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

Active, not recruiting

• Conditions: Cancer

• Registration Number: NCT05989191
• Lead Sponsor: Institut Curie

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.

Detailed Description

Patient satisfaction is now recognized as an important indicator of care quality. Measures of patient satisfaction with care can facilitate monitoring initiatives for care improvement over time. The EORTC Quality of Life Group has cross-culturally validated a stand-alone in-patient satisfaction with cancer care questionnaire, the IN-PATSAT32. Advances in cancer care delivery required further development of this questionnaire to assess patients' perceived quality of the care received in outpatient cancer care settings. Phase I to III of this process have been completed, resulting in the EORTC PATSAT-C33 satisfaction with cancer care core questionnaire to assess cancer care delivery as a whole and the complementary EORTC OUT-PATSAT7, a questionnaire for the specific outpatient care settings. These questionnaires concern all patients treated for their cancer, in the assessed service, regardless of the stage and type of cancer.

Study Timeline

• Study Start: 2019-11-15
• Study First Submitted: 2020-02-11
• Study First Submitted QC: 2023-08-02
• Study First Posted: 2023-08-14
• Primary Completion: 2024-11-30
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-04
• Last Update Posted: 2025-02-07
• Study Completion: 2025-03-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 690

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
Convergent and divergent validity	At inclusion	Adequacy of estimates of convergent and divergent validity
Responsiveness to change	change between inclusion and year 1	Adequacy of estimates of responsiveness to change
Cross-cultural applicability and acceptability	At inclusion	Adequacy of estimates of cross-cultural applicability and acceptability
Reliability including test-retest and internal consistency	change between inclusion and week 2	Adequacy of estimates for Reliability including test-retest and internal consistency
Validity, including construct (known-group comparisons)	At inclusion	Adequacy of estimates of validity, including construct (known-group comparisons)
Cross-cultural invariance of psychometric properties	At inclusion	Adequacy of estimates of cross-cultural invariance of psychometric properties

Trial Locations

Locations (2)

Institut Curie; 🇫🇷 Paris, France

Institut de Cancérologie de Lorraine; 🇫🇷 Vandœuvre-lès-Nancy, France