Projects

The following modules are currently under development by the EORTC Quality of Life Group.

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 in development

Modules in Phases 1 / 2

EORTC QOL module for children and adolescents
EORTC QOL module for spinal cord compression
EORTC QOL module for pleural effusion
Update of the EORTC QLQ-LC13 lung module
EORTC QOL module for cachexia/nutrition
EORTC QOL module for cancer of the vulva
EORTC QOL module for melanoma

Modules Phases 1 / 2 Completed

EORTC QOL module for chronic myeloid leukaemia (CML)
EORTC QOL module for nasopharyngeal carcinoma: EORTC QLQ-NPC42
EORTC QOL module for oral health
Update of the EORTC QLQ-H&N35 head and neck module
EORTC QOL module for breast reconstruction: EORTC QLQ-BrR31

Modules in development and 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 Department. Those interested in using them should contact Rossella Guzzo for academic requests or Julie Walker for commercial requests.

Phase 3 Completed

Modules in Phases 1 / 2

EORTC QOL module for cancer cachexia and nutritional status

The QLG has approved a project to develop a module dealing with the Quality of Life aspects of involuntary weight loss and cancer cachexia. This module will complement the many scales in existence that measure the severity of cachexia, with a focus on the psychosocial consequences of cachexia. It will be suitable for use in clinical trials, as it will measure directly the consequences for the patient of involuntary weight loss and cachexia.

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

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EORTC QOL module for cancer of the vulva

Principal investigators:
Pernille T. Jensen, Dept. of Gynecology and Obstetrics, Copenhagen University Hospital Herlev, Denmark
Eva Greimel, Dept. of Obstetrics and Gynecology, Medical University Graz, Austria

Collaborators:
Andy Nordin, Lin Davies, East Kent Gynaecological Oncology Centre, UK
Ann Charlotte Waldenström, Dept. of Gynecologic Oncology, Sahlgrenska University Hospital, Sweden
Anne Lanceley, Institute for Women’s Health, UCLH, Gynaecological Cancer Research Centre, UK
Anne Mag Oberguggenberger, Dept. of Psychotherapy and Psychiatry, Medical University Innsbruck, Austria,
Claudia Schmaltz, Dept. of Radiotherapy, University Hospital of Schleswig Holstein, Germany
Dariusz Wydra, Dept of Gynecology and Gynecologic Oncology, Medical University of Gdansk, Poland
Ellen Barlow, The Royal Hospital for women, Gynaecological Cancer Centre, Australia
Ingvild Vistad, Dept. of Gynecology, The Norwegian Radium Hospital, Norway
Jacki Routledge, Dept of Clinical Oncology, The Christie NHS Foundation Trust, UK
John Butler, Dept. of Gynaecological Oncology Royal Marsden Hospital, UK
Karin Bergmark, Karolinska Institutet, Clinical Cancer Epidemiology, Sweden
Karin Kuljanic, Dept. of Gynecology and Obstetrics, University Hospital Center Rijeka, Croatia
Ligita Fröding, Dept. of Gynecology and Obstetrics, Copenhagen University Hospital Herlev, Denmark
Lonneke van der Poll-Franse, Comprehensive Cancer Centre, Eindhoven, The Netherlands
Razvan Galalae, Paul Scherrer Institute, Center of Proton Therapy, Villigen/Zürich, Switzerland
Remi Nout, Carien Creutzberg, Leiden University Medical Center, The Netherlands
Susanne Singer, Dept. of Medical Psychology, University of Leipzig, Germany
Vesna Bjelic Radisic, Dept. of Obstetrics and Gynecology, Medical University Graz, Austria
Wei-Chu Chie, National Taiwan University Hospital, College of Public Health, Taiwan

