Study for the Reliability and Validity of the EORTC PATSAT-C33 and the EORTC OUT-PATSAT7 Questionnaires

NCT05989191 | Active Not Recruiting

• 1 other identifier: IC 2019-07
• Study Type: observational
• Target: 690
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Cancer

Keywords

Quality of life; Cancer care pathway; Patient satisfaction; Care improvement

Outcome Measures

Primary Outcomes (2)

• Validate the EORTC PATSAT-C33 questionnaire

  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

  At inclusion

• Validate the EORTC OUT-PATSAT7 questionnaire

  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

  At inclusion

Secondary Outcomes (6)

• Cross-cultural applicability and acceptability

  At inclusion

• Reliability including test-retest and internal consistency

  change between inclusion and week 2

• Validity, including construct (known-group comparisons)

  At inclusion

• Convergent and divergent validity

  At inclusion

• Responsiveness to change

  change between inclusion and year 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients with cancer care setting as outpatient, chemotherapy day clinic/consultation for oral treatment, ambulatory radiotherapy or consultation for follow-up surveillance or inpatients or surgery ward.

You may qualify if:

• 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:
• Diagnosis of cancer confirmed histologically.
• Patients are 18 years or older (to be adapted for compliance with each country regulation).
• Patients are willing to express their non-opposition to participate in the study.
• Patients are able to read and understand the language of questionnaires.
• Patients have the cognitive ability to complete the questionnaires.
• 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

You may not qualify if:

• Patients will be excluded if they are :
• Participating in another patient-reported outcome investigation that may interfere with this study.
• Experiencing any psychiatric condition or major cognitive impairment that may hamper completion of self-reported questionnaires.

Sponsors & Collaborators

• Institut Curie: lead

Study Sites (2)

Institut Curie

Paris, 75005, France

Location

Institut de Cancérologie de Lorraine

Vandœuvre-lès-Nancy, 54519, France

Location

Related Publications (1)

• Bredart 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 DERIVED

MeSH Terms

Conditions

Neoplasms; Patient Satisfaction

Condition Hierarchy (Ancestors)

Treatment Adherence and Compliance; Health Behavior; Behavior

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2020
• First Posted: August 14, 2023
• Study Start: November 15, 2019
• Primary Completion: November 30, 2024
• Study Completion: March 30, 2025
• Last Updated: February 7, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)