The EORTC QLQ-C30 is supplemented by additional modules. Those modules are
disease specific.
The following modules are currently at an early stage of
development (Phase 1 or Phase 2) by the EORTC Quality of Life Group. As these
modules are in an early stage, they are not available yet. The information
mentioned gives an overview ofimpression on the current activities. It may
also interest people to follow the development process if they want to use
a module in a later stage. From the moment a module reaches the completed Phase
3 category, it will be made available.
For more information on the module, please contact
the module developer (the person named under the specific module).
Modules under development
Modules in Phases 1 / 2
Update of the EORTC QLQ-H&N35 Head and Neck module
EORTC Quality of Life module for Spinal cord compression
EORTC Quality of Life module for Pleural effusion
EORTC Quality of Life module for Nutritional status/symptoms
EORTC Quality of Life module for Cancer of the Vulva
EORTC Quality of Life module for Chronic Myeloid Leukaemia (CML)
EORTC Quality of Life module for Melanoma
EORTC Quality of Life module for Oral
Health
Modules Phases 1 / 2 Completed
EORTC Quality of Life module for Breast reconstruction
EORTC Quality of Life module for Testicular Cancer
EORTC Quality of Life
module for the assessment of QOL in the Elderly patient with cancer (ELD15)
EORTC Quality of Life module for the assessment of Spiritual
Wellbeing: QLQ-SWB38
EORTC Quality of Life module for Cholangiocarcinoma (QLQ-CHC47)
EORTC Quality of Life module for Nasopharyngeal Carcinoma
(QLQ-NPC42)
Modules available for use
The following modules are currently at an advanced stage of development (Phase 3 completed or Phase 4 completed) by the EORTC Quality of Life Group. Those interested in using them should contact Ken Cornelissen for academic requests or Sarah Williams for commercial requests.
Phase 3 Completed
Bladder cancer modules:
QLQ - BLS24, QLQ- BLM30
High-dose chemotherapy module: EORTC QLQ-HDC29
Ophthalmic module: EORTC QLQ-OPT30
Chronic lymphocytic leukaemia module: EORTC QLQ-CLL16
EORTC Quality of Life module for Radiation Proctitis QLQ-PRT21
Endometrial cancer module QLQ-EN34
Brain cancer module: QLQ-BN20
Pancreatic cancer module: QLQ-PAN26
Information module: EORTC QLQ-INFO25
Chemotherapy-induced peripheral neuropathy module: EORTC
QLQ-CIPN20
Carcinoid / Neuroendocrine tumours module: EORTC QLQ-G.I. NET21
Primary liver cancer module: EORTC QLQ-HCC18
EORTC Bone Metastases-Specific Quality of Life Questionnaire
QLQ-BM22
EORTC Quality of Life module for the assessment
of cancer related Fatigue (EORTC QLQ-FA13)
Modules in Phases 1 / 2
EORTC Quality of Life module for Chronic Myeloid Leukaemia (CML)
Lead Investigator:
Dr. Fabio Efficace, Health Outcomes Research Unit, Italian Group for Adult Hematologic Diseases (GIMEMA) Data Center, Rome, Italy
Project Coordinator:
Dr. Mariagrazia Mecoli, Health Outcomes Research Unit, Italian Group for Adult Hematologic Diseases (GIMEMA) Data Center, Rome, Italy
Principal and Associate Investigators:
Prof. Mirjam Sprangers, Academic Medical Center, University of Amsterdam, The Netherlands
Dr. Kim Cocks, Clinical Trials Research Unit, University of Leeds, UK
Prof. Tobias Gedde-Dahl, Section for hematology and stemcelltransplantation, Oslo University Hospital, Norway
Prof. David Joske, Department of Haematology, Sir Charles Gairdner Hospital, Nedlands, Australia
Dr. Susanne Saußele, Scientific Network Management, European LeukemiaNet, Mannheim, Germany
Dr. Ute Kossak, Scientific Network Management, European LeukemiaNet, Mannheim, Germany
Prof. Graeme Smith, Leeds Institute of Oncology, St James's University Hospital, Leeds, UK
Dr. Stephan Pallua, Department of Psychiatry, Innsbruck University Hospital. Innsbruck, Austria
Dr. Massimo Breccia, Department of Hematology, University of Rome, “Sapienza”, Rome, Italy
Prof. Michele Baccarani, Department of Hematology-Oncology “L. and A. Seràgnoli”, S Orsola-Malpighi University Hospital, Bologna, Italy.
Background: Targeted therapies have dramatically changed the treatment of Chronic Myeloid Leukemia (CML) patients by markedly improving patients survival and by making quality of life more acceptable. The impressive survival figures obtained with this class of drugs will make the evaluation of Patient-Reported Outcomes (PROs) even more critical when assessing treatment effectiveness of newer drugs in the near future. There is a pressing need to gain insight into the disease burden and the health status areas that are of major concern for CML patients to better inform them and to eventually support medical decision making.
