Patients with serious, advanced cancer who have undergone guideline-based therapy and patients with rare tumors for which no guideline-based therapy exists were enrolled.
Conditions
Interventions
Group 1: Control patients of the sites, prior to implementation of the intervention: patients who meet the Molecular Tumor Board (MTB) inclusion criteria, but who may not be assessed in the MTB accord
Sponsors
Zentrum für Personalisierte Medizin, Universitätsklinikum Tübingen
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Diagnosis of cancer including progression or recurrence (all cancer entities can be included) 2. Patient should be able to participate in data collection 3. Treatment at one of the participating CCC/ZPMs or patient presented there for a second opinion 4. Molecular diagnostics possible 5. Patient qualifies for the MTB of the center 6. First presentation at the MTB of the center 7. Informed consent = written consent for participation in the study and data transfer
Exclusion criteria
Exclusion criteria: Linguistic or cognitive limitations that result in inability to collect data even with assistance
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in patient management due to MTB decision (calculated based on quantitative questionnaire completed by site staff): - Number of patients admitted to the MTB (T0 = day of initial presentation to the MTB) - Proportion of patients with changed diagnostic strategy and/or therapy recommendation based on tumor board decisions (T1 = day of therapy decision) - Proportion of patients with actually implemented changed diagnostic strategy and/or therapy (T2 = day of first therapeutic intervention) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Micro level 1.1 Quantitative Evaluation: Secondary Outcomes I: Clinical data of patients cared for at MTB (event-driven, based on quantitative questionnaire completed by site staff). - Response - Progression-free survival - Overall survival - Toxicities Secondary Outcomes II: Patient satisfaction and quality of life of patients receiving care at MTB (at study inclusion, 2-3 months after study inclusion & 5-6 months after study inclusion). - Satisfaction (modified questionnaire instrument based on SCCG instrument). - Quality of life (established disease-related quality of life questionnaire instruments EQ5D-5L and EORTC QLQ C30). Secondary outcomes III: Health economics - Utilization of health care services (modified questionnaire instrument based on the FIMA questionnaire). - Change in health care expenditures of patients served in MTB (quanitative patient questionnaire) 1.2 Qualitative evaluation: Patient level survey (at different points of the project, interviews with patients): - Understanding and attitude towards personalized medicine - Qualitative evaluation of the implementation processes - Expectations of the care provided by the ZPMs/the DNPM - Perceived care before or with ZPMs/DNPMs - Costs incurred in the context of PM care 2) Meso level Survey at center and network level or from staff perspective of ZPMs and the DNPM (at different points of the project, quantitative questionnaire, focus groups and protocol reviews): - Attitudes toward and experiences with personalized medicine. - Attitudes towards or experiences with the change processes - Satisfaction of the staff involved - Planning and adaptations in the implementation process - Possible hurdles and support factors in the implementation process - Perceived added value of the new form of care - Degree of standardization of processes - Degree of establishment of new coordination processes at the medical or specialist level (e.g., expert committees) - Implementatio | — |
Countries
Germany
Outcome results
None listed