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

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

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

Study Overview

• Status: Recruiting
• Conditions: Supportive Care; Patient Related Outcome Measures; Patient Reported Outcome (PRO)

• Study Type: Observational
• Enrollment (Estimated): 900

Contacts and Locations

• Study Contact: Name: Sabrina Dr. Sulzer; Phone Number: 0551 39 62313; Email: sabrina.sulzer@med.uni-goettingen.de

Study Locations

• Germany
  • Göttingen, Germany, 37075
    • Recruiting
    • University Medical Center Göttingen, Department of Gastroenterology, gastrointestinal oncology and endocrinology
    • Contact: Sabrina Sulzer, MHBA, Dr.; Phone Number: 0551-39-62313; Email: sabrina.sulzer@med.uni-goettingen.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

The study is intended for oncology patients before/during/after treatment in DKG-certified oncology centers and organ centers, as well as oncology practices cooperating with a DKG-certified organ or oncology center.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of Participants with Complete Core Question Set Completion at Baseline	Description Acceptance is operationalised as the proportion of enrolled cancer patients who fully complete the predefined Scope-PRO core question set at baseline. Questionnaire completeness is used as an indirect indicator of acceptability. Unit of Measure Proportion (%)	Baseline
Participant-Reported Acceptance Score (Study-Specific Acceptance Feedback Questionnaire) at Baseline	Participant-reported acceptance is assessed using a study-specific feedback questionnaire evaluating comprehensibility, perceived burden, and overall acceptability of the core question set. Scale Study-specific Acceptance Feedback Questionnaire Range: 1 to 4 Higher scores indicate higher acceptance.	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participant-Reported Relevance Score of the Core Question Set	Perceived relevance of the core question set is assessed using a predefined relevance item included in the study-specific acceptance feedback questionnaire. Scale: Study-specific Relevance Feedback Item Range: 1 to 4 Higher scores indicate higher perceived relevance.	Baseline
Centre-Level Characteristics and Implementation Practices of PROM-Based Supportive Care Screening	Centre-level characteristics and implementation practices of PROM-based supportive care screening are assessed using a structured, study-specific centre questionnaire. Predefined domains include centre characteristics, existing supportive care screening procedures, screening thresholds, implementation processes following positive screening, and required personnel and time resources. Data will be reported descriptively at the centre level. Unit of Measure Descriptive measures (e.g., counts, proportions [%])	Baseline and last-patient-in at the respective institution
Severity of Prespecified Symptoms (Scope-PRO Core Question Set)	Description Symptom severity is assessed for prespecified individual symptoms included in the Scope-PRO core question set. 4-point Likert scale (none, mild, moderate, severe) Range: 1 to 4 Higher scores indicate greater symptom burden.	Baseline
Psychological Distress Score (Scope-PRO Core Question Set)	Psychological distress is assessed using the Distress Thermometer. Scale Distress Thermometer Range: 0 to 10 Higher scores indicate greater psychological distress.	Baseline
Global Quality of Life Score (Scope-PRO Core Question Set)	Global Quality of Life Score Scale 7-point scale Range: 1 (very poor) to 7 (excellent) Higher scores indicate better quality of life.	Baseline
Proportion of Participants Reporting Specific Supportive Care Needs at Baseline (Scope-PRO Core Question Set)	Supportive care needs are assessed using multiple binary (yes/no) items within the Scope-PRO core question set. Each supportive care need is analysed separately and reported as the proportion of participants indicating the respective need. Unit of Measure Proportion (%)	Baseline
Performance Status Score (Scope-PRO Core Question Set)	Performance status is assessed using the patient-reported ECOG scale. Scale ECOG Performance Status Range: 0 to 4 Higher scores indicate worse functional status.	Baseline
Nutritional Risk Score (Scope-PRO Core Question Set)	Nutritional risk is assessed using the Nutritional Risk Screening 2002 (NRS 2002) Scale Nutritional Risk Screening 2002 (NRS 2002) Range: 0 to 7 Higher scores indicate greater nutritional risk.	Baseline

Collaborators and Investigators

• Sponsor: University Medical Center Goettingen

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: November 18, 2025
• First Submitted That Met QC Criteria: March 29, 2026
• First Posted (Actual): April 1, 2026

Study Record Updates

• Last Update Posted (Actual): April 1, 2026
• Last Update Submitted That Met QC Criteria: March 29, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 2025-03979

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No