Background: Vulva cancer most often affects very elderly women. However during the past decades vulva cancer has been increasingly reported also in younger women. The treatment of vulva cancer often involves a mutilating operation in the vulva region and removal of lymphnodes in the inguinal region. Adjuvant or neo-adjuvant chemotherapy and irradiation may be added both to the vulva and the inguinal regions. Treatment induced morbidity is well-described in the literature, but very few studies have evaluated the quality of life of vulva cancer patients. Only one validated questionnaire exists to be used in vulva cancer patients. Additional areas and robust scales need to be developed for this cancer site. It will be a challenge to develop a module to cover quality of life aspects which should apply to both very elderly women and younger women.
Current status and phase of development: A literature review has been carried out and issues related to quality of life aspects have been extracted. A preliminary issue list consisting of 104 issues relating to 14 different aspects of quality of life has been made. The list has been presented for the EORTC Gynaecological Cancer Group and has been commented on and the issue list has been finalized. A protocol has been accepted by the collaborators and collaborators are applying for ethical approval. Phase 1 interviews will be performed in Austria, Denmark, Germany, Taiwan, UK and probably in Brasil (Spanish). All others collaborators will perform interviews for phase 3 and 4.
Time scale: Since vulva cancer is a comparatively rare disease we expect a long recruitment phase. It is our hope that phase 1 interviews can be completed for the spring meeting 2011. If so, the group will discuss the results of the interviews and run a conceptualisation process to operationalise the issues into items. The EORTC item bank will be consulted.
Translations: According to the guidelines, the collaborators translate the issues themselves for the patient- and health professional interviews. After phase 2 formal forward-backward translations will be completed including the expertise of the EORTC translation centre.
Budget: The group has applied for a grant to complete phase 1 and 2.
Publications: A manuscript will be prepared covering phase 1+2.

Contact address: Pernille T. Jensen, Consultant, PhD, Dept. of Gynecology and Obstetrics, G115, laegegangen, Copenhagen University Hospital Herlev, 75, Herlev Ringvej, DK-2730 Herlev.
Phone: 0045 20952061 Email: pernille_jensen@dadlnet.dk

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EORTC QOL module for melanoma

Principal Investigator
A/Professor Julie Winstanley, Principal Research Fellow, Melanoma Institute Australia (MIA), The University of Sydney, Australia

Collaborators
Dr Mia Bergenmar, Karolinska Institure, Stockhholm, Sweden
Prof Bryan Burmeister, Princess Alexander Hopsital, Brisbane, Queensland, Australia
Dr Jennifer Garioch, Norwich and Norfolk University Hospital, Norwich, England
Prof Carlo Rossi, Melanoma and Sarcoma Unit, University of Padova, Padova, Italy
Dr Lonneke van de Poll-Franse, Comprehensive Cancer Centre South, Eindhoven, The Netherlands
Dr Julia Steinbauer, Department of Dermatology, University of Regensburg, Germany
Prof Dejan Nikolic University Medical Center Bezanijska Kosa, Belgrade, Serbia
Prof John Thompson, Melanoma Institute Australia and Chairman of ANZMTG
Dr Eletha Taylor, Auckland City Hospital, Auckland, New Zealand (from October 2011)

Collaborators providing other support to the study
Prof Madeleine King , The Psycho-Oncology Co-operative Research Group (PoCoG), The University of Sydney, Australia
Prof Michael Koller, University of Regensburg, Regensburg, Germany
Dr Andrew Bottomley QOL Department, EORTC Headquarters, Brussels, Belgium
A/Prof Frances Boyle, Patricia Ritchie Cancer Centre, Mater Hospital and Northern Clinical School, Sydney Medical School, University of Sydney
Dr Esther DeVries, Representative of the EORTC Melanoma Clinical Group (expressions of interest from MG members received)

Background: Melanoma is the most serious type of cancer of the skin and is becoming increasingly common worldwide. The melanoma incidence rates in Australia and New Zealand (between 30-40 per 100,000) are about four times higher than those found in North America and the UK and up to ten times higher than in other countries. In Europe, Sweden and Denmark have the highest incidence rates (~16 per 100,000). Melanoma affects all age groups and skin types and the treatment pathway varies considerably according to the stage of the disease. While some patients only need to have melanoma surgically removed once and will require no further treatment, others will have a recurrence that may complicate treatment pathways and is generally associated with a poorer prognosis. About 80% of patients will survive melanoma but will remain at risk for disease progression for many years and therefore melanoma can be considered a chronic, life-threatening disease. Despite the profundity of the illness, there is a paucity of data on the Quality of Life (QoL) of patients with melanoma worldwide. In part, this may be because the most commonly used cancer QoL research scales have received little critical attention in terms of their performance within melanoma populations. Moreover, despite the international movement towards the development of disease-specific QoL questionnaires, little work has been done to develop reliable valid and sensitive measures for specific use in melanoma. 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 preliminary findings of the study so far also reveal 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.

