ICD-10-GM C00 - C75 - malignant neoplasms, with the exception of C50 - C68
Conditions
Interventions
Group 1: Patients in the observation phase, 9 months:
Patients are observed over a period of three months. Initially, baseline values for the endpoints are recorded. At each appointment at the oncolo
Sponsors
Promotionsprogramm Klinische Pharmazie LMU Klinikum
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Start of a tumor therapy, intravenous therapy, written medication plan
Exclusion criteria
Exclusion criteria: Gynecological or urological tumor disease; hematological malignant disease; insufficient knowledge of the German language; pathophysiological cognitive impairments that severely affect memory performance; pregnancy and breastfeeding; Treatment with a drug for the tumor disease that was approved in Germany or the EU after recruitment for the study began.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| First primary endpoint: Number of supportive measures performed adherent to guidelines. For each patient case, the measures indicated according to the S3 guideline “Supportive Therapie onkologischer PatientInnen” are recorded, as well as which measures are ordered, implemented, and, if applicable, included in the physician's letter and thus performed guideline-adherent. Second primary endpoint: Symptom burden The symptom burden of patients is continuously recorded using the German, validated PRO-CTCAE core item set (31 items; Patient-Reported Outcomes – Common Terminology Criteria for Adverse Events, National Cancer Institute, https://healthcaredelivery.cancer.gov/pro-ctcae/). Data are collected at the observation points baseline, month 1, month 2, and month 3, both overall and according to categories of supportive measures. Symptomatic toxicities are recorded, defined as baseline-adjusted PRO-CTCAE grade 3. Process evaluation - Acceptance and feasibility of the pharmaceutical intervention: The process evaluation takes place exclusively in the intervention phase after implementation of the complex pharmaceutical intervention. The acceptance of the pharmaceutical intervention is assessed through semi-structured interviews with patients and physicians. Feasibility is evaluated as the proportion of measures carried out in relation to the measures required. In addition, the duration of interventions is recorded. Factors influencing this duration are recorded and evaluated. | — |
Secondary
| Measure | Time frame |
|---|---|
| Guideline adherence by guideline subcategories: Recorded in the same manner as on the aggregated level for supportive measures per category of the S3 guideline. Medication errors: Medication errors are classified and documented according to NCC MERP classification (National Coordinating Council for Medication Error Reporting and Prevention, Ref: https://www.nccmerp.org/types-medication-errors) while the underlying drug-related problems (DRP) are classified and documented according to PCNE classification (Pharmaceutical Care Network Europe, Ref: https://www.pcne.org/working-groups/2/drug-related-problem-classification). The number of supportive measures performed correctly (without medication errors) is recorded per patient case. Differences in the number of medication errors and DRPs between the observation and intervention phases are evaluated. According to the PCNE classification, DRPs can be divided into subgroups. An analysis of these subgroups is also carried out. Adherence: The MARS-5 questionnaire (5 items, Medication Adherence Report Scale, Ref: Mahler C et al. J Eval Clin Pract 2010) is used to assess patient adherence. The questionnaire should be completed by patients on a monthly basis. The evaluation takes place at baseline, month 1, month 2, and month 3. Therapy discontinuations, postponements, dose adjustments: Survey during the observation and intervention phase based on the electronic patient record. Hospitalizations, weight loss: Survey during the observation and intervention phase based on the electronic patient record. Number of documented medications: Survey during the observation and intervention phase based on the electronic patient record. | — |
Countries
Germany
Contacts
Public ContactMaximilian Günther
Promotionsprogramm Klinische Pharmazie LMU Klinikum
Outcome results
None listed