Validation RTEQ (RadioTherapy Experience Questionnaire) in FrenchQF-EXPERTNCT07133594
Validation of a Questionnaire in the French Language for the Patient Experience in Radiotherapy
A study testing RTEQ (RadioTherapy Experience Questionnaire) in French and EORTC PATSAT-C33 questionnaire in people with Validation RTEQ (RadioTherapy Experience Questionnaire) in French and Patients Requiring Radiotherapy, run by Centre Leon Berard at 1 site in France.
Trial summary
More than 50% of cancer patients have radiotherapy (RT) as part of their care pathway. Scientific and technological advances leads to an increase in demand. The development of hypofractionation is also increasing the capacity to treat more patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Validation RTEQ (RadioTherapy Experience Questionnaire) in French, Patients Requiring Radiotherapy
- What is being tested?
- RTEQ (RadioTherapy Experience Questionnaire) in French and EORTC PATSAT-C33 questionnaire
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 1 siteFrance
- Study dates
- 7 Aug 2025to 30 Nov 2026
- Phase
- Interventional
- 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
Who may be able to join
- Age >= 18 years
- Patient requiring curative external radiotherapy (at least 2 sessions)
- Patient covered by a medical insurance
- Patient informed and not opposing to the study
Who cannot join
- Patient who don't understand or can't read French
- Any congitive impairment or condition likely to limit the use of scales and questionnaires
- Patient requiring tutorship or curatorship or patient deprived of liberty
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Validation of a French-language Questionnaire for Patient Experience in Radiotherapy
More than 50% of cancer patients have radiotherapy (RT) as part of their care pathway. Scientific and technological advances leads to an increase in demand. The development of hypofractionation is also increasing the capacity to treat more patients. These transformations raise questions from an organizational point of view, the quality of care and the response to patient needs.
Several publications highlight that evaluating patient's experience, satisfaction, and collecting their ideas are excellent foundations for delivering patient-centered care (3,4). To assess the patient experience in RT, Olausson et al. developed and validated a questionnaire in English. To this day , this questionnaire has not been validated in French.
Read more
The main objective is to validate the psychometric property of reliability of the Radiotherapy Experience Questionnaire (RTEQ) after its adaptation into French. This project also includes an assessment of patient satisfaction regarding their RT care pathway.
This study is part of a broader initiative aimed at redesigning the patient journey in radiotherapy, and innovating in the tools and in the overall care approach.
Read the detailed description
There will be 4 steps in this study.
- Phase 1: the RTEQ has been adapted into French by a working group. Phase alreaday completed.
- Phase 2: this is the RTEQ pre-test translated into French. Currently in progress. Comprehension of the questionnaire will be assessed in 50 patients at the Centre Leon Berard (CLB) to obtain the final French version. Patients will complete the RTEQ and a debriefing questionnaire at a time. Patients undergoing hypofractionated RT (between 2 and 10 sessions) as well as patients with more than 11 sessions will be included. Patients undergoing hypofractionated RT will complete the questionnaire at the penultimate session. Patients with at least 11 sessions will be included and will complete the questionnaire during the last week of treatment. The debriefing questionnaire has been developed to determine whether the questionnaire is too long, whether each questions are clear and comprehensive or not.
- Phase 3: pre-test analysis. A descriptive analysis of the responses to each item, as well as the debriefing questionnaire, will be carried out. A meeting with the working group will decide on the necessary modifications for a final version.
- Phase 4: Paucicentric study + validation of the psychometric properties of the RTEQ in French.
Patients will complete the RTEQ and the EORTC PATSAT-C33 questionnaire.
- Group 1: For patients undergoing hypofractionated RT: one measurement period, between Days 2 and 7 (Time n°1).
- Group 2: For patients with at least 11 sessions, two measurement periods: during the first week between Days 2 and 7 (Time n°1) and then during the last week (Time n°2).
- Conditions
- Validation RTEQ (RadioTherapy Experience Questionnaire) in French, Patients Requiring Radiotherapy
- Being tested
- RTEQ (RadioTherapy Experience Questionnaire) in French, EORTC PATSAT-C33 questionnaire
- Keywords
- RTEQ, Questionnaire validation, French translation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RTEQ (RadioTherapy Experience Questionnaire) in FrenchOther
Complete the RTEQ questionnaire translated and adapted to the French language in patients receiving external radiotherapy. Depending on the number of radiotherapy sessions received, the questionnaire will be completed 1 or 2 times during the study.
EORTC PATSAT-C33 questionnaireOther
Complete the EORTC-PATSAT-C33 questionnaire after completing the RTEQ questionnaire. Depending on the number of radiotherapy sessions received, the questionnaire will be completed 1 or 2 times during the study.
| Study group | Role | What they receive |
|---|---|---|
| Questionnaires for patients receiving 10 or fewer radiotherapy sessions_ | Experimental | Patients receiving 10 or fewer radiotherapy sessions: Patient will complete two questionnaires only once between Day 2 and Day 7. Receives: Other: RTEQ (RadioTherapy Experience Questionnaire) in French; Other: EORTC PATSAT-C33 questionnaire |
| Questionnaires for patients receiving 11 or more radiotherapy sessions_ | Experimental | Patients receiving 11 or more radiotherapy sessions. They will complete two questionnaires, at two measurement times: between Day 2 and Day 7 and then during the last week. Receives: Other: RTEQ (RadioTherapy Experience Questionnaire) in French; Other: EORTC PATSAT-C33 questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
To validate the psychometric reliability property (internal consistency between items) of the RTEQ questionnaire after translation and adaptation to the French language for the evaluation of the experience of patients receiving external RT.
