C00-D48
Conditions
Interventions
Group 1: Control group: For patients recruited during the control phase, the standard clinical routine at the facilities remains unaffected. Contacts at the defined time points are solely for the purp
Sponsors
Apotheke des Uniklinikums Erlangen
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Therapy initiation at one of the participating local sites with: - A newer oral anti-tumor agent (substance authorized for use after February 2, 2001 = date of authorization for Capecitabine by the European Medicines Agency EMA), or - Temozolomide (inclusion due to high clinical relevance despite approval before the approval date for Capecitabine). - Planned duration of therapy: at least 4 months - Estimated life expectancy: at least 4 months - Ability to independently fill out questionnaires - Tumor diagnosis / stages: no limitations - Treatment setting: outpatient (or inpatient) treatment setting, outpatient follow-up care
Exclusion criteria
Exclusion criteria: - Absence of sufficient German language skills (ability to understand written and spoken German) - Pathological cognitive deficiencies (e.g., neurodegenerative diseases severely affecting patients' memory) - Non-capable-of-consent patients - Patients unable to take their medication independently - Pregnant / breastfeeding patients - Absence of written consent statement
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Combined endpoint of severe side effects (CTCAE =3), treatment discontinuation, unscheduled hospital admission, and all-cause mortality between week 0 and week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| - Percentage of patients with at least one severe symptomatic toxicity, measured using the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE), = Grade 3 between week 0 and week 12. - Number of unresolved medication errors per patient related to oral antitumor therapy after week 12. - Duration of treatment, measured as the time interval between the initial prescription and discontinuation of oral antitumor therapy within the observation period. - Patient well-being and satisfaction with oral antitumor therapy, assessed using the Treatment Satisfaction Questionnaire for Medication (TSQM Ver. II), "Convenience" category after 12 weeks. - Adherence to oral antitumor therapy, measured using the Medication Adherence Report Scale (MARS-D) after 12 weeks. - Quality of life, assessed using the European Quality of Life 5 Dimensions 5 Level Questionnaire (EQ-5D-5L) after 12 weeks. All secondary study objectives pertain to the comparison between the control and intervention groups. | — |
Countries
Germany
Contacts
Public ContactUlrich Jaehde
Pharmazeutisches Institut, Rheinische Friedrich-Wilhelms-Universität Bonn
Outcome results
None listed