Phase 1 – Australian pilot– Generation of melanoma Quality of Life (QoL) issues completed in Australia: An extensive literature review was conducted by the ANZMTG MEL-QoL research team at the Melanoma Institute Australia (MIA) and a list of QoL issues was generated which the literature indicated were pertinent to melanoma patients. In addition, 32 semi-structured interviews were conducted at MIA with patients and relatives most closely involved in their care. The interviews were recorded, transcribed verbatim and subject to content analysis by an experienced health care social researcher (Professor Edward White, Associate Investigator). A wide range of issues emerged, in varying degrees of importance; principal amongst them were ‘information seeking and provision’, ‘support’ and the occurrence of ‘dark thoughts’. It was noticeable that many of the issues for melanoma patients were generic and applicable to other cancers.

Current status (as October 2011) of EORTC project and phase of development:

Phase 1 – HCP interviews – May to July 2011
46 health care professionals have been interviewed in 8 different countries (English speaking countries: Australia (2 sites), New Zealand and England; Northern Europe: The Netherlands, Germany, and Sweden; Southern Europe: Italy and Serbia), purposively selected to include patients in all stages of melanoma disease, balanced numbers of males/females and treatment phase. The structured interviews were held according to the EORTC module development guidelines and assess whether included issues are relevant or missing and their relative importance.

Phase 1 – Patient interviews – August to December 2011
A minimum of 80 patients will be interviewed in 8 different countries (English speaking countries: Australia (2 sites), New Zealand and England; Northern Europe: The Netherlands, Germany, and Sweden; Southern Europe: Italy and Serbia), purposively selected to include patients in all stages of melanoma disease, balanced numbers of males/females and treatment phase. The structured interviews will be held according to the EORTC module development guidelines and will assess whether included issues are relevant or missing, and will consider their relative importance. 18 interviews already completed in Australia.

At the conclusion of Phase 1, the combination of findings from the literature review and findings from health care professional and patients interviews, will generate a final list of issues for possible inclusion in a module specific to melanoma, to supplement the QLQ-C30.

Phase 2 – Conversion of melanoma QoL issues into set of items(3 months, January to March 2012)
A provisional item list will be constructed based on the mean scores, prevalence ratio, relevance and priority rating of the QoL issue list from Phase 1, according to the EORTC module development guidelines. The EORTC QLG Item Bank will be used to search EORTC modules for existing question wordings matching the provisional list of items. For the remaining issues, not covered by items in the EORTC Item Bank, wording of new items will be developed by the core collaborating group and finalised at the Spring EORTC meeting in Brussels, 14 March 2012.

Phase 3: Pre-testing of provisional module- planned to start April 2012
(additional collaborating countries/sites welcome)

Phase 4: Field testing of final module - planned to start March 2013
(additional collaborating countries welcome)

Budget:Seed funding from the Australian and New Zealand Melanoma Trials Group (ANZMTG) and the University of Sydney have supported the pilot work in Australia and New Zealand. An application to the EORTC QLG Module Development Committee for conducting EORTC Phases 1, 2 and 3 was successful in May 2011. This will support continuing activities in 8 countries in total (3 English speaking and 5 non English speaking) with the aim of development of an EORTC Melanoma module.

Publications/Presentations:The study has been presented at the 7th World Congress on Melanoma (May 12-16, 2009) and at 5 successive EORTC QLG meetings in Pamplona (September 2009), Rome (April 2010), Leipzig (September 2010), Brussels (March 2011) and Innsbruck (September 2011). Julie Winstanley was an Invited Speaker at the 7th International Melanoma Research Centres Meeting, Sydney, 4 November 2010. Publications are progressing.

