Clinical Trials in France / NCT05989191
Active, not recruiting
Observational
Study for the Reliability and Validity of the EORTC PATSAT-C33 and the EORTC OUT-PATSAT7 Questionnaires
NCT05989191 · tracked via the Priya Life Science France tracker
Condition(s) studied
Cancer
Study summary
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.
Eligibility
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.
Primary outcome measure(s)
- Validate the EORTC PATSAT-C33 questionnaire — At inclusion
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 - Validate the EORTC OUT-PATSAT7 questionnaire — At inclusion
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
Trial sites (2)
| Facility | City | Region | Status |
|---|---|---|---|
| Institut Curie | Paris | France | |
| Institut de Cancérologie de Lorraine | Vandœuvre-lès-Nancy | France |
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05989191 on ClinicalTrials.gov ↗ ← All trials in France