Cronbach's alpha coefficient for each dimension of the RTEQ from the questionnaire items at Time n°1 (T1)
Measured: Time n°1 : Between Day 2 and Day 7 of radiotherapy
Secondary outcomes (4)
Other psychometric properties of the questionnaire
The validity of the content of the questionnaire (associated criterion: distribution of RTEQ items at Time n°1); The structural validity of the questionnaire (associated criterion: items of the RTEQ questionnaire at Time n°1, confirmatory factor analysis); Comparison of known groups: comparison between patients with hypofractionated RT: maximum 10 sessions (group 1) versus those with more than 10 sessions (group 2) (associated criterion: scores of each RTEQ scale at Time n°1 for group 1 vs Time n°2 for group 2); Convergent and divergent validity (associated criterion: correlation matrix between RTEQ scores vs satisfaction scores of the EORTC PATSAT-C33 questionnaire)
Measured: Time n°1 : between Day 2 and Day7 of radiotherapy for all patients; Time n°2 : during the last week of radiotherapy if patient have more than 10 sessions of radiotherapy
The level of satisfaction of patients treated by RT from the EORTC PATSAT-C33 questionnaire
Scores of each scale of the PATSAT-C33 at Time n°1 (scale graduated from 1 to 5)
Measured: Time n°1: between Day 2 and Day 7 of radiotherapy
The evolution of satisfaction between the first and last week of treatment for patients in group 2
PATSAT-C33 scores at Time n°1 and Time n°2
Measured: Time n°1: between Day 2 and Day 7 of radiotherapy for all patients; Time n°2: during the last week of radiotherapy if patient receive more than 10 sessions of radiotherapy
The impact of the number of RT sessions on the measurement of satisfaction: comparison between patients in group 1 versus those in group 2
Scores of each scale of the PATSAT-C33 at Time n°1 for group 1 vs Time n°2 for group 2
Measured: Time n°1: between Day 2 and Day 7 of radiotherapy for all patients; Time n°2: during the last week of radiotherapy if patient receive more than 10 sessions of radiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2025
- Study start7 Aug 2025
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Validation RTEQ (RadioTherapy Experience Questionnaire) in FrenchStudies of the same condition, open and under way.
- More trials run by Centre Leon BerardThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Leon Berard
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sophie BOISBOUVIER, Msc R&I in Healthcare (RT), Principal investigator, Centre Leon Berard
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07133594
- Sponsor's protocol ID
- ET24-354 - QF-EXPERT
- Other IDs
- 2024-A02830-47
- Acronym
- QF-EXPERT
- Status last verified
- Aug 2025
- First submitted
- 31 Jul 2025
- Last updated
- 21 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of a French-language Questionnaire for Patient Experience in Radiotherapy
- ClinicalTrials.gov ID
- NCT07133594
- Acronym / sponsor ID
- QF-EXPERT / ET24-354 - QF-EXPERT
- Conditions
- Validation RTEQ (RadioTherapy Experience Questionnaire) in French, Patients Requiring Radiotherapy
- Keywords
- RTEQ, Questionnaire validation, French translation
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- Centre Leon BerardUniversity, hospital or other
- Study start
- 7 Aug 2025 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 21 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
More than 50% of cancer patients have radiotherapy (RT) as part of their care pathway. Scientific and technological advances leads to an increase in demand. The development of hypofractionation is also increasing the capacity to treat more patients. These transformations raise questions from an organizational point of view, the quality of care and the response to patient needs.
Several publications highlight that evaluating patient's experience, satisfaction, and collecting their ideas are excellent foundations for delivering patient-centered care (3,4). To assess the patient experience in RT, Olausson et al. developed and validated a questionnaire in English. To this day , this questionnaire has not been validated in French.
The main objective is to validate the psychometric property of reliability of the Radiotherapy Experience Questionnaire (RTEQ) after its adaptation into French. This project also includes an assessment of patient satisfaction regarding their RT care pathway.
This study is part of a broader initiative aimed at redesigning the patient journey in radiotherapy, and innovating in the tools and in the overall care approach.
Detailed description
There will be 4 steps in this study.
- Phase 1: the RTEQ has been adapted into French by a working group. Phase alreaday completed.
