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

Geriatrics Clinical Trial

— GerOnTe-TWOBE  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05423808
• Other study ID #: s66300
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2024
• Est. completion date: September 2026

Study information

• Verified date: December 2023
• Source: Universitaire Ziekenhuizen KU Leuven
• Contact: Hans Wildiers, prof. dr.
• Phone: +32 16 34 69 20
• Email: hans.wildiers[@]uzleuven.be
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 hospitals.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 720
• Est. completion date: September 2026
• Est. primary completion date: March 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years and older

Eligibility

General inclusion criteria:

1. Age = 70 years old,

2. New or progressive cancer (breast, lung, colorectal, prostate) fulfilling the tumour specific inclusion criteria,

3. Estimated life expectancy greater than 6 months,

4. At least one moderate/severe multimorbidity inclusion criteria other than current cancer (separate list),

5. Patients must be willing and able to comply with study procedures,

6. Voluntarily signed and dated written informed consents prior to any study specific procedure,

7. QLQ-C30 Quality of Life Questionnaire fully completed at baseline, before inclusion.

Tumour specific inclusion criteria:

8. Specific inclusion criteria for breast cancer: 8.1. Non-metastatic breast cancer (M0):

• No prior treatment for the current breast cancer.

• All 3 criteria required:

• Clinical staging: cT2-3-4 Nany, or cTany N1-2-3,

• The cancer specialist considers* surgery,

• The cancer specialist considers* radiotherapy and/or chemotherapy. 8.2. Metastatic breast cancer (M1): Both criteria required:

• The cancer specialist considers* chemotherapy or PARP-inhibitors or mTOR-inhibitors / PIK3CA inhibitors; Previous endocrine therapy +/- CDK4/6 inhibitors is allowed,

• The patient received maximum 1 prior line of chemotherapy for metastatic disease.

*'consider' implies that this treatment may be a treatment option for this patient in this particular setting. If at a later point, a different treatment choice is made, the patient remains eligible.

9. Specific inclusion criteria for colorectal cancer: 9.1. Non-metastatic colorectal cancer (M0):

• No prior therapy for the current tumour in the recruiting hospital.

• At least one of the 3 criteria required:

• The cancer specialist considers* surgery,

• The cancer specialist considers* radiotherapy,

• The cancer specialist considers* chemotherapy. 9.2. Metastatic colorectal cancer (M1):

• The cancer specialist considers* first line systemic therapy and/or radiotherapy (+/- surgery). No previous chemotherapy allowed except adjuvant/perioperative chemotherapy stopped for more than 12 months.

*'consider' implies that this treatment may be a treatment option for this patient in this particular setting. If at a later point, a different treatment choice is made, the patient remains eligible.

10. Specific inclusion criteria for lung cancer: 10.1. Non-metastatic lung cancer (M0):

• No prior therapy for the current tumour in the recruiting hospital.

• At least one of the 3 criteria required:

• The cancer specialist considers* surgery (patients considered for treatment with percutaneous thermoablation alone are not eligible),

• The cancer specialist considers* radiotherapy (except SBRT),

• The cancer specialist considers* systemic therapy. Possible systemic therapies are chemotherapy and/or immune therapy and/or targeted therapy. Patients only considered* for monotherapy with anti-EGFR TKI or somatostatin analog are not eligible.

10.2. Metastatic lung cancer (M1):

• The cancer specialist considers* first or second line systemic therapy. Possible systemic therapies are chemotherapy and/or immune therapy and/or targeted therapy. Patients only considered* for monotherapy with anti-EGFR TKI or somatostatin analog are not eligible.

*'consider' implies that this treatment may be a treatment option for this patient in this particular setting. If at a later point, a different treatment choice is made, the patient remains eligible.

11. Specific inclusion criteria for prostate cancer: 11.1. Non-metastatic prostate cancer (M0): one of the following:

• First diagnosis M0 prostate cancer (no therapy received yet for prostate cancer): at least one of the 2 criteria required:

• The cancer specialist considers* radiotherapy,

• The cancer specialist considers* hormone therapy (ADT +/- combination Abiraterone and Prednisone).

• Salvage treatment M0 prostate cancer (received prior surgery at least 6 months before):

• The cancer specialist considers* radiotherapy (+/- ADT).

