30 (version 3.0) (score 0-100), * Normalized score of the physical functioning scale of the QLQ-C30 (version 3.0) (score 0-100), * Normalized score of the emotional functioning scale of the QLQ-C30 (version 3.0) (score 0-100). A high score for a functional scale represents a high / healthy level of functioning. A high score for the global health status / QoL represents a high QoL.
Time frame: QoL at 6 months after study inclusion
Quality of Life (QoL): EORTC QLQ-C30
HRQOL evaluation was performed using EORTC QLQ-C30 Global Health Status Scale (GHS) and Quality of Life Questionnaire Elderly Cander Patients 14 (EORTC QLQ-ELD14) Global Health Status Scale (GHS). * Normalized scores of global health status, physical functioning scale and emotional functioning scale of the QLQ-C30 (version 3.0) (score 0-100). * Normalized scores of the QLQ-C30 symptom scales/items (score 0-100). * Scores of QLQ-ELD14 scales/items (score 0-100). A high score for the global health status / QoL in QLQ-C30 represents a high QoL. A high score for a symptom scale / item represents a high level of symptomatology / problems. High scores in QLQ-ELD14 indicate poor mobility, good family support, much worry about the future, good maintenance of autonomy and purpose, and high burden of illness.
Time frame: QoL at 3, 9 and 12 months after study inclusion
Overall survival
Survival as the length of time from the start of treatment and death from any cause.
Time frame: at 12 months after study inclusion
Progression-free survival
Progression-free survival (PFS) defined as the time from study treatment initiation to the first occurrence of disease progression or death (of any cause), whichever occurs first.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: at 12 months after study inclusion
Patient autonomy (1)
Dependence score measured by Activities of Daily Living (ADL). The ADL scale includes six items (bathing, dressing, toileting, transferring, continence and feeding), with a score for each item scores ranging from one (able to perform the activity) to four (unable to perform the activity) (range: 6-24).
Time frame: At baseline, 3, 6, 9 and 12 months after study inclusion
Patient autonomy (2)
Proportion of patients living at home (range: 0-100%). The higher the percentage, the more patients live at home.
Time frame: At 6 and 12 months after study inclusion
Patient autonomy (3)
Number of completed chair stands in 30 seconds measured by the Chair Stand Test. Participants stand up repeatedly from a chair for 30 seconds.
Time frame: At baseline, 3, 6, 9 and 12 months after study inclusion
Patient autonomy (4)
The overall level of fitness or frailty of the older patients will be assessed by the 9-point Clinical Frailty Scale (CFS) (score: 1-9). The higher the score, the less fit or more frail the older person is.
Time frame: At baseline, 3, 6, 9 and 12 months after study inclusion
Patient autonomy (5)
The ECOG Performance Status Scale (ECOG-PS) describes a patient's level of functioning in terms of their ability to care for themself, daily and physical ability (score: 0-5). The higher the score, the less active the older person is.
Time frame: At baseline, 3, 6, 9 and 12 months after study inclusion
Weight evolution
The weight of a person (in kilograms) measured with a scale.
Time frame: At baseline, 3, 6, 9 and 12 months after study inclusion
Patient anxiety
Patient anxiety measured by the Hospital Anxiety and Depression Scale (HADS). The 14 questions can be answered by a 4-point Likert scale (0-3). The odd questions (1, 3, 5, 7, 9, 11, 13) refer to fear (score: 0-21). The higher a person scores on this questionnaire, the more complaints of anxiety he/she experiences.
Time frame: At baseline, 3, 6, 9 and 12 months after study inclusion
Patient institutionalisation
Proportion of patients institutionalised (see definition) (range: 0-100%). Definition: Institutionalisation means that a patient moves permanently to an institution among which are considered retirement houses.
