Generic EORTC QL Phases I-III

• Research type

  Research Study

• Full title

  Development of an EORTC disease or domain specific quality of life questionnaire Phases I/II & III (Subtitle: Specific Module Name and Phase)

• IRAS ID

  148706

• Contact name

  Teresa Young

• Contact email

  teresa.young2@nhs.net

• Sponsor organisation

  East & North Herts NHS Trust

• Research summary

  Lay summary of study results: This research protocol is a generic protocol to use for different tumour site specific (e.g. thyroid cancer) or domains (e.g. fatigue, patient satisfaction, communication) quality of life questionnaire development for the EORTC phases I-3.
  The EORTC use a modular approach to quality-of-life questionnaire development. This was originally created in 1988 and was published in 1993. Since then, there have been revisions from time to time, but they have all followed a similar development process. Based on the steps in the initial part of the of the development process, a list of QoL issues, specific to the group of patients the module is intended for, is identified through literature reviews and interviews with healthcare professionals and patients.
  The module is constructed. Issues are converted into items and items are translated by the QLD Translation Unit into the languages required for Phase 3. Use of the EORTC QLG Item Library is mandatory in this phase to avoid duplication of existing items.
  A module will be considered to have ‘completed Phase 2’ once the list of QoL issues has been converted into a set of items and a provisional version of the module has been prepared, reviewed and approved. This includes approval by the PMDC co-chairs of the Phase 1/2 report. On approval, the English version of the module will be designated as a Phase 2 module.
  In Phase 3a, the provisional module is pre-tested to identify and solve potential problems in its administration (e.g. the phrasing of questions, the sequence of questions) and to identify missing or redundant issues. In Phase 3b, preliminary testing of the psychometric properties of the provisional module, including scale structure of the module, is performed (Phase 3b). The output of Phase 3b is the semi-final module (designated as a completed Phase 3 module), which will be tested in Phase 4. A module that has completed Phase 3a and 3b and has received the formal approval of the Phase 3 reports by the PMDC co-chairs, is described as having ‘completed Phase 3’. Such modules may be used in clinical trials under certain conditions and with appropriate permission which are detailed on the EORTC QLG website (under “Questionnaires”).

  As this development process is the same in all the tumour site or domain specific quality of life questionnaires it seemed sensible to create a protocol for use in the UK that can have new disease specific or domain specific questionnaire development added as an amendment (now modification). This simplified the process of opening the new questionnaire modules for Development The following questionnaire development programs were added as modifications as part of the protocol:
  PATSAT Protocol Phases I-III v4 25/09/2013 A questionnaire for the assessment of communication between patients and professionals (EORTC QLQ-COMU31). Phase III V. 1 24/01/2014 I-ADL Phase I Protocol RD2013-50 V1 18/09/20215 I-ADL Phases I-III Protocol RD2013-50 (UK 17/07/2017) Survivorship Protocol Phase I RD2013-50 06/08/2014 v2 Phase III development of an EORTC QoL cancer survivorship questionnaire
  Protocol version: 03.4 11-10-2017 UK
  EORTC QoL Fertility Module 1-3 Protocol Version V 1.2 Final, date: 2020-01-22 Phase III WISP (UK) - EORTC WISP (Write in three Symptoms/Problems) Phase III in UK V1.4 02/05/2023

  Lay summary
  In total the study recruited 294 participants.
  Due to capacity and ongoing resource demands, the Sponsor took the decision to close the study and not pursue further phases/modifications under the current protocol.
  The study ran at various sites within the UK, the study Principal Investigators at each site are as follows:
  East and North Hertfordshire Teaching NHS Trust - Chief Investigator and Principal Investigator Dr Romaana Mir Lothian Health Board – Principal Investigator Dr Robin Grant Royal Marsden Hospital – Principal Investigator Olga Husson Queen Elizabeth the Queen Mother Hospital – Principal Investigator Dr Andrew Nordin Basingstoke Hospital – Principal Investigator Dr John Ramage Southampton General Hospital – Principal Investigator Dr Colin Johnson Leeds General Hospital - Principal Investigator Prof. Galina Velikova

