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

Study Overview
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Brief Summary
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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
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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.

Official Title
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An International Field Study for the Reliability and Validity of the EORTC PATSAT-C33 and the EORTC OUT-PATSAT7 Questionnaires

Conditions
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Cancer

Participation Criteria
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Eligibility Criteria
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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: 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 Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Validate the EORTC PATSAT-C33 questionnaire | Adequacy of confirmatory factor analyses estimates of EORTC PATSAT-C33 and EORTC OUT-PATSAT7 questionnaires | At inclusion | 
| Validate the EORTC OUT-PATSAT7 questionnaire | Adequacy of confirmatory factor analyses estimates of EORTC PATSAT-C33 and EORTC OUT-PATSAT7 questionnaires | At inclusion | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Quality of life, Cancer care pathway, Patient satisfaction, Care improvement