NL-OMON53890尚未招募不适用
Streamlined Geriatric and Oncological evaluation based on IC Technology for holistic patient-oriented healthcare management for older multimorbid patients - TWOBE study - GerOnTe TWOBE
niversitaire Ziekenhuizen Leuven (UZ Leuven)0 个研究点目标入组 360 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 360
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 65 至 99（—）
入选标准
- •General inclusion criteria
- •1. Age >= 70 years old.
- •2. New or progressive cancer (breast, lung, colorectal, prostate) fulfilling
- •the tumour specific criteria.
- •3. Estimated life expectancy greater than 6 months.
- •4. At least one moderate/severe multimorbidity inclusion criteria other than
- •current cancer (see separate list under 5.3).
- •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
- •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:
- •o Clinical staging: cT2-3-4 Nany, or cTany N1-2-3,
- •o The cancer specialist considers* surgery,
- •o 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
- •**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:
- •o The cancer specialist considers* surgery,
- •o The cancer specialist considers* radiotherapy,
- •o 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:
- •o The cancer specialist considers* surgery (patients considered for treatment
- •with percutaneous thermoablation alone are not eligible),
- •o The cancer specialist considers* radiotherapy (except SBRT),
- •o The cancer specialist considers* systemic therapy. Possible systemic
- •therapies are chemotherapy and/or immune therapy and/or targeted therapy.
- 另有 8 项未显示
排除标准
- •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.
- •Protocol: page number 26
研究者
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