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Active, Not Recruiting

NCT Number: NCT05989191

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Institut Curie, Paris, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Validate the EORTC PATSAT-C33 questionnaire

    Time frame: 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
  2. Validate the EORTC OUT-PATSAT7 questionnaire

    Time frame: 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 outcomes

  1. Cross-cultural applicability and acceptability

    Time frame: At inclusion

    Adequacy of estimates of cross-cultural applicability and acceptability

  2. Reliability including test-retest and internal consistency

    Time frame: change between inclusion and week 2

    Adequacy of estimates for Reliability including test-retest and internal consistency

  3. Validity, including construct (known-group comparisons)

    Time frame: At inclusion

    Adequacy of estimates of validity, including construct (known-group comparisons)

  4. Convergent and divergent validity

    Time frame: At inclusion

    Adequacy of estimates of convergent and divergent validity

  5. Responsiveness to change

    Time frame: change between inclusion and year 1

    Adequacy of estimates of responsiveness to change

  6. Cross-cultural invariance of psychometric properties

    Time frame: At inclusion

    Adequacy of estimates of cross-cultural invariance of psychometric properties

Sponsors and collaborators

Lead sponsor

Institut Curie

Other

Registry information

Official study title

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

Acronym: PATSAT

Important dates

Study start
2019
Primary completion
2024
Study completion
2025
First posted
Aug 14, 2023
Registry last updated
Feb 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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