Clinical studies in pediatric oncology should better adress the needs of patients and families by implementing a mobile trial team. C00-D48
Conditions
Interventions
Group 1: Patients with home visits
For these patients as many study or regular treatment visits are performed at the patients home
At all visits (but not more frequent than every 4 weeks) the followi
Sponsors
Hopp-Kindertumorzentrum Heidelberg
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Oncological disease - Treatment at the Hopp Children's Cancer Center (KiTZ) Heidelberg as part of a clinical trial (phase I/II/III) or guideline-based therapy with observation as part of a registry - Treatment protocol classified as compatible with MTT participation (see below) - Place of residence accessible by car within approximately 1 hour of KiTZ Heidelberg - Written consent form from patients/parents
Exclusion criteria
Exclusion criteria: 1) Before the first home visit is carried out, a home visit with a “safety and feasibility check” is carried out. For this purpose, the local conditions of the place of residence are recorded in a standardized manner in order to determine whether the planned treatment can be carried out safely. If the safety and feasibility check is not passed, the patient is excluded from the study. The following are necessary for a positive safety and feasibility check: - A quiet place for patient treatment (e.g., own room) - Adequate hygienic conditions - Accessibility within approximately 1 hour's drive by car from KiTZ Heidelberg - Adequate network reception for telephone communication with KiTZ 2) During one of the first 3 visits to the hospital, an unexpected complication arises that changes the risk assessment of the procedure to be performed. 3) Insufficient compliance with repeated absence of the patient when the mobile team arrives 4) Withdrawal of consent by the study participant or legal guardian
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of hospital visits that are replaced by home visits. Respective numbers are determined every 6 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Time spent at the hospital (including waiting), duration of travel, travel distance, time spent at school/kindergarten, social contacts (friends/family); data collected with specifically designed questionnaire (logistics) during every visit (but not more often than every 4 weeks) 2) working time /resources per patient; data collected with specifically designed questionnaire (logistics) during every visit 3) completeness/quality of collected data; determination after every visit 4) number of severe adverse events/unscheduled hospital visits; data collected at the end of care by mobile team 5) Quality of life (patients and families) [questionnaires: PedsQL_4.0-Core-All_AU4.0_deu-DE, PedsQL-3.0-Cancer-All_AU3.0_deu-DE, PedsQL_2.0-FIM-All_AU2.0_deu-DE] at all visits (but not more frequent than every 4 weeks) 6) Depression and anxiety in parents [questionnaires PHQ-9 (Brief Patient Health Questionnaire), GAD-7 [Generalizied Anxiety Disorder Scale-7 (GAD-7)] at all visits (but not more frequent than every 4 weeks) 7) Biological stress response to visits (cortisol levels in saliva during three home visits and three hospital visits) | — |
Countries
Germany
Contacts
Public ContactJonas Ecker
Hopp-Kindertumorzentrum Heidelberg
Outcome results
None listed