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Trial Title:
Study for the Reliability and Validity of the EORTC PATSAT-C33 and the EORTC OUT-PATSAT7 Questionnaires
NCT ID:
NCT05989191
Condition:
Cancer
Conditions: Keywords:
Quality of life
Cancer care pathway
Patient satisfaction
Care improvement
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
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.
Criteria for eligibility:
Study pop:
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.
Sampling method:
Non-Probability Sample
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Institut Curie
Address:
City:
Paris
Zip:
75005
Country:
France
Status:
Recruiting
Contact:
Last name:
Anne BREDARD, pHd
Investigator:
Last name:
Anne BREDART, pHD
Email:
Principal Investigator
Facility:
Name:
Institut de Cancérologie de Lorraine
Address:
City:
Vandœuvre-lès-Nancy
Zip:
54519
Country:
France
Status:
Completed
Start date:
July 13, 2020
Completion date:
July 13, 2025
Lead sponsor:
Agency:
Institut Curie
Agency class:
Other
Source:
Institut Curie
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05989191