Current status and phase of development: Phase I and II activities are in progress and a systematic review on PROs in CML patients is being finalized.
Specialist review and consultation: Clinicians will be asked to review current QOL items used in the FACT-Leu, FACT-BRM, EORTC QLQ-CLL16, and EORTC QLQ-HDC29 modules and the QOL issues and items generated from the systematic review recently finalized on PROs in CML patients. The new QOL issues and items generated in preliminary interviews will also be considered.
Budget:. The project was allocated an EORTC QLG grant for module development, Phase I - III.
Contact address: All those interested can contact: Dr. Fabio Efficace, Health Outcomes Research Unit, Italian Group for Adult Hematologic Diseases (GIMEMA) Data Center, Via Rovigo 1, 00185, Rome, Italy Phone: +39 06 441639831; E-mail: f.efficace@gimema.it
EORTC Quality of Life module for Melanoma
Lead Investigator:
Dr Julie Winstanley,Associate Professor in Biostatistics/Provectus Principal Research Fellow, Melanoma Institute Australia, The University of Sydney, Australia
Principal and Associate Investigators:
Professor Madeleine King,Cancer Australia Chair in Cancer Quality of Life; Director, Quality of Life Office, PoCoG, University of Sydney
Professor John Thompson,Director, Melanoma Institute Australia, The University of Sydney
Dr Grahame Simpson, Rehabilitation Studies Unit, The University of Sydney, and the BIRU, Liverpool Health Service
Professor Rick Kefford, Director, Westmead Institute Cancer Research and Director of Clinical Research and Medical Oncology, Melanoma Institute Australia
Interested Collaborators (to date October 2009)
Dr Anna Costantini, Sant‘ Andrea Hospital Sapienza , Psycho-Oncology Unit, The University of Rome, Italy
Dr Anne Brecht Francken, Isala Klinieken Zwolle, Department of Surgery, The Netherlands
Professor Dr Michael Koller, Center for Clinical Studies, University Hospital Regensburg, Germany
Dr Agnes Czimbalmos, EORTC Quality of Life Department, Brussels, Belgium
Associate Professor Dejan Nikolic, Oncosurgeon,University Medical Center Bezanijska Kosa, Serbia
Professor Julia Newton Bishop, Leeds, UK
Dr Marc Moncrieff, Norwich, England, UK
Dr Ahmed Ali-Khan, Senior Registrar, South West Area, England
Dr Philip Brackley (North Area, England)
Dr Susan Gollop (Senior Registrar, New Zealand)
Dr Will McMillan (Plastic Surgeon, New Zealand)
Background: The most commonly used cancer QOL scales have received little critical attention in terms of their performance within melanoma populations and there is a paucity of data on the QOL of melanoma patients in Australia and worldwide. Only two clinically validated QOL instruments designed for use with melanoma patients were identified in a literature search; the FACT-M (Cormier, 2008) and a study specific MM module developed in Sweden (Sigurdardottir, 1993). The study so far also reveals that additional melanoma specific items are required to adequately measure the full range of QOL issues in this population across a range of stages of disease.
Current status and phase of development: Initial funding has been secured to begin the development of the Melanoma QOL module. Phase 1 – 2 activities are in progress in Australia, to be extended to 2 countries in the EU and will be completed early in 2010.
Focus group/interview sessions: To October 2009, 28 interviews have been conducted (20 patients, 8 relatives) involving a total interviewing time of over 13 hours. Transcripts are being prepared for content analysis to begin November 2009. The interviews are lead by an experienced interviewer (Dr Edward White, Osman Consulting Pty Ltd, Sydney). Pertinent melanoma QOL issues will be identified and new items generated.
Specialist review and consultation: Clinicians at the Melanoma Institute of Australia will be asked to review current QOL items used in the FACT-G, FACT-M, MM Module and the new QOL issues and items generated in interviews.
Consumer consultation: Telephone interviews to representatives of several advocacy groups (CanTEEN, Melanoma Patients Australia, and Cancer Council NSW) will take place and data analysed.
Time scale: Phase 1-2 will be completed by December 2009 and a progress report will be submitted to the EORTC QLG for approval, together with an application for funding in the next EORTC GLG grant round in April 2010.
Budget: Phase 1-2 activities in Australia have been funded by a University of Sydney Cancer Research fund grant and ANZMTG funding, (12 months, running from March 2009). Funding may also support several collaborators to participate in Phase 1-2 activities.
Publications/Presentations: The study has been presented at the 7th World Congress on Melanoma (May 12-16 2009) and at a parallel session at the EORTC QLG meeting in Pamplona.
Contact address: Dr Julie Winstanley, Melanoma Institute Australia, University of Sydney, Level 2, 1a Eden St, North Sydney, NSW 2060, Australia. Phone: +612 9911 7271; E-mail: Julie.Winstanley@smu.org.au.
