Geriatric and Oncological Evaluation With Technology for Holistic Healthcare Management for Older Multimorbid Patients.
NCT ID: NCT05423808
Last Updated: 2024-08-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2024-06-30
2024-08-08
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
SUPPORTIVE_CARE
NONE
Study Groups
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Intervention group
Patients in the intervention group will be part of a renewed care pathway supported by digital tools.
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.
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.
Control group
Patients in the control group will receive standard of care, specific to the hospital where the patient is being treated.
No interventions assigned to this group
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
3. Estimated life expectancy greater than 6 months,
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.
* 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.
* 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.
* 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.
* 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
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.
70 Years
ALL
No
Sponsors
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University of Bordeaux
OTHER
Diakonessenhuis, Utrecht
OTHER
University of Milan
OTHER
University College Dublin
OTHER
Oslo University Hospital
OTHER
International Society of Geriatric Oncology
OTHER
Dublin City University
OTHER
Universitair Ziekenhuis Brussel
OTHER
General Hospital Groeninge
OTHER
AZ Sint-Jan AV
OTHER
Catharina Ziekenhuis Eindhoven
OTHER
Reinier de Graaf Groep
OTHER
KU Leuven
OTHER
Universitaire Ziekenhuizen KU Leuven
OTHER
Responsible Party
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Principal Investigators
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Hans Wildiers, prof. dr.
Role: PRINCIPAL_INVESTIGATOR
Coordinator multidisciplinary breast centre (MBC)
Locations
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UZ Gasthuisberg Leuven
Leuven, , Belgium
Countries
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References
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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.
Other Identifiers
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s66300
Identifier Type: -
Identifier Source: org_study_id
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