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

NCT07505498 | Recruiting

• 1 other identifier: 2025-03979
• Study Type: observational
• Target: 900
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (8)

• Participant-Reported Relevance Score of the Core Question Set

  Baseline

• Centre-Level Characteristics and Implementation Practices of PROM-Based Supportive Care Screening

  Baseline and last-patient-in at the respective institution

• Severity of Prespecified Symptoms (Scope-PRO Core Question Set)

  Baseline

• Psychological Distress Score (Scope-PRO Core Question Set)

  Baseline

• Global Quality of Life Score (Scope-PRO Core Question Set)

  Baseline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University Medical Center Goettingen: lead

Study Sites (1)

University Medical Center Göttingen, Department of Gastroenterology, gastrointestinal oncology and endocrinology

Göttingen, 37075, Germany

RECRUITING

Central Study Contacts

Sabrina Dr. Sulzer

CONTACT

0551 39 62313; sabrina.sulzer@med.uni-goettingen.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident Physician

Study Record Dates

• First Submitted: November 18, 2025
• First Posted: April 1, 2026
• Study Start: December 1, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: April 1, 2026

Record last verified: 2026-03

Locations

DE (1)