  In conclusion for each of the studies:

  Survivorship Protocol Phase I RD2013-50 06/08/2014 v2 & I-ADL Phase I Protocol RD2013-50 Phase III development of an EORTC QoL cancer survivorship questionnaire
  Protocol version: 03.4 11-10-2017 UK
  Survivorship modules above – this phase I-III development module transitioned to Phase IV of testing and has completed phase IV of testing, one questionnaire is validated and the new prostate, colorectal and breast tumour site specific questionnaires are in the final phase of development.
  Phase III report available on request.
  Publication:
  van Leeuwen, M., Kieffer, J. M., Young, T. E., Aaronson, N. K., & van de Poll-Franse, L. V. (2022). Phase III study of the European Organisation for Research and Treatment of Cancer Quality of Life cancer survivorship core questionnaire. Journal of Cancer Survivorship. doi:10.1007/s11764-021-01160-1 publications from Phase IV development are pending.

  Phase III WISP (UK) - EORTC WISP (Write in three Symptoms/Problems) Phase III in UK V1.4 02/05/2023 This module was found to be acceptable and useful for symptom assessment in cancer patients. It was recommended for use alongside the EORTC questionnaires. It has completed testing and been validated for use and is currently available on the EORTC website.
  Publication: Acceptability and usefulness of the EORTC “Write in three Symptoms/Problems “ (WISP): A brief open-ended instrument for symptom assessment in cancer patients Corresponding author: Leslye Alejandra Rojas Concha
  Co-Authors: Juan Ignacio Arrarras; Thierry Conroy; Tara Chalk; Monica Guberti; Bernhard Holzner; Olga Husson; Dagmara Kuliś; Omar Shamieh; Claire Piccinin; María José Puga; Gudrun Rohde; Mogens Groenvold

  Health and Quality of Life Outcomes (2024) 22:28

  https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Ftrack.pstmrk.it%2F3ts%2Fdoi.org%252F10.1186%252Fs12955-024-02244-z%2FNBTI%2FvJrGAQ%2FAQ%2Fca32569a-7416-4951-aa77-d9e32832a471%2F1%2FBpLOaCAyU7&data=05%7C02%7Cbloomsbury.rec%40hra.nhs.uk%7Cde6fd5cd5fb64058a34508dede854fb8%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C639192861315419498%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=3eKO1UR68YXiEpaAzIV5Bk9rm9JRdnVN%2BBl6EAtrNak%3D&reserved=0

  I-ADL Phase I Protocol RD2013-50 V1 18/09/20215 I-ADL Phases I-III Protocol RD2013-50 (UK 17/07/2017) These have completed testing and Phase IV has been submitted and reviewed.
  Publications:
  Corresponding Author: Quirien Oort
  Co-Authors: Linda Dirven, Sietske A.M. Sikkes, Neil Aaronson, Florien Boele, Christine Brannan, Jonas Egeter, Robin Grant, Martin Klein, Irene Lips, Yoshitaka Narita, Hitomi Sato, Monika Sztankay, Günther Stockhammer, Andrea Talacchi, Bernard M. J. Uitdehaag, Jaap C. Reijneveld, Martin J.B. Taphoorn on behalf of the EORTC Quality of Life Group
  Title: Development of an EORTC questionnaire measuring instrumental activities of daily living (IADL) in patients with brain tumours: phase I-III Quality of Life Research (2021) 30:1491-1502
  https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Ftrack.pstmrk.it%2F3ts%2Fdoi.org%252F10.1007%252Fs11136-020-02738-5%2FNBTI%2FvJrGAQ%2FAQ%2Fca32569a-7416-4951-aa77-d9e32832a471%2F2%2FE-fgeigtRV&data=05%7C02%7Cbloomsbury.rec%40hra.nhs.uk%7Cde6fd5cd5fb64058a34508dede854fb8%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C639192861315468555%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=Z0yToWENqGC94yT%2Fn2nnmSmGyJ3JE%2FDaWK4pgNFyyJo%3D&reserved=0
  Further publications pending for Phase IV of development.

