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

Cancer Clinical Trial

— PATSAT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05989191
• Other study ID #: IC 2019-07
• Status: Recruiting
• Start date: July 13, 2020
• Est. completion date: July 13, 2025

Study information

• Verified date: August 2023
• Source: Institut Curie
• Contact: Anne BREDART
• Phone: +33 (0)1 44 32 43 50
• Email: anne.bredart[@]curie.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: July 13, 2025
• Est. primary completion date: July 13, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cancer

Locations

Country	Name	City	State
France	Institut Curie	Paris
France	Institut de Cancérologie de Lorraine	Vandœuvre-lès-Nancy

Sponsors (1)

Lead Sponsor	Collaborator
Institut Curie

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Validate the EORTC PATSAT-C33 questionnaire	Adequacy of confirmatory factor analyses estimates of EORTC PATSAT-C33 and EORTC OUT-PATSAT7 questionnaires	At inclusion
Primary	Validate the EORTC OUT-PATSAT7 questionnaire	Adequacy of confirmatory factor analyses estimates of EORTC PATSAT-C33 and EORTC OUT-PATSAT7 questionnaires	At inclusion
Secondary	Cross-cultural applicability and acceptability	Adequacy of estimates of cross-cultural applicability and acceptability	At inclusion
Secondary	Reliability including test-retest and internal consistency	Adequacy of estimates for Reliability including test-retest and internal consistency	change between inclusion et week 2
Secondary	Validity, including construct (known-group comparisons)	Adequacy of estimates of validity, including construct (known-group comparisons)	At inclusion
Secondary	Convergent and divergent validity	Adequacy of estimates of convergent and divergent validity	At inclusion
Secondary	Responsiveness to change	Adequacy of estimates of responsiveness to change	change between inclusion et year 1
Secondary	Cross-cultural invariance of psychometric properties	Adequacy of estimates of cross-cultural invariance of psychometric properties	At inclusion