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NCT Number: NCT07505498

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

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

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Göttingen, 37075, Germany

Location status: Recruiting

Location contact

Sabrina Sulzer, MHBA, Dr.

CONTACT

[email protected]

0551-39-62313

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Proportion of Participants with Complete Core Question Set Completion at Baseline

    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 (%)

  2. Participant-Reported Acceptance Score (Study-Specific Acceptance Feedback Questionnaire) at Baseline

    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.

Secondary outcomes

  1. Participant-Reported Relevance Score of the Core Question Set

    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.

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

    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 [%])

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

    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.

  4. Psychological Distress Score (Scope-PRO Core Question Set)

    Time frame: Baseline

    Psychological distress is assessed using the Distress Thermometer. Scale Distress Thermometer Range: 0 to 10 Higher scores indicate greater psychological distress.

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

    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.

  6. Proportion of Participants Reporting Specific Supportive Care Needs at Baseline (Scope-PRO Core Question Set)

    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 (%)

  7. Performance Status Score (Scope-PRO Core Question Set)

    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.

  8. Nutritional Risk Score (Scope-PRO Core Question Set)

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Sabrina Dr. Sulzer

CONTACT

[email protected]

0551 39 62313

Sponsors and collaborators

Lead sponsor

University Medical Center Goettingen

Other

Registry information

Official study title

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

Acronym: Scope-PRO

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Apr 1, 2026
Registry last updated
Apr 1, 2026

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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