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Recruiting NCT07505498

Screening for Supportive Care Needs of Oncological Patients and Professionals - Evaluation of a Short PRO-question Set

Observational Patient Related Outcome Measures Supportive Care Patient Reported Outcome (PRO)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Patient Related Outcome Measures, Supportive Care, Patient Reported Outcome (PRO). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Germany
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Scope-PRO: Screening for Supportive Care Needs of Oncological Patients and Professionals - Evaluation of a Short PRO-question Set

Overview

The systematic recording of patient-reported symptoms and health-related quality of life (patient-reported outcomes, PROs) is a central component of oncological care. Currently, however, screening for support needs in German hospitals is inconsistent and uses different assessment tools, leading to heterogeneity, redundant surveys, and limited comparability of results. This complicates standardized, patient-centered, and cross-sector care, as well as the early identification of therapy-associated side effects and support needs. The aim of the study is to investigate the acceptance and relevance of the core set of questions from the perspective of both cancer patients and professional healthcare providers. Cancer patient acceptance will be measured by the proportion of fully completed questionnaires, while cancer patient relevance will be assessed using a feedback form. The professional perspective will be gathered through guided feedback in quality circles conducted regularly in accordance with internal standards

Primary outcome measures

  • Proportion of Participants with Complete Core Question Set Completion at Baseline [Time frame: Baseline]
  • Participant-Reported Acceptance Score (Study-Specific Acceptance Feedback Questionnaire) at Baseline [Time frame: Baseline]
Secondary outcome measures (8)
  • Participant-Reported Relevance Score of the Core Question Set [Time frame: Baseline]
  • Centre-Level Characteristics and Implementation Practices of PROM-Based Supportive Care Screening [Time frame: Baseline and last-patient-in at the respective institution]
  • Severity of Prespecified Symptoms (Scope-PRO Core Question Set) [Time frame: Baseline]
  • Psychological Distress Score (Scope-PRO Core Question Set) [Time frame: Baseline]
  • Global Quality of Life Score (Scope-PRO Core Question Set) [Time frame: Baseline]
  • Proportion of Participants Reporting Specific Supportive Care Needs at Baseline (Scope-PRO Core Question Set) [Time frame: Baseline]
  • Performance Status Score (Scope-PRO Core Question Set) [Time frame: Baseline]
  • Nutritional Risk Score (Scope-PRO Core Question Set) [Time frame: Baseline]

Eligibility criteria

Inclusion criteria

  • Age ≥ 18 years
  • Capacity to give consent
  • Cancer patients
  • Sufficient understanding of the German language

Exclusion criteria

  • Minors
  • Lack of capacity to give consent
  • Insufficient knowledge of German

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Germany · 1 center
  • University Medical Center Göttingen, Department of Gastroenterology, gastrointestinal onco — Göttingen

Identifiers

NCT: NCT07505498 · 2025-03979

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