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NCT Number: NCT07133594

Validation of a Questionnaire in the French Language for the 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.

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Validation RTEQ (RadioTherapy Experience Questionnaire) in French Patients Requiring Radiotherapy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Leon Berard

Lyon, 69008, France

About this study

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).

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

RTEQ (RadioTherapy Experience Questionnaire) in French

Other

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 questionnaire

Other

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.

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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 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)

  2. 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

    Scores of each scale of the PATSAT-C33 at Time n°1 (scale graduated from 1 to 5)

  3. 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

    PATSAT-C33 scores at Time n°1 and Time n°2

  4. 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

    Scores of each scale of the PATSAT-C33 at Time n°1 for group 1 vs Time n°2 for group 2

Sponsors and collaborators

Lead sponsor

Centre Leon Berard

Other

Registry information

Official study title

Validation of a French-language Questionnaire for Patient Experience in Radiotherapy

Acronym: QF-EXPERT

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 21, 2025
Registry last updated
Aug 21, 2025

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

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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.