Contact address: Associate Professor Julie Winstanley, Melanoma Institute Australia, The Poche Centre, 40 Rocklands Road, North Sydney, NSW 2060, Australia Email: Julie.Winstanley@melanoma.org.au Tel: +61 9911 7200,Fax: +61 2 9954 9435

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Modules Phases 1 / 2 Completed

EORTC QOL 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. Annarita Cardoni, 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, KCStats Consultancy, Leeds, UK
Prof. Tobias Gedde-Dahl, Section for hematology and stemcelltransplantation, Oslo University Hospital, Norway
Dr. Giovanni Caocci, Department of Hematology, Binaghi Hospital, Cagliari, Italy
Dr. Susanne Saußele, Scientific Network Management, European LeukemiaNet, Mannheim, Germany
Dr. Ute Kossak, Scientific Network Management, European LeukemiaNet, Mannheim, Germany
Dr. Adel Naeem, University of Baghdad, Baghdad, Iraq
Dr. Stephan Pallua, Department of Psychiatry, Innsbruck University Hospital. Innsbruck, Austria
Prof. Weichu Chie, National Taiwan University, Taipei, Taiwan
Dr. Massimo Breccia, Department of Hematology, University of Rome, “Sapienza”, Rome, Italy
Dr. Lina Eliasson, Centre for Hematology, Imperial College London, Hammersmith Hospital, London, UK
Dr. Maria Benedetta Giannini, Department of Hematology, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Meldola, Italy
Prof. Michele Baccarani,Department of Hematology-Oncology “L. and A. Seràgnoli”, S Orsola-Malpighi University Hospital, Bologna, Italy
Prof. Ourania Nicolatou-Galitis, Clinic of Hospital Dentistry, Dental Oncology Unit Dental School, University of Athens, Greece
Prof. Christina Meyers, MD Anderson Cancer Center, Houston (Texas), USA Dr.David Marin,Centre for Hematology, Imperial College London, Hammersmith Hospital, London, UK
Prof. Lonneke Van de Poll-Franse, Center of Research on Psychology in Somatic Diseases (CoRPS), Tilburg University, Tilburg, Netherlands

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.
In addition to the main goal of devising an internationally validated “CML Quality of Life Questionnaire”, the development of a “CML Symptom Checklist” is also planned.

Current status and phase of development: Phase I and II activities are concluded, Phase III is in progress and a systematic review on PROs in CML patients is being published on a major hematological Journal.

Specialist review and consultation: A list of possible relevant health issues (including symptoms, psychosocial/functional and physical aspects) related to the disease and treatment/s has been identified from screening more than 400 relevant articles. During Phase I, Health Care Providers (HCPs) interviews have been conducted in several countries, ensuring cross-cultural “content validity”. In particular, they have involved 59 HCPs from Australia, Austria, Czech Republic, Germany, Greece, Italy, Netherlands, Norway, Russia, Switzerland, Taiwan and United Kingdom. Phase I patient interviews have been also conducted, on an international basis, and 137 patients have been recruited to ensure content validity. Phase III interviews have started and, up to now, numerous CML patients from a number of Hospitals in different countries have been interviewed. In addition, this project is also relying on the outstanding collaboration of major CML Patient Associations which are very keen in providing their help. During Phase I, 99 patients have filled in an online version of the list of HRQOL issues through the Italian CML patient advocacy website. For Phase III, in an effort to further strength content validity of the questionnaire, CML patients will participate to the study by providing their input through international CML patient advocacy websites.

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

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EORTC QOL module for nasopharyngeal carcinoma: EORTC 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

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EORTC QOL 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, Laboratoire de Psychologie de la Santé, UPV de Metz, France
Susanne Singer, Abteilung Medizinische Psychologie und Medizinische Soziologie, Universität Leipzig, Germany
Irma Verdonck, VU University Medical Center, Otolaryngology / Head & Neck Surgery, Amsterdam, the Netherlands
Judith Raber-Durlacher, Leiden University Medical Center, Amsterdam, the Netherlands
Noam Yarom, Israel, Oral Medicine Clinic, Dep. of Oral & Maxillofacial Surgery, Sheba Medical Center, Tel-Hashomer, Israel
Mia Bergenmar, Department of Oncology, Karolinska University Hospital / Department of Oncology-Pathology, Karolinska Institutet, Stockholm, Sweden
Petter Wilberg, Dept. of Oral surgery and Oral Medicine, Faculty of Dentistry, University of Oslo, Norway
Kristin Bjordal, Department of Oncology, Oslo University Hospital, Radiumhospitalet, Norway
Bente B. Herlofson, Dept. of Oral surgery and Oral Medicine, Faculty of Dentistry, University of 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 now close to finalizing the Phase 3 patient interviews. 110 patients have been included so far (Norway: 30, Greece: 30, Germany: 25, the Netherlands: 25). The UK and Swedish interviews are pending, while another 5 interviews are currently being conducted in Germany. France will not participate in Phase 3, while the Hebrew translation has not yet been finalized.
Time scale: Phase 3 has started aiming to include 120-150 patients before the summer 2011. Reports and results from Phase 3 should be ready for discussion at the 2011 QLG fall meeting.
Translations: The module has been translated according to the normal EORTC procedures into the following 7 languages; English, Norwegian, Swedish, German, Dutch, French and Greek, while the Hebrew translation is pending.
Budget. The project was allocated an EORTC grant for module development, Oct 2008 and the work is proceeding according to the budget.
Publications: Submission of a manuscript is scheduled after the results from Phase 3 are ready, by the end of 2011