EORTC Quality of Life module for Oral Health
Principal investigator: Marianne Hjermstad (m.j.hjermstad@medisin.uio.no)
Collaborators:
Sheila E. Fisher, Oral and Maxillofacial Surgery, Faculty of Medicine and Health, University of Leeds, UK
Ourania Nicolatou-Galitis, Clinic of Hospital Dentistry, School of Dentistry, University of Athens, Greece
Joachim Weis, Department of Psychooncology, Tumor Biology Center at the University of Freiburg, Germany
Sebastien Montel, Psycho-Oncology Department, Institute Curie, Paris, France
Irma Verdonck, VU University Medical Center, Otolaryngology / Head & Neck Surgery, Amsterdam, the Netherlands
Bente B. Herlofson, Dept. of Oral surgery and Oral Medicine, Faculty of Dentistry, University of Oslo, Norway
Kristin Bjordal, Division of Cancer Medicine and Radiotherapy, Rikshospitalet University Hospital, Oslo, Norway
Background: Oral morbidity caused by the treatment of head and neck cancers is a significant and well-documented problem, and the EORTC Head&Neck module contains some questions on oral side-effects. According to the literature, 40-70% of the patients will experience oral problems, e.g. mucositis, oral infections, pain, xerostomia, dermatitis, osteoradionecrosis etc. However, oral morbidity in patients with cancer outside the H&N is poorly documented as is the impact of oral problems on QoL.
Current status and phase of development: The Oral Health QoL module is close to terminating phase 1. Phase 1A has been completed, with literature reviews, generation of a list of issues for health personnel and interviews with 18 professionals from several specialties (oncologists, oral surgeons, dental hygienists, oncology nurses, dentists) from Norway, Greece and UK. Phase 1B has been completed in all countries; with 133 patient interviews from Norway, France, Germany, Netherlands, UK and Greece.
Time scale: Phase 1 is close to being finalized. All data has been analysed, discussions regarding item reduction of the initial 84 items has started and will be finished during the Pamplona QLG meeting, September 2009. Phase 2, wording and formatting has started, prior to translation. Hopefully Phase 3 will start in the late fall, 2009.
Translations: The preliminary version of the module for Phase 3 will be sent to the translation coordinator in due time.
Budget. The project was allocated an EORTC grant for module development for 18 months, running from Oct 2008.
Publications: Submission of a manuscript is scheduled after the results from Phase 3 are ready.
Contact address: Marianne Jensen Hjermstad, the Cancer Center, Ulleval University Hospital, 0407 Oslo, NORWAY, Phone: +47 23 02 68 28; E-mail: m.j.hjermstad@medisin.uio.no
Modules Phases 1 / 2 Completed
EORTC Quality of Life module for Breast reconstruction
The Breast reconstruction group met for the first time in Paris Spring 2006. Collaborators are:
H. Thomson, Z. Winters, University of Bristol, Department of Clinical Science South Bristol, Bristol, United Kingdom; F. Didier, J.Y. Petit, European Institute of Oncology, Milan, Italy; Y. Brandberg, K. Sandelin, (3) Karolinska University Hospital, Department of Surgery, Stockholm, Sweden and V. Bjelic-Radisic, Graz, Austria.
In Paris, we discussed our provisional issue list in the light of patient and Health care professional interviews already carried out and to organise the issue list into a more logical order.
Our plan for the next 6 months is to complete phase 1 interviews to include all patient groups and to work on translation of the issues to allow interviews to be carried out in each of the countries currently involved, and to progress into phase 2. We will be contacting the translation department regarding advice on translation.
We are approaching the end of phase 1 of module development, with patient interviews ongoing using our 53-point issue list.
Principal investigator: Helen Thomson (hjthomsonhj@aol.com)
EORTC Quality of Life module for Testicular Cancer
Aim of this project is to develop a questionnaire module to assess QoL of men suffering from testicular cancer (TC) in clinical trials and daily clinical practice. The module will comprise issues pertaining to symptoms of testicular cancer, treatment related issues and any additional dimensions of QoL specific to testicular cancer not sufficiently covered by the EORTC QLQ-C30, i.e. treatment side effects, infertility, body image and sexuality.
The TC module will be administered in combination with the EORTC QLQ-C30. It will be constructed according to the EORTC guidelines for developing questionnaire modules.
Currently we are recruiting patients for phase 3 of the EORTC module development process.
Contact address: Bernhard Holzner, Ph.D., Associated Professor, Medical University Innsbruck, Department of Biological Psychiatry, Div. of Psychooncology and Psychoimmunology, Anichstraße 35, A-6020 Innsbruck, Austria. Tel: +43(0)512/504/24253; Fax: +43(0)512/504/24249; E-mail: bernhard.holzner@uki.at
EORTC Quality of Life module for the assessment of QOL in the Elderly patient with cancer (ELD15)
This module has been proposed to address potential deficiencies of the QLQ system for cancer patients who are elderly. Many modules were developed using data from younger patients. Phase 1 data suggested that older patients have different concerns and may need a specific module.