Time frame: At baseline, 6 and 12 months after study inclusion
Patient unscheduled hospitalisations
Proportion of patients with at leas one unscheduled hospitalisation and number of unscheduled hospitalisations per patient (see definition) (range: 0-100%). Definition: Unscheduled hospitalisation includes any hospitalisation which has not been previously planned because of an unscheduled event (severe adverse event, complication of treatment, decompensation of morbidity) whatever it is linked or not to the emergency room.
Time frame: During 12 months after study inclusion
Cost-effectiveness and cost-utility evaluation (1)
Life years gained (LYG) in the cost per life years gained (CEA) derived from a clinical metric (overall survival/progression-free survival).
Time frame: During 12 months after study inclusion
Cost-effectiveness and cost-utility evaluation (2)
Quality-adjusted life years (QALYs) in the cost per QALY gained (CUA) calculated using utility assessed through normalised scores of EQ-5D-5L questionnaire. It includes the 5-level questions covering five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. This results in a 5-digit code for EQ-5D-5L, which reflects how good or bad a health state is according to the preferences of the general population of a country/region (score: 11111-55555 (or 99999 for missing data)).
Time frame: At baseline, 3, 6, 9 and 12 months after study inclusion
Cost-effectiveness and cost-utility evaluation (3)
Total amount resulting from all direct (medical or non-medical) and indirect costs related to disease and care, collected during the 12 months of patient follow-up.
Time frame: During 12 months after study inclusion
Caregiver burden
Total burden of the caregiver in health, psychological well-being, finances, social life and relationship with the patient will be obtained using the Zarit Burden Interview (ZBI) by adding the scores across all 22 items. Each question is scored on a 5-point scale (score: 0-88). The higher the score, the heavier the caregiver burden.
Time frame: At baseline, 3, 6, 9 and 12 months after study inclusion
Patient reported overall experience
Patient experience of person-centred coordinated care measured through the Person-Centred Coordinated Care Experience Questionnaire (P3CEQ) - 11 items in 5 domains: information and communication processes, care planning, transitions, goals and outcomes and decision making.
Time frame: At 6 and 12 months after study inclusion
Patient, physician and health-care-professionals-reported overall satisfaction with the IC technology of the GerOnTe intervention
Patient satisfaction and usability of mHealth application within the GerOnTe intervention will be evaluated by using the score derived from the 21-items mHealth App Usability Questionnaire (MAUQ) for standalone mHealth Apps (Patient version). Physician and health-professional satisfaction and usability of mHealth application within the GerOnTe intervention will be evaluated by using the score derived from the adjusted version designed for health care providers of the mHealth App Usability Questionnaire (MAUQ) for standalone mHealth Apps (Provider version), consisted of 18 items.
Time frame: At 6 and 12 months after study inclusion
GerOnTe patient-centred system implementation and usage (1)
Number of connections to the Holis Patient App.
Time frame: At 6 and 12 months after study inclusion
GerOnTe patient-centred system implementation and usage (2)
Frequency of connections to the Holis Patient App.
Time frame: At 6 and 12 months after study inclusion
GerOnTe patient-centred system implementation and usage (3)
Duration of logins and activities with the Holis Patient App,
Time frame: At 6 and 12 months after study inclusion
GerOnTe patient-centred system implementation and usage (4)
Number of web-based meetings with Advanced Practice Nurse by site.
Time frame: At 6 and 12 months after study inclusion
GerOnTe patient-centred system implementation and usage (5)
Number of Advance Practice Nurse (APN) consultations by site (and by patient).
Time frame: At 6 and 12 months after study inclusion
GerOnTe patient-centred system implementation and usage (6)
Number of Patient Reported Outcome Measures (PROM's) dashboards completed by patient (Holis Patient App).
Time frame: At 6 and 12 months after study inclusion
GerOnTe patient-centred system implementation and usage
Number of health professional meetings (Multidisciplinary Tumour Boards (MTB) or other morbidities treatment decision) involving complete dashboards analysis by site.
Time frame: At 6 and 12 months after study inclusion