Principal investigator: Marianne Jensen Hjermstad, Department of Oncology, Oslo University Hospital Ulleval, 0407 Oslo, NORWAY, Phone: +47 23 02 68 28; E-mail: m.j.hjermstad@medisin.uio.no

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EORTC QOL module for breast reconstruction: EORTC QLQ-BrR31

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;
Judith Mills, The Institute of Cancer Research, Surrey, United Kingdom;
F. Didier, J.Y. Petit, European Institute of Oncology, Milan, Italy;
Y. Brandberg, K. Sandelin, Karolinska University Hospital, Department of Surgery, Stockholm, Sweden
Anne Oberguggenberger, Innsbruck, Austria
We have completed phases 1 and 2 and presented our phase 1 and 2 report in Rome 2010.

We are now beginning phase 3 with the proposed 31-item module. Interviews will be carried out in at least 4 European countries over the coming months, with a view to completing phase 3 by autumn 2011.

Principal investigator: Helen Thomson (hjthomsonhj@aol.com)

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EORTC QOL module for head and neck Cancer (Revision of EORTC QLQ-H&N35)

Principal investigator: Susanne Singer (Susanne.singer@medizin.uni-leipzig.de)

Collaborators:

Juan Ignacio Arraras, Department of Oncology, Hospital de Navarra, Pamplona, Spain
Ingo Baumann, Department of Otolaryngology Head an Neck Surgery, University of Heidelberg, Germany
Wei-Chu Chie, National Health Research Institutes, Taiwan
Andreas Dietz and Andreas Boehm, Department of Otolaryngology Head an Neck Surgery, University of Leipzig, Leipzig, Germany
Sheila E. Fisher, Oral and Maxillofacial Surgery, Faculty of Medicine and Health, University of Leeds, UK
Razvan Galalae, Department of Radiation Therapy, University Hospital Schleswig-Holstein, Campus Kiel, Germany
Ourania Nicolatou-Galitis, Clinic of Hospital Dentistry, School of Dentistry, University of Athens, Greece
Orlando Guntinas-Lichius and Karin Spiegel, Department Otolaryngology and Head an Neck Surgery, Friedrich-Schiller-University, Jena, Germany
Eva Hammerlid, Department of Otolaryngology Head an Neck Surgery, Sahlgrenska University Hospital, Goteburg, Sweden
Bente B. Herlofson, Dept. of Oral Surgery and Oral Medicine, Faculty of Dentistry, University of Oslo, Norway
Marianne Hjermstad, University Hospital Oslo, Norway
Dirk Hofmeister , Department of Medical Psycology, Leipzig University, Germany
Kenneth Jensen, Department of Oncology, Aarhus University Hospital, Denmark
Monica Pinto, Department of Quality of Life, National Cancer Institute and G. Pascale Foundation of Naples, Naples, Italy
Judith Raber-Durlacher, Department of Periodontology, Academic Centre for Dentistry Amsterdam, Amsterdam, the Netherlands
Jyotsna Rimal, Department of Oral Medicine and Radiology, Department of Oral Pathology, College of Dental Surgery, BP Koirala Institute of Health Sciences, Ghopa Camp, Dharan, Nepal
Claudia Schmalz, Department of Radiation Therapy, University Hospital Schleswig-Holstein, Campus Kiel, Germany
Allen Sherman, Behavioral Medicine Division, Winthrop P. Rockefeller Cancer Institute, University of Arkansas for Medical Sciences, Little Rock, Arkansas, USA
Mehment Sen, St. James Institute of Oncology, Leeds, UK
Irma Verdonck-de Leeuw, VU University Medical Center, Otolaryngology / Head & Neck Surgery, Amsterdam, The Netherlands
Noam Yarom, Dep. of Oral & Maxillofacial Surgery, Sheba Medical Center, Tel-Hashomer and Dep. of Oral Pathology and Oral Medicine, School of Dental Medicine, Tel-Aviv University, Tel-Aviv, Israel
Teresa Young, Lynda Jackson Macmillan Centre, Northwook, UK
Paola Zotti, Department of Clinical-Specialty Services & Support, National Cancer Institute CRO-Aviano, Pordenone, Italy

