NCT05423808撤回不适用
Streamlined Geriatric and Oncological Evaluation Based on IC Technology for Holistic Patient-oriented Healthcare Management for Older Multimorbid Patients. TWOBE Study
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Quality of Life (QoL): EORTC QLQ-C30
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
- •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.
- •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.
- •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.
- •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.
- •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.
- •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.
- •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).
- •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.
- 另有 1 项未显示
排除标准
- •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:
- •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).
- •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.
- •Previous vascular intervention.
- •Symptomatic atherosclerotic/peripheral vascular disease.
- •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).
- •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.
- •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.
- •eGFR < 30 ml/min.
- •Hepatobilary
- •Chronic hepatitis.
- •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.
- 另有 34 项未显示
研究组 & 干预措施
Intervention group
Experimental
Patients in the intervention group will be part of a renewed care pathway supported by digital tools.
干预措施: Health Professional Consortium (Other)
Intervention group
Experimental
Patients in the intervention group will be part of a renewed care pathway supported by digital tools.
干预措施: Holis Dashboard - Holis Patient App (Device)
Control group
No Intervention
Patients in the control group will receive standard of care, specific to the hospital where the patient is being treated.
结局指标
主要结局
Quality of Life (QoL): EORTC QLQ-C30
时间窗: QoL at 6 months after study inclusion
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.
次要结局
- GerOnTe patient-centred system implementation and usage (6)(At 6 and 12 months after study inclusion)
- GerOnTe patient-centred system implementation and usage (1)(At 6 and 12 months after study inclusion)
- GerOnTe patient-centred system implementation and usage (4)(At 6 and 12 months after study inclusion)
- Progression-free survival(at 12 months after study inclusion)
- Overall survival(at 12 months after study inclusion)
- Patient autonomy (2)(At 6 and 12 months after study inclusion)
- Patient unscheduled hospitalisations(During 12 months after study inclusion)
- Cost-effectiveness and cost-utility evaluation (1)(During 12 months after study inclusion)
- Weight evolution(At baseline, 3, 6, 9 and 12 months after study inclusion)
- Cost-effectiveness and cost-utility evaluation (3)(During 12 months after study inclusion)
- Quality of Life (QoL): EORTC QLQ-C30(QoL at 3, 9 and 12 months after study inclusion)
- Patient autonomy (1)(At baseline, 3, 6, 9 and 12 months after study inclusion)
- Patient autonomy (3)(At baseline, 3, 6, 9 and 12 months after study inclusion)
- Patient institutionalisation(At baseline, 6 and 12 months after study inclusion)
- Cost-effectiveness and cost-utility evaluation (2)(At baseline, 3, 6, 9 and 12 months after study inclusion)
- Caregiver burden(At baseline, 3, 6, 9 and 12 months after study inclusion)
- Patient reported overall experience(At 6 and 12 months after study inclusion)
- Patient autonomy (4)(At baseline, 3, 6, 9 and 12 months after study inclusion)
- Patient autonomy (5)(At baseline, 3, 6, 9 and 12 months after study inclusion)
- Patient anxiety(At baseline, 3, 6, 9 and 12 months after study inclusion)
- GerOnTe patient-centred system implementation and usage (2)(At 6 and 12 months after study inclusion)
- GerOnTe patient-centred system implementation and usage (5)(At 6 and 12 months after study inclusion)
- Patient, physician and health-care-professionals-reported overall satisfaction with the IC technology of the GerOnTe intervention(At 6 and 12 months after study inclusion)
- GerOnTe patient-centred system implementation and usage (3)(At 6 and 12 months after study inclusion)
- GerOnTe patient-centred system implementation and usage(At 6 and 12 months after study inclusion)
研究者
研究点 (1)
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