Development and validation of a PRO-CTCAE questionnaire for patients receiving oral antitumor therapy

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00035535

Enrollment

300

Registered

2024-11-18

Start date

2024-12-01

Completion date

Unknown

Last updated

2026-08-03

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

Conditions

C00-D48

Interventions

Group 1: Patients with oral antitumor therapy are asked once about their symptoms and quality of life

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: - Treatment with a newer oral antitumor agent (approval from February 2, 2001 = date the approval was granted for capecitabine by the European Medicines Agency EMA) or temozolomide (granted approval before capecitabine, but inclusion due to high clinical relevance) - Ability to fill out questionnaires independently - Tumor diagnosis/stage: no limitation - Outpatient or inpatient treatment

Exclusion criteria

Exclusion criteria: - Lack of German language skills (written skills and understanding spoken German) - Pathological cognitive impairments (e.g. neurodegenerative diseases that severely affect the patient's memory) - Patients unable to consent - Pregnant/breastfeeding patients - Previous participation in the PROC-OAT study

Design outcomes

Primary

Measure	Time frame
Validity (principal component analysis with varimax rotation, multitrait-multimethod matrix), after end of study, statistical analysis	—

Secondary

Measure	Time frame
Reliability (Cronbach's alpha), after end of study, statistical analysis	—

Countries

Germany

Contacts

Public ContactLars Wismar

Pharmazeutisches Institut

l.wismar@uni-bonn.de+49228-73-5781

Outcome results

None listed

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