  PATSAT Protocol Phases I-III v4 25/09/2013 PATSAT – Satisfaction with Cancer Care – Core Questionnaire - this has completed testing and been validated for use and is currently available on the EORTC website.
  PATSAT Satisfaction with Out-Patient Cancer Care - this has completed testing and been validated for use and is currently available on the EORTC website.
  PATSAT -Satisfaction with In-Patient Cancer Care - this has completed testing and been validated for use and is currently available on the EORTC website
  Publications:
  Corresponding Author: Anne Bredart
  Co-Authors: Jean-Luc Kop; Omar Shamieh; Louis Fox; Waleed Aljowb, Thierry Conroy; Nazim Sedar Turdal; Ignacio Juan Arraras; Renee Bultijnck; Amelie Harle; Mieke Van Hemelrijck; Eleonora Pinto; Eric Roth; Georgios Ioannidis; Anna Costantini; Tara Chalk; Teresa Young; Gudrun Rohde; Hiroto Ishiki; Yuichiro Kikawa; Heike Schmidt; Vassilios Vassiliou; Stephanie Shayler; Frederic Marchal; Jens Lehmann.
  Title: Comorbidity, treatment toxicity and satisfaction with cancer care: an international cross-sectional study based on the EORTC PATSAT-C33 and OUTPATSAT7 Manuscript Number: 7f329357-ef20-461b-84c7-a5e8e1f217ab
  Supportive Care in Cancer (2026) 34:198
  https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Ftrack.pstmrk.it%2F3ts%2Fdoi.org%252F10.1007%252Fs00520-026-10433-3%2FNBTI%2FvJrGAQ%2FAQ%2Fca32569a-7416-4951-aa77-d9e32832a471%2F3%2FKa6VeomFpO&data=05%7C02%7Cbloomsbury.rec%40hra.nhs.uk%7Cde6fd5cd5fb64058a34508dede854fb8%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C639192861315492915%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=zhZozNqS9PJ%2FsMXcNFTbbWawYCtT3g1NN1iHYV7KCAY%3D&reserved=0

  Corresponding Author: Anne Bredart
  Co-Authors: Jean-Luc Kop; Omar Shamieh; Louis Fox; Waleed Aljowb, Thierry Conroy; Nazim Sedar Turdal; Ignacio Juan Arraras; Renee Bultijnck; Amelie Harle; Mieke Van Hemelrijck; Eleonora Pinto; Eric Roth; Georgios Ioannidis; Anna Costantini; Tara Chalk; Teresa Young; Gudrun Rohde; Hiroto Ishiki; Yuichiro Kikawa; Heike Schmidt; Vassilios Vassiliou; Stephanie Shayler; Frederic Marchal; Anota Amelie; Jens Lehmann and EORTC Quality of Life Group.
  Title: Phase IV international prospective validation of the EORTC patient satisfaction core questionnaire (EORTC PATSAT-C33) and outpatient module (EORTC OUT-PATSAT7).
  BMC Cancer (2025) 25:1824
  https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Ftrack.pstmrk.it%2F3ts%2Fdoi.org%252F10.1186%252Fs12885-025-15119-3%2FNBTI%2FvJrGAQ%2FAQ%2Fca32569a-7416-4951-aa77-d9e32832a471%2F4%2FWMfPtVoA26&data=05%7C02%7Cbloomsbury.rec%40hra.nhs.uk%7Cde6fd5cd5fb64058a34508dede854fb8%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C639192861315511773%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=wsRpZmMa3DSDIlKn0D7L79uWnFDCyg%2B10IQbiFQEU28%3D&reserved=0

