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Status:

WITHDRAWN

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

Lead Sponsor:

Universitaire Ziekenhuizen KU Leuven

Collaborating Sponsors:

University of Bordeaux

Diakonessenhuis, Utrecht

Conditions:

Geriatrics

Medical Oncology

Eligibility:

All Genders

70+ years

Phase:

NA

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 Professio...

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 Professio...

Eligibility Criteria

Inclusion

  • General inclusion criteria:
  • Age ≥ 70 years old,
  • New or progressive cancer (breast, lung, colorectal, prostate) fulfilling the tumour specific inclusion criteria,
  • Estimated life expectancy greater than 6 months,
  • At least one moderate/severe multimorbidity inclusion criteria other than current cancer (separate list),
  • Patients must be willing and able to comply with study procedures,
  • Voluntarily signed and dated written informed consents prior to any study specific procedure,
  • 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.
  • 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).
  • 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:
  • 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
  • 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.

Exclusion

    Key Trial Info

    Start Date :

    June 1 2024

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    August 8 2024

    Estimated Enrollment :

    Patients enrolled

    Trial Details

    Trial ID

    NCT05423808

    Start Date

    June 1 2024

    End Date

    August 8 2024

    Last Update

    August 12 2024

    Active Locations (1)

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    Page 1 of 1 (1 locations)

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    UZ Gasthuisberg Leuven

    Leuven, Belgium, B-3000