A systematic review and initial patient interviews were carried out, and a list of issues was evaluated by 17 health professionals. A series of interviews with 48 older patients and 40 patients aged 50-69 years led to selection of 45 potential age-specific issues. Phases 1&2 were completed in 2008. in Phase 3, the list of 45 items was administered to 97 older patients and 86 younger patients and the responses have enabled selection (using pre-determined decision rules) of 15 items to form a provisional module. Phase 3 recruitment was completed in April 2009. A draft Report of Phase 3 has been approved by the MDC of the QLG and a paper was submitted for publication in December 2009.
Phase 4 will begin in early 2010, as a collaborative study of the QLG and the EORTC Task force for cancer in the Elderly.
Principal investigator: Colin Johnson (c.d.johnson@soton.ac.uk)
EORTC Quality of Life module for the assessment of Spiritual Wellbeing: QLQ-SWB38
The EORTC QLQ-SWB38 has completed Phase I and II of the module development process, and pilot testing in Phase III is currently underway in Austria, Belgium, Germany, Iceland, Italy, Israel, the Netherlands, Norway, Spain, and the UK. Four domains are hypothesised: Relationships with self, relationships with others, religious/spiritual beliefs and practices, and existential concerns. The module is ‘functional’ rather than ‘substantive’ in nature, that is, it focuses on the function rather than the substance of patients’ beliefs and practices.
The module has been developed to assess spiritual wellbeing in patients with advanced cancer receiving palliative (but not necessarily terminal) care. However, in some instances completion of the questionnaire may cause patients to wish to discuss issues in more depth. So the process may become, of itself, an intervention, and patients may require an appropriate referral afterwards.
Contact address: Ms Teresa Young, Dep.: Lynda Jackson McMillan Centre, Mount Vernon Hospital, Rickmansworth Road, GB Northwood Middlesex HA6 2RN, United Kingdom. Tel.: +44 1923 844878, Fax: +44 1923 844172, E-mail: teresa.young2@nhs.net
EORTC Quality of Life module for Cholangiocarcinoma (QLQ-CHC47)
Recruitment for this module is now taking place in four UK sites in addition to Germany and Taiwan. 100 interviews were conducted using the debriefing module questionnaire of 47 items which is based on the Pancreatic and Liver Metastases modules. Following analysis of these questionnaires the debriefing questionnaire has been modified. The modified questionnaire is called “phase 3 questionnaire” and has 23 questions. We plan to interview another 35 patients on the remaining 23 questions. We hope these interviews will be completed by the end of 2007.
Contact address: Dr John Ramage. MD FRCP. Consultant Physician in Gastroenterology and Hepatology, North Hampshire Hospital, Basingstoke and Kings College Hospital, London. Tel: +44 12 56313637, Fax: +44 12 56313634, E-mail: Ramage@doctors.org.uk
EORTC Quality of Life module for Nasopharyngeal Carcinoma (QLQ-NPC42)
The module for nasopharyngeal carcinoma is intended for patients at all disease stages undergoing conventional radiation, intracavitary brachytherapy, intensity-modulated radiotherapy (IMRT), chemotherapy, lymph node dissection and nasopharyngectomy. In regards to aspects of disease, treatment and psycho-social aspects, 46 potentially relevant issues have been derived from the literatures. 37 patients and 10 health care providers have been interviewed for comments on the potential issues list. Currently, the list of issues is ready for turning them into items by using EORTC Item bank. Two additional health care providers are invited for final comments of the item list before it is administered to patients in the pre-testing phase.
Contact: Benny, CY Zee, Center for Clinical Trials, School of Public Health, Chinese University of Hong Kong, Hong Kong, China SAR. Tel: (852) 2632 1042; Fax: (852) 2632 5816; E-mail: bzee@cuhk.edu.hk
Modules available for use
Phase 3 completed
1. Bladder cancer modules: QLQ - BLS24, QLQ- BLM30
Two bladder cancer modules have been developed; a 24-item questionnaire for patients with superficial bladder cancer (Ta, T1, CIS), and a 30-item questionnaire for patients with muscle invasive bladder cancer (T2, T3, T4a and T4b). The two modules share a number of common items and scales, including those assessing urinary symptoms, bowel symptoms, and sexual functioning. The superficial bladder cancer module contains additional items assessing side effects of intravesical treatment (fever, malaise, convenience of and worry due to repeated cystoscopies). The muscle-invasive bladder cancer module contains additional items assessing urostomy problems, problems associated with the use of a catheter, and body image. These two modules have been translated into several European languages: Danish, Dutch, French, German, Hungarian, Italian, Norwegian, Polish, Portuguese, Russian, Slovak, Spanish, Swedish and Turkish and in Chinese Mandarin (Taiwan). The field testing of these modules will take place in the context of clinical trials of the EORTC Genito-Urinary Tract Cancer Cooperative Group, and other collaborating investigators.
The field testing of these modules will take place in the context of clinical trials of the EORTC Genito-Urinary Tract Cancer Cooperative Group, and other collaborating investigators.
If you would like to use these modules please contact Ken Cornelissen.
