Clinical trial NCT05989191: Study for the Reliability and Validity of the EORTC PATSAT-C33 and the EORTC OUT-PATSAT7 Questionnaires
Official title: An International Field Study for the Reliability and Validity of the EORTC PATSAT-C33 and the EORTC OUT-PATSAT7 Questionnaires
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Cancer
Keywords: Quality of life
Cancer care pathway
Patient satisfaction
Care improvement
Lead sponsor: Institut Curie
Sponsor class: OTHER
First posted: 2023-08-14
Enrollment: 690
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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 outcomes:
measure: Validate the EORTC PATSAT-C33 questionnaire
timeFrame: At inclusion
measure: Validate the EORTC OUT-PATSAT7 questionnaire
timeFrame: At inclusion
Secondary outcomes:
measure: Cross-cultural applicability and acceptability
timeFrame: At inclusion
measure: Reliability including test-retest and internal consistency
timeFrame: change between inclusion and week 2
measure: Validity, including construct (known-group comparisons)
timeFrame: At inclusion
measure: Convergent and divergent validity
timeFrame: At inclusion
measure: Responsiveness to change
timeFrame: change between inclusion and year 1
measure: Cross-cultural invariance of psychometric properties
timeFrame: At inclusion
Other outcomes:
Locations:
city: Paris
country: France
facility: Institut Curie
city: Vandœuvre-lès-Nancy
country: France
facility: Institut de Cancérologie de Lorraine
Study officials:
References: