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Medication safety in patients treated with new oral anticancer agents: a prospective randomized investigation on the impact of intensified clinical pharmaceutical/clinical pharmacological care on patient safety and patient reported outcome

Medication safety in patients treated with new oral anticancer agents: a prospective randomized investigation on the impact of intensified clinical pharmaceutical/clinical pharmacological care on patient safety and patient reported outcome - AMBORA

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00013271
Enrollment
300
Registered
2017-11-03
Start date
2017-11-16
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

all types of cancer treated with an oral anticancer agent

Interventions

Group 1: Control group: standard therapy (patient care according to the standard of care
education and information about newly prescribed oral anticancer drug by prescribing physician, no additional advice from pharmacists / pharmacologists) Group 2: Intervention group: intensive clinical

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 anticancer agent, cancer diagnosis, adult patient, planned duration of therapy / estimated lifespan of at least 4 months, ability to complete questionnaires

Exclusion criteria

Exclusion criteria: Prolonged inpatient stay and concomitant i.v. chemotherapy with classical cytostatic drugs, lack of german language skills, cognitive impairment, non-consenting patients, patients who are not able to take their medicine on their own, pregnant / lactating women, missing written consent

Design outcomes

Secondary

MeasureTime frame
patient knowledge (SIMS-D questionnaire after 12 weeks), adherence (MARS-D questionnaire after 12 weeks), quality of life (QLQ-C30 questionnaire after 12 weeks)

Primary

MeasureTime frame
drug related problems (DRP) (number of DRP per patient after 12 weeks), satisfaction with anticancer therapy (TSQM VII questionnaire after 12 weeks)

Countries

Germany

Contacts

Public ContactPauline Dürr

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

pauline.duerr@uk-erlangen.de+49(0)91318521128

Outcome results

None listed

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