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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Medical Center Goettingen

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years

Capacity to give consent

Cancer patients

Sufficient understanding of the German language

Disqualifiers

Minors

Lack of capacity to give consent

Insufficient knowledge of German

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

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
2

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

1

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
2

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
3

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
4

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

Other outcomes

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