Borst-, long-, prostaat- en colorectale kanker cancer comorbidity
Conditions
Interventions
The intervention will include the following components:
• A health professional consortium (HPC) for each patient, which will work
together to make recommendations regarding oncologic treatment and
Sponsors
Universitaire Ziekenhuizen Leuven (UZ Leuven)
Eligibility
Age
65 Years to 99 Years
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PRIMARY ENDPOINT Quality of life assessed by the EORTC QLQ-C30 questionnaire at 6 months after GerOnTe inclusion using 3 derived scores of the QLQ-C30 questionnaire: • Normalized global health status score • Normalized score of the physical functioning scale • Normalized score of the emotional functioning scale | — |
Secondary
| Measure | Time frame |
|---|---|
| SECONDARY ENDPOINTS 1. Quality of life • The 3 normalized QLQ-C30 scores at baseline 3, 9 and 12 months • Normalized scores of QLQ-C30 scales/items (role functioning scale, cognitive functioning scale, social functioning scale, fatigue scale, nausea scale, pain scale, dyspnea item, insomnia item, appetite loss item, constipation item, diarrhea item and financial difficulties item) at baseline, 3, 6, 9 and 12 months. • Scores of QLQ-ELD14 scales/items (mobility scale, worries about others scale, future worries scale, maintaining purpose scale, burden of illness scale, joint stiffness item, family support item) at baseline, 3, 6, 9 and 12 months 2. Survival: Overall survival at 12 months and progression-free survival (the time from study treatment initiation to the first occurrence of disease progression or death, whichever occurs first). 3. Patient autonomy, frailty and weight evolution • Dependence score of the Activities of Daily Living scale (Katz ADL) at baseline, 3, 6, 9 and 12 months, • Proportion of patients living at home at 6 and 12 months, • Number of completed chair stands in 30 seconds (Chair stand test) at baseline, 3, 6, 9 and 12 months, • Score of the Clinical Frailty Scale at baseline, 3, 6, 9 and 12 months, • Grade of performance status, measured by ECOG-PS at baseline, 3, 6, 9 and 12 months, • Weight at baseline, 3, 6, 9 and 12 months. 4. Patient anxiety: Score of Hospital Anxiety and Depression Scale (HADS) at baseline, 3, 6, 9 and 12 months. 5. Proportion of patient institutionalized and number of unscheduled hospitalisations per participants at 6 and 12 months. 6. Cost per life years gained (CEA, derived from survival/progression-free survival), cost per QALY gained (CUA, using utility assessed through normalized scores of EQ-5D-5L questionnaire collected at baseline, at 3, 6, 9 and 12 months after inclusion) and incremental cost-effectiveness ratios (ICERs) obtained by a cost-utility and a cost-effectiveness analy | — |
Countries
Netherlands
Outcome results
None listed