Contact address: Dr. N. Aaronson, Netherlands Cancer Institute, Department of Psychosocial Research and Epidemiology, Plesmanlaan 121, 1066 CX Amsterdam, the Netherlands. Tel: +31 20 5122480; Fax: +31 20 6172625; Email: n.aaronson@nki.nl.
2. High-dose chemotherapy module: EORTC QLQ-HDC29
The module is intended for cancer patients undergoing high-dose myeloablative
treatment with haematological stem cell transplantation (allogeneic / autologous
bone marrow transplantation or peripheral stem cell transplantation). It is
targeted for the peri-transplant period, the time during treatment (usually
in hospital) and up to 6 months after the treatment. The QLQ HDC29 module includes
29 items, consisting of 6 multi-item scales and 8 single-items. The multi-items
scales include gastrointestinal side effects (5 items), body image (2 items),
impact on family (4 items), sexuality (2 items), issues during hospital stay
(3 items), worries/anxiety (5 items) The single items cover physical side-effects
(skin problems, fever, aches in bones, urine frequency), ability to finish
things, taking regular drugs, fertility, spirituality. The development process
involved 261 patients in total with a variety of diagnoses (leukaemia, lymphoma,
multiple myeloma, germ-cell tumours) from 4 countries (UK, Germany, Austria
and Norway).
The development process has been published:
Velikova G, Weis J, Hjermstad MJ, Kopp M, Morris P, Watson M, Sezer O; EORTC
Quality of Life Group. The EORTC QLQ-HDC29: A supplementary module assessing
the quality of life during and after high-dose chemotherapy and stem cell transplantation.
Eur J Cancer. 2007, 43: 87-94
Contact address: Prof Galina Velikova, Professor of Psychosocial
and Medical Oncology, St James’s Institute of oncology, Level 4, Bexley
wing, Beckett Street, Leeds LS9 7TF, UK. E-mail: g.velikova@leeds.ac.uk
3. Ophthalmic module: EORTC QLQ-OPT30
The ophthalmic module is intended for patients with uveal melanoma treated with methods such as transpupillary thermotherapy, plaque radiotherapy, proton beam radiotherapy, local resection, and enucleation. The module comprises 26 items for all patiens, and 4 additional items for patients receiving treatments other than enucleation. The questionnaire assesses ocular irritation, vision impairment, headache, worry about recurrent disease, problems with driving, problems with appearance, functional problems due to vision impairment, and problems reading. Pre-testing of the provisional module was conducted in the UK, Sweden, and Finland. A Phase IV study is still to be set up.
Contact address: Dr. Y. Brandberg, Department of oncology, Karolinska University Hospital, S-171 76 Stockholm,Sweden; Phone: +46-8-5177 24 22; E-mail: yvonne.brandberg@ki.se
4. Chronic lymphocytic leukaemia module: EORTC QLQ-CLL16
This module is designed for patients with stage 0 to stage 4 chronic lymphocytic leukaemia. It is comprised of sixteen questions that address five domains of HRQoL important in CLL. There are three multi item scales on: - Fatigue (2 items), treatment side effects and disease symptoms 8 itemss), infection (4 items) and two single item scales on social activities and future health worries.
It was developed using the EORTC recommended guidelines, with additional patient
interviews based on a grounded theory approach. Pilot testing was performed
in England and Germany. The module development committee has approved the first
three phases of development and a paper describing this process is awaiting
publication. Phase four international field-testing has yet to be agreed.
EORTC QLQ-CLL16 is available in the following languages:
Chinese Mandarin (Taiwan), Czech, Danish, Dutch, French, French (Canada), German, Greek, Gujarati, Hindi, Italian, Kannada,
Malayalam, Marathi, Polish, Portuguese (Brazil), Russian, Spanish (Europe/Mexico), Tamil, Telugu and Thai.
Contact address: Shirley Crofts. Haematology Department, Royal South Hants Hospital, Brintons Terrace, Southampton, Hants, England, SO14 0YG. Tel +44(0)2380825811; Email: shirley.crofts@suht.swest.nhs.uk
5. EORTC Quality of Life module for Radiation Proctitis (QLQ-PRT21)
The module for proctitis is intended to assess bowel complications associated with pelvic irradiation for cancers located in the pelvic region. It is likely that the instrument will be suitable for use with non-radiation induced proctitis also.
A list of 38 potentially relevant issues was derived from a literature review. A pilot series of 'in depth' interviews with this list was undertaken to assess coverage and relevance. Feedback from 10 patients and 7 health care providers resulted in a list of 21 items. Systematic comparison with questions in the EORTC item bank led to modification of some questions. An additional pre-test was then conducted with 28 patients and 5 health care professionals to confirm the suitability of questions within the module. The results of the testing of the module in Australia are available in an article published in the International Journal of Radiation Oncology, Biology and Physics, Volume 72, No. 2, pp 522-528.
The module has now been translated into Norwegian, German, French and Italian and pilot tested in these countries.
We will soon be commencing Phase IV of the study which will involve large scale field testing of the module. We would be pleased to hear from clinicians who might be interested in participating in the field testing of the module.
