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

Not Applicable

Recruiting

• Conditions: suspected or histologically proven oncological disease; C15; C16; C18; C19; C26; Malignant neoplasm of oesophagus; Malignant neoplasm of stomach; Malignant neoplasm of colon; Malignant neoplasm of rectosigmoid junction

• Registration Number: DRKS00029405
• Lead Sponsor: niversitäsklinikum Ulm

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-12-09
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 132

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

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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
1.) Feasibility of digital PREM assessment<br>2.) Assessment of patient-centredness via the PSCC-G (and PEACS)