Patient Related Outcome Measures, Patient Reported Outcome (PRO), Supportive Care
Conditions
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
Interventions
None listed
Sponsors
University Medical Center Goettingen
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Participants with Complete Core Question Set Completion at Baseline | 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 (%) |
| Participant-Reported Acceptance Score (Study-Specific Acceptance Feedback Questionnaire) at Baseline | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Participant-Reported Relevance Score of the Core Question Set | 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. |
| Centre-Level Characteristics and Implementation Practices of PROM-Based Supportive Care Screening | 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 \[%\]) |
| Severity of Prespecified Symptoms (Scope-PRO Core Question Set) | 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. |
| Psychological Distress Score (Scope-PRO Core Question Set) | Baseline | Psychological distress is assessed using the Distress Thermometer. Scale Distress Thermometer Range: 0 to 10 Higher scores indicate greater psychological distress. |
| Global Quality of Life Score (Scope-PRO Core Question Set) | Baseline | Global Quality of Life Score Scale 7-point scale Range: 1 (very poor) to 7 (excellent) Higher scores indicate better quality of life. |
| Proportion of Participants Reporting Specific Supportive Care Needs at Baseline (Scope-PRO Core Question Set) | 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 (%) |
| Performance Status Score (Scope-PRO Core Question Set) | 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. |
| Nutritional Risk Score (Scope-PRO Core Question Set) | 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. |
Countries
Germany
Contacts
CONTACTSabrina Dr. Sulzer
Outcome results
None listed