Contact: Dr Nigel Spry, Radiation Oncology Department, Sir Charles Gairdner
hospital, Perth, WA6009, Australia
Tel:+61 8 9346 4900 Fax: :+61 8 9346 3402; E-mail: Nigel.spry@health.wa.gov.au
6. Endometrial cancer module: QLQ-EN34
Endometrial cancer rates have risen over the last two decades, in some countries very significantly due to a combination of factors that includes an ageing population, increased obesity, and exposure to exogenous oestrogens. Endometrial cancer is only just beginning to get the research attention it is due. For many years it was considered to be a surgically treated disease and that adjuvant radiotherapy might only be of benefit to a limited number of ‘at risk’ patients. Current multi-group research efforts aim to identify the high risk patients who may need post-operative radiation with or without chemotherapy, and establish the most effective treatment combination. With this burgeoning research agenda there is a need to develop a specific quality of life (QoL) measure for women with endometrial cancer that is sensitive to the impact of treatments. In addition patients are increasingly encouraged to seek information about the impact of treatment on their QoL so that they can make informed choices about their treatment and care.
The development of a specific module supplemented to the EORTC QLQ-C30 for assessing the QoL of women with endometrial was initiated in 2005. The module has been developed according to the EORTC guidelines following four phases: 1. generation of QoL issues, 2. operationalisation, 3. pre-testing, 4. field-testing. The module comprises issues pertaining to symptoms of endometrial cancer, treatment related issues and any additional dimensions of QoL specific to endometrial cancer not sufficiently covered by the EORTC QLQ-C30.
In phase 1 systematic analysis of the literature took place over a three month period. A list of QoL issues was generated including gastro-intestinal symptoms, urological symptom, body image, menopausal symptoms as well as chemotherapy related symptoms and sexual functioning issues. Based on the issue list a provisional version of the endometrial cancer module was established in phase 2. The module was translated in eight languages (Croatian, Danish, Dutch, German, Italian, Chinese Mandarin (Taiwan), Norwegian and Swedish) and pre-tested simultaneously in 12 countries. Phase 3 was completed in November 2008. The module has undergone psychometric testing in a multicultural setting (phase 4). Patients from 10 countries with various stages of endometrial cancer were recruited. Patient recruitment for the validation study was closed in July 2009. The psychometric analyses confirmed a six multi-item scale structure. Further analyses will be carried out and it is expected that the module will finalized by the end of 2009.
Contact address: Eva Greimel, Medical University Graz, Department of Gynecology, Auenbruggerplatz 14, 8036 Graz, Austria (elfriede.greimel@meduni-graz.at).
7. Brain cancer module: QLQ-BN20
The brain cancer module is intended for patients undergoing chemotherapy or radiotherapy and contains domains and items not covered by the QLQ-C30. It includes 20 items assessing visual disorders, motor dysfunction, disease symptoms (e.g. headaches and seizures), treatment toxicities (e.g. hair loss), communication deficit and assessing future uncertainty (Osoba et al., 1996). A validation study has been performed with English-speaking patients from Canada, the UK and the USA.It has been translated into Arabic, Chinese Mandarin (Taiwan), Czech, Danish, Dutch, Finnish, French, Canadian French, German, Greek, Hebrew, Hindi, Hungarian, Italian, Japanese, Korean, Marathi, Norwegian, Polish, Portuguese, Romanian, Russian, Spanish ( European and American versions) and Swedish.
Contact address: Dr. M. Taphoorn, Medisch Centrum Haaglanden - Westeinde
P.O. Box 432 - Lijnbaan 32,
2501 CK Den Haag,
The Netherlands. Tel: +31 70 3302000; Fax: +31 70 3303113; Email: m.taphoorn@mchaaglanden.nl
8. Pancreatic cancer module: QLQ-PAN26
The pancreatic cancer module is intended for patients at all disease stages undergoing surgical resection, palliative surgical intervention, endoscopic palliation or palliative chemotherapy. The module comprises 26 questions assessing pain, dietary changes, jaundice, altered bowel habit, emotional problems related to pancreatic cancer, and other symptoms (cachexia, indigestion, flatulence, dry mouth, taste changes). Pre-testing of the provisional module was conducted in the UK, Sweden, Spain, Germany, Switzerland, France, Greece, Italy and Hungary. The module is currently being tested in International clinical trials.
The PAN26 has also been tested in chronic pancreatitis, for which a modified version - QLQ-PAN28(CP) – is available.
