Streamlined Geriatric and Oncological evaluation based on IC Technology for holistic patient-oriented healthcare management for older multimorbid patients - TWOBE study
- Conditions
- Borst-, long-, prostaat- en colorectale kankercancercomorbidity
- Registration Number
- NL-OMON53890
- Lead Sponsor
- niversitaire Ziekenhuizen Leuven (UZ Leuven)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 360
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
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:
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
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:
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.
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 treatme
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>PRIMARY ENDPOINT<br /><br>Quality of life assessed by the EORTC QLQ-C30 questionnaire at 6 months after<br /><br>GerOnTe inclusion using 3 derived scores of the QLQ-C30 questionnaire:<br /><br>• Normalized global health status score<br /><br>• Normalized score of the physical functioning scale<br /><br>• Normalized score of the emotional functioning scale </p><br>
- Secondary Outcome Measures
Name Time Method