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GeriatricsGerOnTe-TWOBENCT05423808

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

A study testing Health Professional Consortium and Holis Dashboard - Holis Patient App in people with Geriatrics and Medical Oncology, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 70 years and older
Conditions the study is for
Geriatrics, Medical Oncology, Critical Pathways
What is being tested?
Health Professional Consortium and Holis Dashboard - Holis Patient App
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteBelgium
Study dates
Jun 2024to 8 Aug 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 70 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

None listed.

Who cannot join

  • Mental illness/cognitive impairment that limits ability to provide consent or complete trial procedures.
  • Participating to an interventional clinical trial with a non-registered anticancer drug or to another geriatric intervention trial.
  • Patients and caregivers are unable or unwilling to use ICT-devices (tablet, computer, smartphone) or the Internet according to protocol.
  • Patient already included in this study.
  • Separate list of severe morbidity criteria:
  • General
Show all 96Show fewer
  • Two or more unscheduled comorbidity related hospitalisations in the past year (not related to index cancer).
  • Having received out-patient care from two more specialties in the past year (not related to index cancer).
  • Cardiac
  • Any prior symptomatic myocardial infarction.
  • Any past valve replacement, percutaneous coronary intervention), percutaneous transluminal coronary angioplasty) or coronary artery bypass graft.
  • Congestive heart failure under follow-up by a cardiologist.
  • Chronic exertional angina.
  • Regular use of anti-anginal medication.
  • Left ventricular hypertrophy.
  • Dyspnoea or activity restriction secondary to cardiac status.
  • One or more admissions to hospital for cardiac reasons in past year.
  • Vascular
  • Previous vascular intervention.
  • Symptomatic atherosclerotic/peripheral vascular disease.
  • Venous
  • Any history of pulmonary embolism.
  • Use of coumadin/warfarin, heparin, DOAC or NOAC with indication venous disease.
  • Hypertension
  • Need of three or more types of blood pressure medication.
  • Haematopoetic
  • Any chronic hematologic disease.
  • Haemoglobin: <10 g/dL (6.0 mmol/l) (not related to index cancer).
  • Endocrine
  • Insulin dependence.
  • Diabetes-related complications (retinopathy, neuropathy, nephropathy, coronary artery disease or peripheral arterial disease).
  • Poorly controlled diabetes mellitus or diabetic coma in the past year.
  • Requires adrenal hormone replacement.
  • Pulmonary
  • Dyspnoea at rest.
  • Limited activities secondary to pulmonary status.
  • Requires oral steroids for lung disease.
  • One or more admissions to hospital for pulmonary reasons in past year.
  • Two or more hospitalisations for pneumonia in past five years.
  • Renal
  • eGFR < 30 ml/min.
  • Hepatobilary
  • Chronic hepatitis.
  • Cirrhosis.
  • Portal hypertension with moderate symptoms.
  • Compensated liver failure.
  • Clinical or lab evidence of biliary obstruction (not related to index cancer).
  • Acute or chronic pancreatitis or hepatitis in past 5 years.
  • Stomach/intestine
  • Recent ulcers (<6 months) or any history of ulcers requiring hospitalisation.
  • Any history of inflammatory bowel disease.
  • Any swallowing disorder or dysphagia.
  • Chronic diarrhoea (not related to index cancer).
  • Bowel impaction in the past year (not related to index cancer).
  • Status post bowel obstruction (not related to index cancer).
  • Ostomy/stoma in situ (not related to index cancer).
  • Nutrition and weight
  • Weight loss more than 6 kg in past six months.
  • Weight loss more than 3 kg in past 1 month.
  • Significantly decreased food intake.
  • Body mass index < 19 kg/m2.
  • Body mass index > 38 kg/m2.
  • Neurologic
  • Status post cerebrovascular accident (CVA) with at least mild residual dysfunction.
  • Any past central nervous system neurosurgical procedure.
  • Neurodegenerative disease including Parkinson's disease, parkinsonism, multiple sclerosis, myasthenia gravis etc.).
  • Requires daily meds for chronic headaches or headaches that regularly interfere with daily activities.
  • Sensory
  • Partially or functionally blind, unable to read newsprint.
  • Functional deafness or conversational hearing impaired despite hearing aid.
  • Laryngectomy.
  • Mobility
  • Requires a walking aid/wheelchair.
  • Difficulties in activities of daily living secondary to mobility impairment.
  • Difficulty walking >100m without resting.
  • Requires steroids or immunosuppressant medication for arthritic condition or connective tissue disease.
  • Prior or current symptomatic vertebral compression fractures from osteoporosis.
  • Psychiatric
  • Active substance abuse with social, behavioural or medical complications.
  • History of schizophrenia or another psychotic disorder.
  • Requires daily antipsychotic medication.
  • Current usage of daily anti-anxiety medication.
  • Currently meets DSM criteria for major depression or bipolar disorder.
  • One or more episodes of major depression in the past 10 years.
  • Any previous psychiatric hospitalisation.
  • Cognition/Delirium
  • One or more prior deliriums in the past 10 years.
  • Cognitive impairment that does not inhibit patient to provide informed consent and understand study procedures.
  • Previous cancer
  • Another type of cancer than the index cancer with at least one of the following criteria:
  • Required chemotherapy or radiation therapy in the past 5 years,
  • Non-curable and/or metastatic cancer.
  • Instrumental Activities of Daily Living (IADL)
  • Care dependent in one or more aspects of the following instrumental activities of daily living (preparing meals, walking outside alone, managing medication).
  • Social
  • Patients has no or very limited support system or informal caregivers.

Trial locations and contacts

1 site in 1 country.

Belgium1 site
  • UZ Gasthuisberg Leuven

    Leuven, B-3000

Other trials in Belgium

About this study

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

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.

Read the detailed description

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.

Being tested
Health Professional Consortium, Holis Dashboard - Holis Patient App
Keywords
Geriatrics, Oncology, Patient-centred care, Technology
Medical subject headings
Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Health Professional ConsortiumOther

    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.

  • Holis Dashboard - Holis Patient AppDevice

    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.

Study groups in NCT05423808
Study groupRoleWhat they receive
Intervention groupExperimentalPatients in the intervention group will be part of a renewed care pathway supported by digital tools.
Receives: Other: Health Professional Consortium; Device: Holis Dashboard - Holis Patient App
Control groupNo interventionPatients in the control group will receive standard of care, specific to the hospital where the patient is being treated.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: QoL at 6 months after study inclusion

Secondary outcomes (25)
  1. 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.

    Measured: QoL at 3, 9 and 12 months after study inclusion

  2. Overall survival

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

    Measured: at 12 months after study inclusion

  3. 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.

    Measured: at 12 months after study inclusion

  4. 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).

    Measured: At baseline, 3, 6, 9 and 12 months after study inclusion

  5. Patient autonomy (2)

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

    Measured: At 6 and 12 months after study inclusion

  6. 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.

    Measured: At baseline, 3, 6, 9 and 12 months after study inclusion

  7. 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.

    Measured: At baseline, 3, 6, 9 and 12 months after study inclusion

  8. 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.

    Measured: At baseline, 3, 6, 9 and 12 months after study inclusion

  9. Weight evolution

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

    Measured: At baseline, 3, 6, 9 and 12 months after study inclusion

  10. 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.

    Measured: At baseline, 3, 6, 9 and 12 months after study inclusion

  11. 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.

    Measured: At baseline, 6 and 12 months after study inclusion

  12. 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.

    Measured: During 12 months after study inclusion

  13. 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).

    Measured: During 12 months after study inclusion

  14. 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)).

    Measured: At baseline, 3, 6, 9 and 12 months after study inclusion

  15. 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.

    Measured: During 12 months after study inclusion

  16. 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.

    Measured: At baseline, 3, 6, 9 and 12 months after study inclusion

  17. 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.

    Measured: At 6 and 12 months after study inclusion

  18. 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.

    Measured: At 6 and 12 months after study inclusion

  19. GerOnTe patient-centred system implementation and usage (1)

    Number of connections to the Holis Patient App.

    Measured: At 6 and 12 months after study inclusion

  20. GerOnTe patient-centred system implementation and usage (2)

    Frequency of connections to the Holis Patient App.

    Measured: At 6 and 12 months after study inclusion

  21. GerOnTe patient-centred system implementation and usage (3)

    Duration of logins and activities with the Holis Patient App,

    Measured: At 6 and 12 months after study inclusion

  22. GerOnTe patient-centred system implementation and usage (4)

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

    Measured: At 6 and 12 months after study inclusion

  23. GerOnTe patient-centred system implementation and usage (5)

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

    Measured: At 6 and 12 months after study inclusion

  24. GerOnTe patient-centred system implementation and usage (6)

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

    Measured: At 6 and 12 months after study inclusion

  25. 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.

    Measured: At 6 and 12 months after study inclusion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jun 2022
  2. Study startJun 2024 (estimated)
  3. Primary completion8 Aug 2024
  4. Study completion8 Aug 2024

Why it stopped: important delays in digital health tool development made the timelines unfeasible within the project

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Crossover
Model description
stepped wedge randomized controlled trial (cross-over type)
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05423808
Sponsor's protocol ID
s66300
Acronym
GerOnTe-TWOBE
Status last verified
Dec 2023
First submitted
7 Jun 2022
Last updated
12 Aug 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Hamaker ME, Wildiers H, Ardito V, Arsandaux J, Barthod-Malat A, Davies P, Degol L, Ferrara L, Fourrier C, Kenis C, Kret M, Lalet C, Pelissier SM, O'Hanlon S, Rostoft S, Seghers N, Saillour-Glenisson F, Staines A, Schwimmer C, Thevenet V, Wallet C, Soubeyran P. Study protocol for two stepped-wedge interventional trials evaluating the effects of holistic information technology-based patient-oriented management in older multimorbid patients with cancer: The GERONTE trials. J Geriatr Oncol. 2024 May;15(4):101761. doi: 10.1016/j.jgo.2024.101761. Epub 2024 Apr 5.

    PubMed 38581958

Questions about this trial

What is this clinical trial studying?

A study testing Health Professional Consortium and Holis Dashboard - Holis Patient App in people with Geriatrics and Medical Oncology, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 96 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 12 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Quality of Life (QoL): EORTC QLQ-C30 (time frame: QoL at 6 months after study inclusion). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05423808, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2024.

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