Contact address: Mr C. Johnson, Dep.: Univ. Surgical Unit, Southampton General Hospital, Tremona Road, Southampton, S016 6YD; Tel.: +44 23 80796145 or 6; Fax: +44 23 80794020; E-mail: c.d.johnson@soton.ac.uk
9. Information module: EORTC QLQ-INFO25
The information module is intended to evaluate the information received by cancer patients in any stage of the treatment and follow-up periods, and in different disease stages. This module can be presented individually, or together with other EORTC questionnaires. The module comprises 25 questions offering a profile of the level of information patients report having in the dimensions of the care process: the disease, medical tests, treatment, other services, other areas (places of care, things patients can do to get well, written information, information on CD, tape or video). Furthermore, it includes some extra optional items mainly meant to provide qualitative information. The module was developed according to the guidelines and approved after formal peer review. Pretesting was carried out in Austria, Croatia, Germany, Italy, Norway, Spain, U.K. and Korea. The field study has finished. It has been carried out with a sample of 509 patients coming from the different European areas (Austria, Croatia, Germany, Italy, Spain, Sweden, U.K.), and Taiwan. The module has been translated into ten languages: Chinese Mandarin (Taiwan), Croatian, Dutch, French, German, Italian, Norwegian, Portuguese, Spanish and Swedish.
Contact address: Juan Ignacio Arraras, Oncology departments, Hospital de Navarra, Irunlarrea 3, 31008 Pamplona, Spain. Email: jiarraras@correo.cop.es.
10. Chemotherapy-induced peripheral neuropathy module: EORTC QLQ-CIPN20
Chemotherapy-induced peripheral neuropathy (CIPN) is a major, potentially dose-limiting side effect of various chemotherapeutic agents. The CIPN20 is a 20-item quality of life questionnaire, which has been developed to elicit patients' experience of symptoms and functional limitations related to CIPN.
The CIPN20 has 3 subscales: a sensory, motor, and autonomic subscale. In combination with the more classical, physician-based clinical rating scales, the CIPN20 should yield a more complete picture of the nature, frequency, and severity of CIPN in a wide range of oncology patient populations. This phase IV questionnaire has been field tested in a large interational clinical trial and the data are currently being analysed.
Contact address: If you want to use this module, you can contact Mr Ken Cornelissen. For more detailed information about the content or methodological part of this questionnaire, please contact Tjeerd Postma, MD, PhD; Dept. of Neurology; VU University Medical Center; PO Box 7057; 1007 MB Amsterdam, The Netherlands; Tel: +31 20 4444893 or 4444444 (sein 6501); Fax: +31 20 4440715 or 31 20 4442800; E mail: TJ.Postma@vumc.nl
11. Carcinoid / Neuroendocrine tumours module: EORTC QLQ-G.I. NET21
The G.I.NET module is intended for use among patients with
G.I. -related Neuroendocrine Tumours, who vary in disease stage and treatments.
The module has completed phase 3 pre-testing where 174 eligible patients were
interviewed. During this phase the questionnaire had 35 questions. This has been
reduced to 21 questions which will be used for a phase 4 validation study. The
module comprises 21 questions assessing disease symptoms, side effects of treatment,
body image, disease related worries, social functioning, communication and sexuality.
The module has been developed according to the guidelines. The Phase IV study
started in October 2006 and aim for recruitment of 400 patients. Currently, 200 patients have been recruited.
The G.I. NET21 is available in the following languages: Czech, Danish, Dutch, English, French, German, Greek, Hebrew, Italian, Polish, Slovak, Spanish and Swedish.
Contact address: Liz Friend, North Hampshire Hospital, Aldermaston Road, Basingstoke RG24 9NA, UK. Email: liz.friend@nhs.net.
12. Primary liver cancer module: EORTC QLQ-HCC18
The module for hepatocellular carcinoma is intended for patients at all disease stages undergoing surgical resection, liver transplantation, transcatheter arterial chemoembolisation, radiofrequency ablation or systemic chemotherapy. The module comprises 18 questions assessing fatigue (3 items), body image (2 items), jaundice (2 items), nutrition (5 items), pain (2 items) and fevers (2 items) and two single items addressing sexual interest and abdominal swelling. Pre-testing of the module was conducted in the UK, Taiwan and Hong Kong. The module is currently being tested in International clinical trials and is available in Arabic, Chinese Mandarin (PRC-China), Mandarin (Taiwan), Cantonese (Hong Kong), Czech, Dutch, English, French, Hindi, Japanese, Korean, Polish, Portuguese (Brazil), Russian, Spanish (Argentina, Mexico, Spain), Swedish, Thai and Vietnamese.
An international validation study, led by Professor Weichu has been opened in 2008. It is expected to take 18 months to complete.
The development of the module is published:
Blazeby JM, Currie E, Zee BCY, Chu Chie W, Poon RT, Garden OJ. Development of a questionnaire module to supplement the EORTC QLQ-C30 to assess quality of life in patients with hepatocellular carcinoma, the EORTC QLQ-HCC18. European Journal of cancer 2004 40: 2439-2444.
Contact address: Dr Weichu Chie. Email: weichu@ntu.edu.tw.
