C64-C68 C61
Conditions
Interventions
Group 1: Patients in the observation phase:
Each patient is observed for a total period of 3 months. The exact intervals within these 3 months depend on the individual treatment regimen and can gener
Sponsors
Promotionsprogramm Klinische Pharmazie LMU Klinikum
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Uro-oncological disease: renal cell carcinoma, urinary bladder carcinoma or prostate carcinoma; stage of uro-oncological disease: all stages; new initiation or change of therapy (change of regimen, change of individual drugs in the regimen) during ongoing therapy with intravenously administered or peroral tumor therapeutics, within one month after initiation or change of therapy; sufficient knowledge of the German language, spoken and written, to understand study documents and information materials and to communicate adequately when taking a drug history.
Exclusion criteria
Exclusion criteria: Age younger than 18 years; Insufficient knowledge of the German language; Pathophysiological cognitive impairments that severely impair memory performance; Pregnancy and lactation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Unresolved drug-related problems (first primary outcome): Recording the medication history by performing a complete medication review (medication data, clinical data, patient interview). In the observation phase, the medication review is carried out once at the end of the three-month observation period and the unresolved drug-related problems are recorded in this way. In the intervention phase, the data is recorded continuously at each care point, meaning every 4 weeks +/- 1 week over the entire three-month period. The medication history in the intervention phase is taken with the assistance of a validated, German-language PRO-CTCAE questionnaire (31 items, Patient-Reported Outcomes - Common Terminology Criteria for Adverse Events, Ref: National Cancer Institute, https://healthcaredelivery.cancer.gov/pro-ctcae/). Patient satisfaction with the information on tumor treatment (second primary outcome): Assessment using the validated, German-language PS-CaTE questionnaire (16 items, Patient Satisfaction with Cancer Treatment Education, Ref: Liekweg et al. Pharm World Sci 2005), "global satisfaction" scale. The survey times are identical in the observation and intervention phases and are carried out once at the second care point, meaning 4 weeks +/- 1 week after the start of observation / care, and then again at the end of the three-month observation / care period. Process evaluation feasibility and acceptance: Both aspects are assessed after implementation of the complex intervention in the intervention phase. The following calculations are made for feasibility: Number of medication reconciliations performed/number of medication reconciliations required during the intervention phase; number of patient information dispensed/number of patient information required during the intervention phase. In addition, the duration of the medication reconciliations and factors influencing its duration were examined. Acceptance with regard to the two intervention components, medica | — |
Secondary
| Measure | Time frame |
|---|---|
| Health-related quality of life: Assessment using the validated EORTC QLQ-C30 questionnaire, version 3 (30 items, European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire, Core Module 30, Ref: https://qol.eortc.org/questionnaires/core/eortc-qlq-c30/). The survey is conducted at each observation/care point in both the observation and intervention phases. Unresolved drug-related problems by category: The general survey of unresolved drug-related problems (DRP) is already carried out as a primary endpoint. The DRP can be further subdivided according to the PCNE classification (Pharmaceutical Care Network Europe, Ref: https://www.pcne.org/working-groups/2/drug-related-problem-classification). These subgroups will be analyzed as a secondary endpoint. Patient satisfaction subscales: The general survey of patient satisfaction (global satisfaction) is already carried out as a primary endpoint. The PS-CaTE questionnaire used can be divided into different subscales (satisfaction with information on cancer treatment, satisfaction with information on adverse drug reactions, satisfaction with information on vitamins, herbal medicines and complementary therapy options, satisfaction with sources of information (personal/material)), which are also to be analyzed. Adherence: Assessment using the MARS-5 questionnaire planned (5 items, Medication Adherence Report Scale, Ref: Mahler C et al. J Eval Clin Pract 2010) for patients with oral tumor therapy exclusively in the intervention phase. The questionnaire is collected once at the beginning and once at the end of the three-month treatment period. Therapy discontinuations/postponements/dose adjustments: Collected during the entire observation and intervention phase from the digital medical record. Documented drugs: Data is collected during the entire observation and intervention phase on the basis of the digital medical record and the medication analyses carried out. | — |
Countries
Germany
Contacts
Public ContactMaximilian Günther
Promotionsprogramm Klinische Pharmazie LMU Klinikum
Outcome results
None listed