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

University Medical Center Goettingen900 enrolled

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

Study Type

OBSERVATIONAL

Enrollment

900

Conditions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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 (%)

Time frame: 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.

Time frame: Baseline

Secondary Outcomes

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.

Time frame: 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 \[%\])

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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 (%)

Time frame: 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.

Time frame: 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.

Time frame: Baseline

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

Overview

Conditions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts