Patients in the intervention group will be part of a renewed care pathway supported by digital tools.

Patients in the control group will receive standard of care, specific to the hospital where the patient is being treated.

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.

Health Professional Consortium

Holis Dashboard - Holis Patient App

Hans Wildiers, prof. dr.

Cindy Kenis, PhD

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.

stepped wedge randomized controlled trial (cross-over type)

Geriatric and Oncological Evaluation With Technology for Holistic Healthcare Management for Older Multimorbid Patients.

Streamlined Geriatric and Oncological Evaluation Based on IC Technology for Holistic Patient-oriented Healthcare Management for Older Multimorbid Patients. TWOBE Study

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.

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.

Survival as the length of time from the start of treatment and death from any cause.

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.

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).

Proportion of patients living at home (range: 0-100%). The higher the percentage, the more patients live at home.

Number of completed chair stands in 30 seconds measured by the Chair Stand Test. Participants stand up repeatedly from a chair for 30 seconds.

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.

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.

The weight of a person (in kilograms) measured with a scale.

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.

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.

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.

Life years gained (LYG) in the cost per life years gained (CEA) derived from a clinical metric (overall survival/progression-free survival).

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)).

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.

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.

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.

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.

Number of connections to the Holis Patient App.

Frequency of connections to the Holis Patient App.

Duration of logins and activities with the Holis Patient App,

Number of web-based meetings with Advanced Practice Nurse by site.

Number of Advance Practice Nurse (APN) consultations by site (and by patient).

Number of Patient Reported Outcome Measures (PROM's) dashboards completed by patient (Holis Patient App).

Number of health professional meetings (Multidisciplinary Tumour Boards (MTB) or other morbidities treatment decision) involving complete dashboards analysis by site.

Spots Global Cancer Trial Database for critical pathways