Collaborating Groups: German Larynx Organ Preservation Group, EORTC Head and Neck Cancer Group

Background: The EORTC head and neck specific module was one of the first developed to be used in conjunction with the core questionnaire C30. To date, the H&N35 has been translated into 49 languages and is used worldwide as one of the standard instruments in measuring quality of life in head and neck cancer patients. However, new treatment strategies are emerging and the H&N35 has been criticised for not sufficiently covering side effects related to surgery or chemo-radiation, and especially the combination of these treatment modalities in multimodal therapy concepts. Radiochemotherapy using a combination of several chemotherapeutical drugs has improved patients’ survival but has also considerably increased their morbidity, e.g. severe mucositis, hair loss, neuropathy, or chronic dysphagia. Additionally, biological therapies (e. g. Cetuximab) are used increasingly. The side effects are clinically known to be mainly skin rash and headaches, both not included in the H&N35. Presently, we do not know whether those symptoms have an impact on the QoL of the patients or not.
Current status and phase of development: The revision of the Head and Neck module is in phase III of the development. A systematic literature review is completed with as a result a list of possible new issues. These new issues were tested in conjunction with the “old” issues of the H&N35 and most relevant issues were extracted. Issues were transformed into items that are currently pilot tested internationally.
Time scale: We expect to finalise phase III until September 2012..
Translations: The revised module has been translated into: French, German, Danish, Dutch, Greek, Hebrew, Italian,Swedish,Nepali, Norvegian and Spanish.
Budget: The project was allocated an EORTC QLG grant for module development, Phase III.
Publications: In preparation .

Principal investigator: Susanne Singer, Department of Medical Psychology and Medical Sociology, Leipzig University, Philipp-Rosenthal-Str. 55, 04103 Leipzig, GERMANY, Phone: +49 341 97 15 463 Email: susanne.singer@medizin.uni-leipzig.de

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Modules in development and available for use

Phase 3 completed

EORTC QOL module for testicular cancer: EORTC QLQ-TC26

The EORTC QLQ-TC26 is a module for the assessment of quality of life in patients with testicular cancer. It is intended for use in clinical trials as well as in daily clinical practice. The module comprises the following domains: Treatment Side Effects, Treatment Satisfaction, Future Perspective, Job Problems, Infertility, Family problems, Sexual Activity, Sexual Enjoyment, Sexual Problems, Communication, Body Image Problems, and Testicular Implant Satisfaction. The QLQ-TC26 module has to be administered in combination with the EORTC QLQ-C30.

By now, phase I to III of the EORTC module development procedure have been completed. Pre-testing (phase III) has been done in Australia, Austria, Italy and Spain. Phase IV (field testing) is planned to start in autumn 2011.

Contact address: Bernhard Holzner, Ph.D., Associated Professor, Innsbruck Medical University , Department of Psychiatry and Psychotheraphy, Div. of Psychooncology, Anichstraße 35, A-6020 Innsbruck, Austria. Tel: +43(0)512/504/24253; Fax: +43(0)512/504/24249; E-mail: bernhard.holzner@uki.at

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1. EORTC QOL modules for bladder cancer: EORTC QLQ-BLS24, EORTC 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. For a list of available translations please visit our translations page. 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 Rossella Guzzo.

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.

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2. EORTC QOL module for high-dose chemotherapy: 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

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3. EORTC QOL module for ophthalmic cancer: 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 patients, 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

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4. EORTC QOL module for chronic lymphocytic leukaemia: 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 items), 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 several European languages. For a list of available translations please visit our translations page.

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

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5. EORTC QOL module for radiation proctitis: EORTC QLQ-PRT23

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 several European languages. For a list of available translations please visit our translations page. It is being pilot tested in Norway, Germany, France and Italy. The results from the pilot testing in Europe are now in press in Radiotherapy and Oncology (doi:10.1016/j.radonc.2010.04.001).