• Non-metastatic castration resistant prostate cancer:

• The cancer specialist considers* treatment intensification (ADT + Enzalutamide or Apalutamide or Darolutamide).

11.2. Metastatic prostate cancer (M1): • The cancer specialist considers* treatment with Abiraterone or Enzalutamide or Apalutamide, or Docetaxel or Cabazitaxel or PARP-inhibitors or Lutetium PSMA.

*'consider' implies that this treatment may be a treatment option for this patient in this particular setting. If at a later point, a different treatment choice is made, the patient remains eligible.

Exclusion criteria:

1. Mental illness/cognitive impairment that limits ability to provide consent or complete trial procedures.

2. Participating to an interventional clinical trial with a non-registered anticancer drug or to another geriatric intervention trial.

3. Patients and caregivers are unable or unwilling to use ICT-devices (tablet, computer, smartphone) or the Internet according to protocol.

4. Patient already included in this study.

Separate list of severe morbidity criteria:

General

1. Two or more unscheduled comorbidity related hospitalisations in the past year (not related to index cancer).

2. Having received out-patient care from two more specialties in the past year (not related to index cancer).

Cardiac

3. Any prior symptomatic myocardial infarction.

4. Any past valve replacement, percutaneous coronary intervention), percutaneous transluminal coronary angioplasty) or coronary artery bypass graft.

5. Congestive heart failure under follow-up by a cardiologist.

6. Chronic exertional angina.

7. Regular use of anti-anginal medication.

8. Left ventricular hypertrophy.

9. Dyspnoea or activity restriction secondary to cardiac status.

10. One or more admissions to hospital for cardiac reasons in past year.

Vascular

11. Previous vascular intervention.

12. Symptomatic atherosclerotic/peripheral vascular disease.

Venous

13. Any history of pulmonary embolism.

14. Use of coumadin/warfarin, heparin, DOAC or NOAC with indication venous disease.

Hypertension

15. Need of three or more types of blood pressure medication.

Haematopoetic

16. Any chronic hematologic disease.

17. Haemoglobin: <10 g/dL (6.0 mmol/l) (not related to index cancer).

Endocrine

18. Insulin dependence.

19. Diabetes-related complications (retinopathy, neuropathy, nephropathy, coronary artery disease or peripheral arterial disease).

20. Poorly controlled diabetes mellitus or diabetic coma in the past year.

21. Requires adrenal hormone replacement.

Pulmonary

22. Dyspnoea at rest.

23. Limited activities secondary to pulmonary status.

24. Requires oral steroids for lung disease.

25. One or more admissions to hospital for pulmonary reasons in past year.

26. Two or more hospitalisations for pneumonia in past five years.

Renal

27. eGFR < 30 ml/min.