13. EORTC Bone Metastases-Specific Quality of Life Questionnaire (QLQ-BM22)
The Bone Metastases Module (QLQ-BM22) is a set of robust items and scales for assessing quality of life issues not sufficiently covered by the EORTC QLQ-C30 core questionnaire and considered to be relevant for cancer patients with bone metastases in clinical trials. The QLQ-BM22 addresses disease symptoms related to bone metastases or its diagnosis; side effects, complications and other issues related to treatment of bone metastases; and additional quality of life dimensions that are relevant across diagnosis and treatment modalities in management of bone metastases. This 22-item module is composed of four scales: painful sites (5), pain characteristics (3), functional interference (8), and psychosocial aspects (6).
The development of the module included over 600 bone metastases patients from nine countries. Patients were receiving a variety of treatments: chemotherapy and other systemic agents, bisphosphonates, orthopaedic intervention, surgical stabilization, palliative radiotherapy, and symptom management. The module is available in 14 languages (English, Chinese, Danish, Dutch, German, Greek, Spanish, French, Italian, Japanese, Korean, Norwegian, Swedish, and Turkish) and is currently undergoing large-scale international field-testing. If you are interested in participating or for a copy of the module in your language, please contact the Principal Investigator.
Principal investigator: Dr Edward Chow, Toronto Sunnybrook Regional Cancer Center, Canada. (Edward.Chow@sunnybrook.ca)
14. EORTC Quality of Life module for the assessment of cancer related Fatigue (EORTC FA13)
Project coordinator: Weis, J. (D)
Cooperative partners: Collaborators: Andrea Griffin (UK), Andrew Bottomley
(B), Anne Lanceley (UK), Bernhard Holzner (A), Clare Byrne (UK), Claudia
Fleissner (D), Eva Hammerlid (S), Fabio Efficace (IT), Henning Flechtner
(D), Juan Arraras (E), Louise Jones (UK), Susanne Singer (D), Thierry Conroy
(FR), M. Wirtz (D)
The fatigue module has been developed for use in all diagnoses, stages of the disease and treatment settings. It is measuring cancer related fatigue based on a multidimensional approach including physical, emotional and cognitive aspects of fatigue. One global item is assessing the interference of fatigue with activities of daily living. The development of the module has passed phase I/II based on n=36 expert interviews (physicians, nurses, psychologists) from 8 different European countries. The phase II fatigue module was available in two versions: FA-R15 (reduced version with 15 items) to be used in combination with EORTC QLQ-C30; FA25 (with 25 items) to be used without EORTC QLQ C30. FA25 includes items of the EORTC QLQ C30.
EORTC QLQ FA-R15 has been pre-tested as a phase III module according to the EORTC Module Development Guidelines. Patient recruitment in pre-testing the module FA R15 has been finished end of November 2007. We could evaluate data of n=318 patients covering various tumor sites and treatment settings. As collaborators 7 European countries have contributed: France, Germany, Italy, Austria, Sweden, Spain, UK. The final report has been submitted in October 2008 and a revised version has been accepted in April 2009. As result from phase III EORTC QLQ-FA-R15 has been revised into EORTC QLQ-FA13 version as a completed phase III module, which is available for use in clinical trials. Phase IV is planned to be started in Spring 2010.
Contact address: Prof. Dr. J. Weis, Tumor Biology Center at the University of Freiburg. Tel. +49-761-2062220, E-mail: weis@tumorbio.uni-freiburg.de
Item Bank
The aim of the Item Bank is to facilitate the development and use of the EORTC core questionnaire and modules in QOL research in clinical trials. More specifically:
- To store information about the development of module items, the wording and translations of the various items and subscales
- To store information about results from pre-testing and field-testing including psychometric properties when available.
- To compare items and subscales in new modules with those that are already approved.
- To speed up item construction in phase II of the module development procedure
- To act as a data bank for items to be used in ad hoc questionnaires in conjunction with an existing module for specific EORTC trials.
For more information regarding the Item Bank contact Sheila Sanderson, Nejma Blieck.
Quality assurance
Implementing a quality assurance (QA) program is now compulsory across all EORTC groups, with a mandate from the EORTC Board. The minimum requirements include formation of a multi-disciplinary QA committee which meets at regular intervals. The committee should review the group data annually and identify members whose data is of a poor quality. For more information, please contact Colin Johnson (Chair of the Module Development Committee) for all external modules, or Andrew Bottomley (Head of the Quality of Life Department) for Data Center Studies.
Modules that have completed Phase III are available for general use, but although they have been carefully developed and tested for acceptability with patients, they have not undergone psychometric testing in a large international group of patients. Therefore the suggested subscales for those modules are hypothetical and may change after psychometric analysis. Users are advised to perform psychometric analysis of their data prior to undertaking the analysis of their main study data. Validated modules have undergone formal psychometric testing in a large international group of patients and their subscale structure has been confirmed. They can be used in clinical trials and other studies without the need for extensive psychometric analysis. Nevertheless, it is advisable to run some basic psychometric analyses (e.g., calculating Chronbach's alpha coefficients) to ensure that the questionnaire is performing as expected in any specific research setting.
Modules under development are available from the Quality of Life Department. For academic purposes please contact Ken Cornelissen. If you wish to use a module in a commercial setting, please contact Sarah Williams.