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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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05989191
Acronym
PATSAT
Enrollment
690
Registered
2023-08-14
Start date
2019-11-15
Completion date
2025-03-30
Last updated
2025-02-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer

Keywords

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

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.

Interventions

None listed

Sponsors

Institut Curie
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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.

Design outcomes

Primary

MeasureTime frameDescription
Validate the EORTC PATSAT-C33 questionnaireAt inclusionAdequacy 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 questionnaireAt inclusionAdequacy 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

MeasureTime frameDescription
Validity, including construct (known-group comparisons)At inclusionAdequacy of estimates of validity, including construct (known-group comparisons)
Convergent and divergent validityAt inclusionAdequacy of estimates of convergent and divergent validity
Cross-cultural applicability and acceptabilityAt inclusionAdequacy of estimates of cross-cultural applicability and acceptability
Cross-cultural invariance of psychometric propertiesAt inclusionAdequacy of estimates of cross-cultural invariance of psychometric properties
Responsiveness to changechange between inclusion and year 1Adequacy of estimates of responsiveness to change
Reliability including test-retest and internal consistencychange between inclusion and week 2Adequacy of estimates for Reliability including test-retest and internal consistency

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 14, 2026