Ireland
--:--IST
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
Phase
Observational
Started
2019-11-15
Last updated
2025-02-07

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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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)

FacilityCityRegionStatus
Institut Curie Paris France
Institut de Cancérologie de Lorraine Vandœuvre-lès-Nancy France
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