- Phase 2: this is the RTEQ pre-test translated into French. Currently in progress. Comprehension of the questionnaire will be assessed in 50 patients at the Centre Leon Berard (CLB) to obtain the final French version. Patients will complete the RTEQ and a debriefing questionnaire at a time. Patients undergoing hypofractionated RT (between 2 and 10 sessions) as well as patients with more than 11 sessions will be included. Patients undergoing hypofractionated RT will complete the questionnaire at the penultimate session. Patients with at least 11 sessions will be included and will complete the questionnaire during the last week of treatment. The debriefing questionnaire has been developed to determine whether the questionnaire is too long, whether each questions are clear and comprehensive or not.
- Phase 3: pre-test analysis. A descriptive analysis of the responses to each item, as well as the debriefing questionnaire, will be carried out. A meeting with the working group will decide on the necessary modifications for a final version.
- Phase 4: Paucicentric study + validation of the psychometric properties of the RTEQ in French.
Patients will complete the RTEQ and the EORTC PATSAT-C33 questionnaire.
- Group 1: For patients undergoing hypofractionated RT: one measurement period, between Days 2 and 7 (Time n°1).
- Group 2: For patients with at least 11 sessions, two measurement periods: during the first week between Days 2 and 7 (Time n°1) and then during the last week (Time n°2).
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Questionnaires for patients receiving 10 or fewer radiotherapy sessions_ | Experimental | Other: RTEQ (RadioTherapy Experience Questionnaire) in French, Other: EORTC PATSAT-C33 questionnairePatients receiving 10 or fewer radiotherapy sessions: Patient will complete two questionnaires only once between Day 2 and Day 7. |
| Questionnaires for patients receiving 11 or more radiotherapy sessions_ | Experimental | Other: RTEQ (RadioTherapy Experience Questionnaire) in French, Other: EORTC PATSAT-C33 questionnairePatients receiving 11 or more radiotherapy sessions. They will complete two questionnaires, at two measurement times: between Day 2 and Day 7 and then during the last week. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age >= 18 years
- Patient requiring curative external radiotherapy (at least 2 sessions)
- Patient covered by a medical insurance
- Patient informed and not opposing to the study
Key exclusion criteria (3 listed)
- Patient who don't understand or can't read French
- Any congitive impairment or condition likely to limit the use of scales and questionnaires
- Patient requiring tutorship or curatorship or patient deprived of liberty
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RTEQ (RadioTherapy Experience Questionnaire) in FrenchComplete the RTEQ questionnaire translated and adapted to the French language in patients receiving external radiotherapy. Depending on the number of radiotherapy sessions received, the questionnaire will be completed 1 or 2 times during the study. | Other | Questionnaires for patients receiving 10 or fewer radiotherapy sessions_, Questionnaires for patients receiving 11 or more radiotherapy sessions_ |
| EORTC PATSAT-C33 questionnaireComplete the EORTC-PATSAT-C33 questionnaire after completing the RTEQ questionnaire. Depending on the number of radiotherapy sessions received, the questionnaire will be completed 1 or 2 times during the study. | Other | Questionnaires for patients receiving 10 or fewer radiotherapy sessions_, Questionnaires for patients receiving 11 or more radiotherapy sessions_ |
Primary outcome
To validate the psychometric reliability property (internal consistency between items) of the RTEQ questionnaire after translation and adaptation to the French language for the evaluation of the experience of patients receiving external RT.
Time frame: Time n°1 : Between Day 2 and Day 7 of radiotherapy
Cronbach's alpha coefficient for each dimension of the RTEQ from the questionnaire items at Time n°1 (T1)
4 secondary outcomes
Other psychometric properties of the questionnaire
Time frame: Time n°1 : between Day 2 and Day7 of radiotherapy for all patients; Time n°2 : during the last week of radiotherapy if patient have more than 10 sessions of radiotherapy
The level of satisfaction of patients treated by RT from the EORTC PATSAT-C33 questionnaire
Time frame: Time n°1: between Day 2 and Day 7 of radiotherapy
The evolution of satisfaction between the first and last week of treatment for patients in group 2
Time frame: Time n°1: between Day 2 and Day 7 of radiotherapy for all patients; Time n°2: during the last week of radiotherapy if patient receive more than 10 sessions of radiotherapy
The impact of the number of RT sessions on the measurement of satisfaction: comparison between patients in group 1 versus those in group 2
Time frame: Time n°1: between Day 2 and Day 7 of radiotherapy for all patients; Time n°2: during the last week of radiotherapy if patient receive more than 10 sessions of radiotherapy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2025.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sophie BOISBOUVIER, Msc R&I in Healthcare (RT) principal investigator
Centre Leon Berard
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RTEQ (RadioTherapy Experience Questionnaire) in French and EORTC PATSAT-C33 questionnaire in people with Validation RTEQ (RadioTherapy Experience Questionnaire) in French and Patients Requiring Radiotherapy, run by Centre Leon Berard at 1 site 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 4 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 21 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
To validate the psychometric reliability property (internal consistency between items) of the RTEQ questionnaire after translation and adaptation to the French language for the evaluation of the experience of patients receiving external RT. (time frame: Time n°1 : Between Day 2 and Day 7 of radiotherapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Aug 2025; AzTrials last refreshed its copy on 7 Nov 2026.