Patient Related Outcome MeasuresScope-PRONCT07505498
Screening for Supportive Care Needs of Oncological Patients and Professionals - Evaluation of a Short PRO-question Set
An observational study of Patient Related Outcome Measures and Supportive Care, run by University Medical Center Goettingen at 1 site in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patient Related Outcome Measures, Supportive Care, Patient Reported Outcome (PRO)
- How many people
- 900 participants
- Where
- 1 siteGermany
- Study dates
- 1 Dec 2025to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study 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.
Who may be able to join
- Age ≥ 18 years
- Capacity to give consent
- Cancer patients
- Sufficient understanding of the German language
Who cannot join
- Minors
- Lack of capacity to give consent
- Insufficient knowledge of German
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
University Medical Center Göttingen, Department of Gastroenterology, gastrointestinal oncology and endocrinology
Göttingen, 37075
Sabrina Sulzer, MHBA, Dr., 0551-39-62313, sabrina.sulzer@med.uni-goettingen.de
About this study
Official title: Scope-PRO: 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
What is being measured
The primary outcome is the main question the study is designed to answer.
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 (%)
Measured: 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.
Measured: Baseline
Secondary outcomes (8)
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.
Measured: 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 [%])
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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 (%)
Measured: 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.
Measured: 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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2026
- Study start1 Dec 2025
- Primary completion1 Jan 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patient Related Outcome MeasuresStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 900 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Center Goettingen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sabrina Sulzer, University Medical Center Goettingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07505498
- Sponsor's protocol ID
- 2025-03979
- Other IDs
- 2025
- Acronym
- Scope-PRO
- Status last verified
- Mar 2026
- First submitted
- 18 Nov 2025
- Last updated
- 1 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Scope-PRO: Screening for Supportive Care Needs of Oncological Patients and Professionals - Evaluation of a Short PRO-question Set
- ClinicalTrials.gov ID
- NCT07505498
- Acronym / sponsor ID
- Scope-PRO / 2025-03979
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 900 participants (estimated)
- Lead sponsor
- University Medical Center GoettingenUniversity, hospital or other
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 1 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study 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.
Key inclusion criteria (4 listed)
- Age ≥ 18 years
- Capacity to give consent
- Cancer patients
- Sufficient understanding of the German language
Key exclusion criteria (3 listed)
- Minors
- Lack of capacity to give consent
- Insufficient knowledge of German
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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 (%)
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.
8 secondary outcomes
Participant-Reported Relevance Score of the Core Question Set
Time frame: Baseline
Centre-Level Characteristics and Implementation Practices of PROM-Based Supportive Care Screening
Time frame: Baseline and last-patient-in at the respective institution
Severity of Prespecified Symptoms (Scope-PRO Core Question Set)
Time frame: Baseline
Psychological Distress Score (Scope-PRO Core Question Set)
Time frame: Baseline
Global Quality of Life Score (Scope-PRO Core Question Set)
Time frame: Baseline
Proportion of Participants Reporting Specific Supportive Care Needs at Baseline (Scope-PRO Core Question Set)
Time frame: Baseline
Performance Status Score (Scope-PRO Core Question Set)
Time frame: Baseline
Nutritional Risk Score (Scope-PRO Core Question Set)
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Patient Related Outcome Measures and Supportive Care, run by University Medical Center Goettingen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sabrina Dr. Sulzer (0551 39 62313, sabrina.sulzer@med.uni-goettingen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Participants with Complete Core Question Set Completion at Baseline (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2026.