University Medical Center Göttingen, Department of Gastroenterology, gastrointestinal oncology and endocrinology
Göttingen, 37075, Germany
Location status: Recruiting
NCT Number: NCT07505498
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
Interested in participating?
Request Info18 year and older
All sexes
Observational
Göttingen, 37075, Germany
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 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 (%)
Time frame: 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.
Time frame: Baseline
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.
Time frame: Baseline and last-patient-in at the respective institution
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 [%])
Time frame: Baseline
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.
Time frame: Baseline
Psychological distress is assessed using the Distress Thermometer. Scale Distress Thermometer Range: 0 to 10 Higher scores indicate greater psychological distress.
Time frame: Baseline
Global Quality of Life Score Scale 7-point scale Range: 1 (very poor) to 7 (excellent) Higher scores indicate better quality of life.
Time frame: Baseline
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 (%)
Time frame: Baseline
Performance status is assessed using the patient-reported ECOG scale. Scale ECOG Performance Status Range: 0 to 4 Higher scores indicate worse functional status.
Time frame: Baseline
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.
Contact information is provided by the study sponsor or research team.
University Medical Center Goettingen
Other
Scope-PRO: Screening for Supportive Care Needs of Oncological Patients and Professionals - Evaluation of a Short PRO-question Set
Acronym: Scope-PRO
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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