The module is now identified as EORTC QLQ PRT23 because two additional items have been identified for inclusion.

We have commenced Phase IV of the study which involves large scale field testing of the module. We are currently recruiting participants in Australia, Canada, France, Germany, Italy and Norway. 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

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6. EORTC QOL module for pancreatic cancer: EORTC 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, UK; Tel.: +44 23 80796145 or 6; Fax: +44 23 80794020; E-mail: c.d.johnson@soton.ac.uk

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7. EORTC QOL module for chemotherapy-induced peripheral neuropathy: 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 Ms Rossella Guzzo. 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 (extension 6501); Fax: +31 20 4440715 or 31 20 4442800; E mail: TJ.Postma@vumc.nl

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8. EORTC QOL module for carcinoid / neuroendocrine tumours: EORTC QLQ-G.I.NET21

The G.I.NET21 module is intended for use among patients with G.I. -related neuroendocrine tumours, who vary in disease stage and treatments.
The phase 4 validation study has recently been completed where 250-260 patients were recruited. Data is currently being analysed.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 EORTC guidelines.
The G.I.NET21 has been translated into several European languages. For a list of available translations please visit our translations page.

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.

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11. EORTC QOL module for cancer related fatigue: EORTC QLQ-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 was submitted in October 2008 and a revised version was accepted in April 2009. As result from phase III EORTC QLQ-FA-R15 was revised into EORTC QLQ-FA13 version as a completed phase III module, which is available for use in clinical trials. Phase IV 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

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12. EORTC QOL module for elderly cancer patients: EORTC QLQ-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. The Report of Phase 3 was approved by the MDC of the QLG and a paper was accepted for publication in April 2009.
Phase 4 will begin in June 2010, as a collaborative study of the QLG and the EORTC Task force for cancer in the Elderly.

Principal investigator: Colin Johnson, E-mail: c.d.johnson@soton.ac.uk

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13. EORTC QOL module for the assessment of spiritual wellbeing: EORTC QLQ-SWB36

The EORTC QLQ-SWB36 has completed Phase I, II and III of the module development process, Phase III pilot testing was conducted in France, Germany, Iceland, Italy, Japan, Spain and the UK, and Phase IV (international field-testing) of the measure is currently underway in over 13 countries. The module is 'functional' rather than 'substantive' - that is, it focuses on the function rather than the substance of respondents' thoughts and beliefs - and four domains are hypothesised: relationship with self, relationships with others, relationship with a higher power, and existential concerns.

The module has been developed to assess spiritual wellbeing in people with advanced cancer receiving palliative (but not necessarily terminal) care. However, assessment and intervention are not clearly separate in this area, since raising issues to do with spiritual concerns can of itself be thought of as the first stage in an intervention. Thus, some respondents may wish to discuss some or all of the issues addressed in the measure in more depth, and may therefore require time for discussion and/or an appropriate referral after they have completed it.

Principal investigators: Teresa Young, Bella Vivat.

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

Dr Bella Vivat, School of Health Sciences and Social Care, Mary Seacole Building, Brunel University, Uxbridge, Middlesex UB8 3PH, United Kingdom. Tel: +44 1895 268850, Email bella.vivat@brunel.ac.uk.

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14. EORTC QOL module for cholangiocarcinoma and gallbladder cancer: EORTC QLQ-BIL21

The BIL21 is intended for use among patients with cholangiocarcinoma and gallbladder cancer, who vary in disease stage and treatments.
The phases 1 to 3 have been completed where 101 and 52 patients have been recruited respectively. The module comprises 21 questions assessing disease symptoms (including jaundice, eating, tiredness, pain and anxiety) and side effects of treatment. The module has been developed according to the EORTC guidelines.
The BIL21 has been translated into several European languages. For a list of available translations please visit our translations page.

Phase 3 is in press with British Journal of Cancer, first author Elizabeth Friend.
The phase 4 validation is due to start in 2011.

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

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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 Dagmara Kulis.

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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 are 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 EORTC Headquarters studies.

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The development process is divided into three phases. Phase 1 and 2 modules are in early stage of development. From completed Phase 3 onwards, modules are available for use.

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.

For more information, please see our Guidelines for Developing Questionnaire Modules.