Building a nationwide safety net for oral antitumor therapy: SafetyFIRST – a cluster-randomized stepped-wedge trial

Not Applicable

Recruiting

• Conditions: C00-D48; Neoplasms

• Registration Number: DRKS00032764
• Lead Sponsor: Apotheke des Uniklinikums Erlangen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-11-16
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 600

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

- 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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Combined endpoint of severe side effects (CTCAE =3), treatment discontinuation, unscheduled hospital admission, and all-cause mortality between week 0 and week 12