Hepatobilary

28. Chronic hepatitis.

29. Cirrhosis.

30. Portal hypertension with moderate symptoms.

31. Compensated liver failure.

32. Clinical or lab evidence of biliary obstruction (not related to index cancer).

33. Acute or chronic pancreatitis or hepatitis in past 5 years.

Stomach/intestine

34. Recent ulcers (<6 months) or any history of ulcers requiring hospitalisation.

35. Any history of inflammatory bowel disease.

36. Any swallowing disorder or dysphagia.

37. Chronic diarrhoea (not related to index cancer).

38. Bowel impaction in the past year (not related to index cancer).

39. Status post bowel obstruction (not related to index cancer).

40. Ostomy/stoma in situ (not related to index cancer).

Nutrition and weight

41. Weight loss more than 6 kg in past six months.

42. Weight loss more than 3 kg in past 1 month.

43. Significantly decreased food intake.

44. Body mass index < 19 kg/m2.

45. Body mass index > 38 kg/m2.

Neurologic

46. Status post cerebrovascular accident (CVA) with at least mild residual dysfunction.

47. Any past central nervous system neurosurgical procedure.

48. Neurodegenerative disease including Parkinson's disease, parkinsonism, multiple sclerosis, myasthenia gravis etc.).

49. Requires daily meds for chronic headaches or headaches that regularly interfere with daily activities.

Sensory

50. Partially or functionally blind, unable to read newsprint.

51. Functional deafness or conversational hearing impaired despite hearing aid.

52. Laryngectomy.

Mobility

53. Requires a walking aid/wheelchair.

54. Difficulties in activities of daily living secondary to mobility impairment.

55. Difficulty walking >100m without resting.

56. Requires steroids or immunosuppressant medication for arthritic condition or connective tissue disease.

57. Prior or current symptomatic vertebral compression fractures from osteoporosis.

Psychiatric

58. Active substance abuse with social, behavioural or medical complications.

59. History of schizophrenia or another psychotic disorder.

60. Requires daily antipsychotic medication.

61. Current usage of daily anti-anxiety medication.

62. Currently meets DSM criteria for major depression or bipolar disorder.

63. One or more episodes of major depression in the past 10 years.

64. Any previous psychiatric hospitalisation.

Cognition/Delirium

65. One or more prior deliriums in the past 10 years.

66. Cognitive impairment that does not inhibit patient to provide informed consent and understand study procedures.

Previous cancer

67. 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)

68. Care dependent in one or more aspects of the following instrumental activities of daily living (preparing meals, walking outside alone, managing medication).

Social

69. Patients has no or very limited support system or informal caregivers.

Related Conditions & MeSH terms

• Critical Pathways
• Geriatrics
• Medical Oncology
• Neoplasms

Intervention

Other:
• Health Professional Consortium
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.

Device:
• Holis Dashboard - Holis Patient App
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.

Locations

Country	Name	City	State
Belgium	UZ Gasthuisberg Leuven	Leuven

Sponsors (14)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen KU Leuven	AZ Sint-Jan AV, Catharina Ziekenhuis Eindhoven, Diakonessenhuis, Utrecht, Dublin City University, General Hospital Groeninge, International Society of Geriatric Oncology, KU Leuven, Oslo University Hospital, Reinier de Graaf Groep, Universitair Ziekenhuis Brussel, University College Dublin, University of Bordeaux, University of Milan

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	QoL at 6 months after study inclusion
Secondary	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.	QoL at 3, 9 and 12 months after study inclusion
Secondary	Overall survival	Survival as the length of time from the start of treatment and death from any cause.	at 12 months after study inclusion
Secondary	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.	at 12 months after study inclusion
Secondary	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).	At baseline, 3, 6, 9 and 12 months after study inclusion
Secondary	Patient autonomy (2)	Proportion of patients living at home (range: 0-100%). The higher the percentage, the more patients live at home.	At 6 and 12 months after study inclusion
Secondary	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.	At baseline, 3, 6, 9 and 12 months after study inclusion
Secondary	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.	At baseline, 3, 6, 9 and 12 months after study inclusion
Secondary	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.	At baseline, 3, 6, 9 and 12 months after study inclusion
Secondary	Weight evolution	The weight of a person (in kilograms) measured with a scale.	At baseline, 3, 6, 9 and 12 months after study inclusion
Secondary	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.	At baseline, 3, 6, 9 and 12 months after study inclusion
Secondary	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.	At baseline, 6 and 12 months after study inclusion
Secondary	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.	During 12 months after study inclusion
Secondary	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).	During 12 months after study inclusion
Secondary	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)).	At baseline, 3, 6, 9 and 12 months after study inclusion
Secondary	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.	During 12 months after study inclusion
Secondary	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.	At baseline, 3, 6, 9 and 12 months after study inclusion
Secondary	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.	At 6 and 12 months after study inclusion
Secondary	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.	At 6 and 12 months after study inclusion
Secondary	GerOnTe patient-centred system implementation and usage (1)	Number of connections to the Holis Patient App.	At 6 and 12 months after study inclusion
Secondary	GerOnTe patient-centred system implementation and usage (2)	Frequency of connections to the Holis Patient App.	At 6 and 12 months after study inclusion
Secondary	GerOnTe patient-centred system implementation and usage (3)	Duration of logins and activities with the Holis Patient App,	At 6 and 12 months after study inclusion
Secondary	GerOnTe patient-centred system implementation and usage (4)	Number of web-based meetings with Advanced Practice Nurse by site.	At 6 and 12 months after study inclusion
Secondary	GerOnTe patient-centred system implementation and usage (5)	Number of Advance Practice Nurse (APN) consultations by site (and by patient).	At 6 and 12 months after study inclusion
Secondary	GerOnTe patient-centred system implementation and usage (6)	Number of Patient Reported Outcome Measures (PROM's) dashboards completed by patient (Holis Patient App).	At 6 and 12 months after study inclusion
Secondary	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.	At 6 and 12 months after study inclusion