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Reliability tEstinG of diGital pAtient-reported-experience mEasures (PREMs) - the randomized controlled REGGAE trial

Reliability tEstinG of diGital pAtient-reported-experience mEasures (PREMs) - the randomized controlled REGGAE trial - REGGAE

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00029405
Enrollment
132
Registered
2022-12-09
Start date
2022-12-22
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

suspected or histologically proven oncological disease C15 C16 C18 C19 C26

Interventions

Group 1: First data entry: digital PREMs, Quality of Life Questionnaire Second data entry: paper based PREMs, Quality of Life Questionnaire Group 2: First data entry: paper based PREMs, Quality of Lif

Sponsors

Universitäsklinikum Ulm
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: - Age = 18 years - Written informed consent - Planned or completed surgery for suspected or histologically verified oncological disease - Sufficient knowledge of the German language - Equipment and ability to fill in questionnaires digitally - Ability of subject to understand character and individual consequences of the clinical trial

Exclusion criteria

Exclusion criteria: - Patients with incipient or progressive dementia - Participation in another trial with interference of the primary endpoint of this study

Design outcomes

Primary

MeasureTime frame
Reliability between digital and paper-based PREM measured by correlation between digital and paper-based responses of the two following PREMs: “Patient Satisfaction with Cancer-related Care – German version” (PSCC-G, Bokemeyer 2020) and “Patients’ Experiences Across Health Care Sectors” (PEACS, Noest 2014) questionnaire

Secondary

MeasureTime frame
1.) Feasibility of digital PREM assessment 2.) Assessment of patient-centredness via the PSCC-G (and PEACS)

Countries

Germany

Contacts

Public ContactAndré Mihaljevic

Klinik für Allgemein- und ViszeralchirurgieUniversitätsklinik Ulm

andre.mihaljevic@uniklinik-ulm.de+49 731 500 53502

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026