Clinical trial NCT05423808: Geriatric and Oncological Evaluation With Technology for Holistic Healthcare Management for Older Multimorbid Patients.
Official title: Streamlined Geriatric and Oncological Evaluation Based on IC Technology for Holistic Patient-oriented Healthcare Management for Older Multimorbid Patients. TWOBE Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Geriatrics
Medical Oncology
Critical Pathways
Digital Technology
Keywords: Geriatrics
Oncology
Patient-centred care
Technology
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
Collaborators: name: University of Bordeaux
name: Diakonessenhuis, Utrecht
name: University of Milan
name: University College Dublin
name: Oslo University Hospital
name: International Society of Geriatric Oncology
name: Dublin City University
name: Universitair Ziekenhuis Brussel
name: General Hospital Groeninge
name: AZ Sint-Jan AV
name: Catharina Ziekenhuis Eindhoven
name: Reinier de Graaf Groep
name: KU Leuven
First posted: 2022-06-21
Enrollment: 0
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: stepped wedge randomized controlled trial (cross-over type)
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Quality of Life (QoL): EORTC QLQ-C30
timeFrame: QoL at 6 months after study inclusion
Secondary outcomes:
measure: Quality of Life (QoL): EORTC QLQ-C30
timeFrame: QoL at 3, 9 and 12 months after study inclusion
measure: Overall survival
timeFrame: at 12 months after study inclusion
measure: Progression-free survival
timeFrame: at 12 months after study inclusion
measure: Patient autonomy (1)
timeFrame: At baseline, 3, 6, 9 and 12 months after study inclusion
measure: Patient autonomy (2)
timeFrame: At 6 and 12 months after study inclusion
measure: Patient autonomy (3)
timeFrame: At baseline, 3, 6, 9 and 12 months after study inclusion
measure: Patient autonomy (4)
timeFrame: At baseline, 3, 6, 9 and 12 months after study inclusion
measure: Patient autonomy (5)
timeFrame: At baseline, 3, 6, 9 and 12 months after study inclusion
measure: Weight evolution
timeFrame: At baseline, 3, 6, 9 and 12 months after study inclusion
measure: Patient anxiety
timeFrame: At baseline, 3, 6, 9 and 12 months after study inclusion
measure: Patient institutionalisation
timeFrame: At baseline, 6 and 12 months after study inclusion
measure: Patient unscheduled hospitalisations
timeFrame: During 12 months after study inclusion
measure: Cost-effectiveness and cost-utility evaluation (1)
timeFrame: During 12 months after study inclusion
measure: Cost-effectiveness and cost-utility evaluation (2)
timeFrame: At baseline, 3, 6, 9 and 12 months after study inclusion
measure: Cost-effectiveness and cost-utility evaluation (3)
timeFrame: During 12 months after study inclusion
measure: Caregiver burden
timeFrame: At baseline, 3, 6, 9 and 12 months after study inclusion
measure: Patient reported overall experience
timeFrame: At 6 and 12 months after study inclusion
measure: Patient, physician and health-care-professionals-reported overall satisfaction with the IC technology of the GerOnTe intervention
timeFrame: At 6 and 12 months after study inclusion
measure: GerOnTe patient-centred system implementation and usage (1)
timeFrame: At 6 and 12 months after study inclusion
measure: GerOnTe patient-centred system implementation and usage (2)
timeFrame: At 6 and 12 months after study inclusion
measure: GerOnTe patient-centred system implementation and usage (3)
timeFrame: At 6 and 12 months after study inclusion
measure: GerOnTe patient-centred system implementation and usage (4)
timeFrame: At 6 and 12 months after study inclusion
measure: GerOnTe patient-centred system implementation and usage (5)
timeFrame: At 6 and 12 months after study inclusion
measure: GerOnTe patient-centred system implementation and usage (6)
timeFrame: At 6 and 12 months after study inclusion
measure: GerOnTe patient-centred system implementation and usage
timeFrame: At 6 and 12 months after study inclusion
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: UZ Gasthuisberg Leuven
Study officials:
affiliation: Coordinator multidisciplinary breast centre (MBC)
name: Hans Wildiers, prof. dr.
role: PRINCIPAL_INVESTIGATOR
References: