Optimization of polypharmacy in geriatric oncology

Optimization of polypharmacy in geriatric oncology - OPTIMAL

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00031024

Enrollment

514

Registered

2023-02-13

Start date

2023-06-05

Completion date

Unknown

Last updated

2026-02-02

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

Conditions

C15-C26 C50 C51-C58 C81-C96 C33 C34 C43 C61 C64 C67

Interventions

Group 1: Comprehensive medication review with the 4th edition of the FORTA list of 2021 Group 2: Usual care

Eligibility

Sex/Gender

All

Age

65 Years to No maximum

Inclusion criteria

Inclusion criteria: • Diagnosis or recurrence requiring treatment of one of 22 frequent cancers (see chapter „Health condition“ for complete list) in last 5 years • Exposure to polypharmacy, defined as = 5 chronically, concurrently used active substances • At least 3 weeks of in-patient rehabilitation in a cooperating clinic are planned • Sufficient capabilities for informed consent

Exclusion criteria

Exclusion criteria: • No written informed consent to participate • No sufficient mental and physical capabilities to fill self-administered questionnaires. • No sufficient knowledge of the German language. • Missing information needed to conduct the medication review with the FORTA list • No medication related problem at baseline (FORTA score = 0). • Missing baseline information needed for the primary endpoint (global quality of life).

Design outcomes

Primary

Measure	Time frame
Change in global quality of life (assessed by the European Organisation for Research and Treatment of Cancer’s Quality of Life Questionnaire’s Core 30 items (EORTC QLQ-C30) global health status (GHS)/quality of life score) from start of in-patient rehabilitation to 8-month follow-up	—

Secondary

Measure	Time frame
• Medication quality (Total FORTA score and sub-scores for medication underuse, medication overuse and potentially inappropriate medication use) • Global, domain-specific and symptom-related quality of life (All EORTC QLQ-C30 scores) • Fatigue (Physical, emotional and cognitive fatigue as well as interference of fatigue with daily life (assessed with the EORTC Fatigue Questionnaire with 12 items (EORTC-FA12)) • Frailty (assessed by FRAIL-Scale) • Dizziness (self-developed question) • Falls (self-developed question) • Hospitalizations (self-developed question) • Cancer mortality (ICD-10 code C00-C97), non-cancer mortality and all-cause mortality (assessed by register matching for up to 10 years)	—

Measure

Time frame

• Medication quality (Total FORTA score and sub-scores for medication underuse, medication overuse and potentially inappropriate medication use) • Global, domain-specific and symptom-related quality of life (All EORTC QLQ-C30 scores) • Fatigue (Physical, emotional and cognitive fatigue as well as interference of fatigue with daily life (assessed with the EORTC Fatigue Questionnaire with 12 items (EORTC-FA12)) • Frailty (assessed by FRAIL-Scale) • Dizziness (self-developed question) • Falls (self-developed question) • Hospitalizations (self-developed question) • Cancer mortality (ICD-10 code C00-C97), non-cancer mortality and all-cause mortality (assessed by register matching for up to 10 years)

—

Countries

Germany

Contacts

Public ContactBen Schöttker

Deutsches Krebsforschungszentrum

b.schoettker@dkfz.de+49 6221 42 1355

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 9, 2026