Clinical trial · Observational
Study for the Reliability and Validity of the EORTC PATSAT-C33 and the EORTC OUT-PATSAT7 Questionnaires
An International Field Study for the Reliability and Validity of the EORTC PATSAT-C33 and the EORTC OUT-PATSAT7 Questionnaires
NCT05989191CI-TRIAL-00085631PATSATactive not recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The aim of this study is to validate the EORTC PATSAT-C33 and EORTC OUT-PATSAT7 questionnaires scale structure in a large international field study.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Validate the EORTC PATSAT-C33 questionnaire
- timeFrame
- At inclusion
- description
- Adequacy of confirmatory factor analyses estimates of EORTC PATSAT-C33 and EORTC OUT-PATSAT7 questionnaires PATSAT-C33 scales: * D/Technical Skills * D/Information Exchange D/Affective Behaviour * N/RT Information * N/RT Affective Behaviour * Coordination * Interaction/HCP PATSAT-C33 single items : * Family involvement * Access/parking * Access/way * Environment * Overall care
- measure
- Validate the EORTC OUT-PATSAT7 questionnaire
- timeFrame
- At inclusion
- description
- Adequacy of confirmatory factor analyses estimates of EORTC PATSAT-C33 and EORTC OUT-PATSAT7 questionnaires OUT-PATSAT7 scales: * Convenience * Transition OUT-PATSAT7 single item \- Continuity
Secondary outcomes (6)
- measure
- Cross-cultural applicability and acceptability
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: Patients regardless of cancer site or stage of disease (i.e. local, loco-regional, metastatic, in remission) will be invited to participate if they meet the following criteria: 1. Diagnosis of cancer confirmed histologically. 2. Patients are 18 years or older (to be adapted for compliance with each country regulation). 3. Patients are willing to express their non-opposition to participate in the study. 4. Patients are able to read and understand the language of questionnaires. 5. Patients have the cognitive ability to complete the questionnaires. 6. Patients have had a sufficient experience of the cancer treatment setting : a. For outpatients consulting in a chemotherapy day clinic/consultation for oral treatment, ambulatory radiotherapy or consultation for follow-up surveillance to check for signs of recurrence : i) between 3 to 6 cycles of chemotherapy or at least 2 cycles of other cancer treatment (e.g., biological oral therapy) or ii) between 2 to 6 weeks of radiotherapy or iii) within the 3rd to 24th month post-cancer treatment. b. For inpatients consulting on an oncology or a surgery ward at least 3 days of hospital stay Exclusion Criteria: Patients will be excluded if they are : 1. Participating in another patient-reported outcome investigation that may interfere with this study. 2. Experiencing any psychiatric condition or major cognitive impairment that may hamper completion of self-reported questionnaires.
References
Publications (2)
- DERIVEDBredart A, Kop JL, Shamieh O, Fox L, Alrjowb W, Conroy T, Turhal NS, Arraras IJ, Bultijnck R, Harle A, Hemelrijck MV, Pinto E, Roth E, Ioannidis G, Costantini A, Chalk T, Young T, Rohde G, Ishiki H, Kikawa Y, Schmidt H, Vassiliou V, Shayler S, Marchal F, Lehmann J. Comorbidity, treatment toxicity and satisfaction with cancer care: an international cross-sectional study based on the EORTC PATSAT-C33 and OUT-PATSAT7. Support Care Cancer. 2026 Feb 13;34(3):198. doi: 10.1007/s00520-026-10433-3. PMID 41686257
- DERIVEDBredart A, Kop JL, Shamieh O, Fox L, Alrjoub W, Conroy T, Turhal NS, Arraras IJ, Bultijnck R, Harle A, Van Hemelrijck M, Pinto E, Roth EJU, Ioannidis G, Costantini A, Chalk T, Young T, Rohde G, Ishiki H, Kikawa Y, Schmidt H, Vassiliou V, Shayler S, Marchal F, Amelie A, Lehmann J; EORTC Quality of Life Group. Phase IV international prospective validation of the EORTC patient satisfaction core questionnaire (EORTC PATSAT-C33) and outpatient module (EORTC OUT-PATSAT7). BMC Cancer. 2025 Nov 26;25(1):1824. doi: 10.1186/s12885-025-15119-3. PMID 41299425