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Optimizing medication safety in patients with oral antitumor therapy through intensified clinical tele-pharmaceutical/pharmacological care: A randomized non-inferiority study

Optimizing medication safety in patients with oral antitumor therapy through intensified clinical tele-pharmaceutical/pharmacological care: A randomized non-inferiority study - AMBORA-Tele+

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00034944
Enrollment
300
Registered
2024-09-04
Start date
2024-10-15
Completion date
Unknown
Last updated
2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

all tumor entities treated with an oral antitumor drug C00-D48

Interventions

Group 1: Control Group: Intensified clinical-pharmaceutical/pharmacological care primarly via consultations on-site The clinical-pharmaceutical/pharmacological care includes medication management, sid

Sponsors

Apotheke des Universitätsklinikums Erlangen; Lehrstuhl für Klinische Pharmakologie und Klinische Toxikologie der FAU Erlangen-Nürnberg
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Initiation of therapy with an oral antitumor drug, cancer diagnosis, adult patient, planned therapy duration/estimated lifespan of at least 4 months, ability to independently complete questionnaires, technical requirements: internet, camera, microphone, and speakers on the device used for videocalls.

Exclusion criteria

Exclusion criteria: Lack of german language skills, patients unable to give consent, cognitive impairments that prevent adequate study participation, missing written consent, patients who are not able to take their medicine on their own, pregnant/breastfeeding patients.

Design outcomes

Primary

MeasureTime frame
drug-related problems (DRP; side effects and unresolved medication errors) related to oral antitumor therapy within 12 weeks, patient satisfaction with therapy (TSQM Ver. II Questionnaire) after 12 weeks.

Secondary

MeasureTime frame
quality of life (EQ-5D-5L Questionnaire), severe side effects (CTCAE = Grade 3) related to overall medication, overall survival, combined endpoint of severe side effects (CTCAE =3), treatment discontinuation, unscheduled hospital admission, and all-cause mortality between week 0 and week 12

Countries

Germany

Contacts

Public ContactAMBORA-Team

Apotheke des Universitätsklinikums Erlangen; Lehrstuhl für Klinische Pharmakologie und Klinische Toxikologie der FAU Erlangen-Nürnberg

ambora.ap@uk-erlangen.de+49 9131 85 32542

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Jun 11, 2026