  Corresponding Author: Anne Bredart
  Co-Authors: Jean-Luc Kop; Omar Shamieh; Louis Fox; Waleed Aljowb, Thierry Conroy; Nazim Sedar Turdal; Ignacio Juan Arraras; Renee Bultijnck; Amelie Harle; Mieke Van Hemelrijck; Eleonora Pinto; Eric Roth; Georgios Ioannidis; Anna Costantini; Tara Chalk; Teresa Young; Gudrun Rohde; Hiroto Ishiki; Yuichiro Kikawa; Heike Schmidt; Vassilios Vassiliou; Stephanie Shayler; Frederic Marchal; Jens Lehmann and EORTC Quality of Life Group.
  Title: Supportive cancer care and patient satisfaction: international prospective longitudinal study – secondary data analysis.
  BMJ Supportive & Palliative Care (2026) 01-3
  https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Ftrack.pstmrk.it%2F3ts%2Fdoi.org%252F10.1136%252Fspcare-2025-006024%2FNBTI%2FvJrGAQ%2FAQ%2Fca32569a-7416-4951-aa77-d9e32832a471%2F5%2FOQ6Npf_udo&data=05%7C02%7Cbloomsbury.rec%40hra.nhs.uk%7Cde6fd5cd5fb64058a34508dede854fb8%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C639192861315529750%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=W1AzjQe268i9rtuA6tGHyDWuHE0NVs7xsEk5wn691u0%3D&reserved=0

  A questionnaire for the assessment of communication between patients and professionals (EORTC QLQ-COMU31). Phase III V. 1 24/01/2014 The EORTC communication module – QLQ-COMU26 – has been developed. Phases I to III of the development process have been performed. Patients and professionals from different cultural areas have participated in the three first phases of the questionnaire development.
  Publications:
  Arraras J.I., Wintner L., Sztankay M., Tomaszewski K., Hofmeister D., Constantini A., Bredart A., Young T., Kuljanic K., Tomaszewska I., Kontogianni M., Chie W., Kulis D., Greimel E., conducted on behalf of the EORTC Quality of Life Group. EORTC QLQ-COMU26: a questionnaire for the assessment of communication between patients and professionals. Phase III of the module development in ten countries. Support Care Cancer 2017; 25 (5):1485-1494.
  https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Ftrack.pstmrk.it%2F3ts%2Flink.springer.com%252Farticle%252F10.1007%252Fs00520-016-3536-0%2FNBTI%2FvJrGAQ%2FAQ%2Fca32569a-7416-4951-aa77-d9e32832a471%2F6%2FthGj9vJbLL&data=05%7C02%7Cbloomsbury.rec%40hra.nhs.uk%7Cde6fd5cd5fb64058a34508dede854fb8%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C639192861315547765%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=IO%2FuD%2FO1RxnLmEppX3aEO86Jgluif9ZBzqk%2Bd9vtL0s%3D&reserved=0
  Arraras J, Sztankay M, Wintner L, Tomaszewski K, Hofmeister D, Costantini A, Bredart A, Young T, Jackson L, Kuljanic K, Tomaszewska I, Kontogianni M, Chie WC, Kulis D, Greimel E. THE EORTC COMMUNICATION-QUESTIONNAIRE: Preliminary results of Phase III and design of the validation study for the EORTC QLQ-COMU26. Poster Presentation at 23rd International Society for Quality of Life Research (ISOQOL), Copenhagen, Denmark, 19 - 22 October 2016.
  The communication module is currently being tested in an international field study: Phase IV of the development process.

  EORTC QoL Fertility Module 1-3 Protocol Version V 1.2 Final, date: 2020-01-22 Fertility – This did not continue to phase III testing and therefore the questionnaire did not continue to development.

• REC name

  London - Bloomsbury Research Ethics Committee

• REC reference

  14/LO/0452

• Date of REC Opinion

  9 May 2014

• REC opinion

  Further Information Favourable Opinion