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CancerPATSATNCT05989191

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

An observational study of Cancer, run by Institut Curie at 2 sites in France.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cancer
How many people
690 participants
Where
2 sitesFrance
Study dates
15 Nov 2019to 30 Mar 2025
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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 :
  • 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

Who cannot join

  • 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.

Trial locations and contacts

2 sites in 1 country.

France2 sites

  • Institut Curie

    Paris, 75005

  • Institut de Cancérologie de Lorraine

    Vandœuvre-lès-Nancy, 54519

Other trials in France

About this study

Official title: An International Field 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.

Read the 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.

Conditions
Cancer
Keywords
Quality of life, Cancer care pathway, Patient satisfaction, Care improvement
Medical subject headings
Neoplasms, Patient Satisfaction

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Validate the EORTC PATSAT-C33 questionnaire

    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

    Measured: At inclusion

  2. Validate the EORTC OUT-PATSAT7 questionnaire

    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

    Measured: At inclusion

Secondary outcomes (6)

  1. Cross-cultural applicability and acceptability

    Adequacy of estimates of cross-cultural applicability and acceptability

    Measured: At inclusion

  2. Reliability including test-retest and internal consistency

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

    Measured: change between inclusion and week 2

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

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

    Measured: At inclusion

  4. Convergent and divergent validity

    Adequacy of estimates of convergent and divergent validity

    Measured: At inclusion

  5. Responsiveness to change

    Adequacy of estimates of responsiveness to change

    Measured: change between inclusion and year 1

  6. Cross-cultural invariance of psychometric properties

    Adequacy of estimates of cross-cultural invariance of psychometric properties

    Measured: At inclusion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Aug 2023
  2. Study start15 Nov 2019
  3. Primary completion30 Nov 2024
  4. Study completion30 Mar 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
690 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05989191
Sponsor's protocol ID
IC 2019-07
Acronym
PATSAT
Status last verified
Feb 2025
First submitted
11 Feb 2020
Last updated
7 Feb 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Bredart A, Kop JL, Shamieh O, Fox L, Alrjowb W, Conroy T, Turhal NS, Arraras IJ, Bultijnck R, Harle A, Hemelrijck MV, Pinto E, Roth E, Ioannidis G, Costantini A, Chalk T, Young T, Rohde G, Ishiki H, Kikawa Y, Schmidt H, Vassiliou V, Shayler S, Marchal F, Lehmann J. Comorbidity, treatment toxicity and satisfaction with cancer care: an international cross-sectional study based on the EORTC PATSAT-C33 and OUT-PATSAT7. Support Care Cancer. 2026 Feb 13;34(3):198. doi: 10.1007/s00520-026-10433-3.

    PubMed 41686257

  • Bredart A, Kop JL, Shamieh O, Fox L, Alrjoub W, Conroy T, Turhal NS, Arraras IJ, Bultijnck R, Harle A, Van Hemelrijck M, Pinto E, Roth EJU, Ioannidis G, Costantini A, Chalk T, Young T, Rohde G, Ishiki H, Kikawa Y, Schmidt H, Vassiliou V, Shayler S, Marchal F, Amelie A, Lehmann J; EORTC Quality of Life Group. Phase IV international prospective validation of the EORTC patient satisfaction core questionnaire (EORTC PATSAT-C33) and outpatient module (EORTC OUT-PATSAT7). BMC Cancer. 2025 Nov 26;25(1):1824. doi: 10.1186/s12885-025-15119-3.

    PubMed 41299425

Questions about this trial

What is this clinical trial studying?

An observational study of Cancer, run by Institut Curie at 2 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 7 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Validate the EORTC PATSAT-C33 questionnaire (time frame: At inclusion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05989191, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2025.

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