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Developing Symptom Lists for People with Cancer Treated with Targeted Therapies

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Abstract

Background

Targeted therapies (TTs) have revolutionised cancer treatment with their enhanced specificity of action. Compared with conventional therapies, TTs are delivered over a longer period and often have unusual symptom profiles. Patient-reported outcome measures such as symptom side-effect lists need to be developed in a time-efficient manner to enable a rapid and full evaluation of new treatments and effective clinical management

Objective

The aim of this study was to develop a set of TT-related symptoms and identify the optimal method for developing symptom lists.

Patients and Methods

Symptoms from TT treatment in the context of Chronic Myeloid Leukaemia (CML), HER2-positive breast cancer, or Gastrointestinal Stromal Tumours (GIST) were identified through literature reviews, interviews with healthcare professionals (HCPs) and patients, and patient focus groups. The symptom set was then pilot tested in patients across the three cancer diagnoses: The number of items derived from each source (literature, patients, or HCPs) were compared.

Results

A total of 316 patients and 86 HCPs from 16 countries participated. An initial set of 209 symptoms was reduced to 61 covering 12 symptom categories. Patient interviews made the greatest contribution to the item set.

Conclusions

Symptom lists should be created based on input from patients. The item set described will be applicable to the assessment of new TTs, and in monitoring treatment.

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Acknowledgements

We would like to express our gratitude to the patients and healthcare professionals who took part in this research project and shared their views and experiences. We would also like to acknowledge the support of staff at the collaborating centres.

Author information

Authors and Affiliations

  1. School of Health Sciences, University of Southampton, Southampton, UK

    Samantha C. Sodergren, Sally J. Wheelwright & Anne-Sophie Darlington

  2. Public Health, Policy and Social Sciences, University of Swansea, Swansea, UK

    Deborah Fitzsimmons

  3. Italian Group for Adult Hematologic Disease (GIMEMA), Rome, Italy

    Fabio Efficace

  4. Department of Medical Psychology, Amsterdam University Medical Center, Amsterdam, The Netherlands

    Mirjam Sprangers

  5. Medical Science and Nutrition, Aberdeen University School of Medicine, Aberdeen, UK

    Peter Fayers

  6. Poole Hospital NHS Foundation Trust, Poole, UK

    Amelie Harle

  7. Martin Luther University Halle-Wittenberg, Halle, Germany

    Heike Schmidt

  8. EORTC Quality of Life Department, Brussels, Belgium

    Andrew Bottomley

  9. The Royal Marsden NHS Foundation Trust, Sutton, UK

    Charlotte Benson

  10. Institut Curie, Paris, France

    Anne Bredart

  11. University Hospital Carl Gustav Carus, Dresden, Germany

    Leopold Hentschel

  12. Complejo Hospitalario de Navarra, Navarra, Spain

    Juan Ignacio Arraras

  13. Nicosia General Hospital, Nicosia, Cyprus

    Georgios Ioannidis

  14. The Christie NHS Foundation Trust, Manchester, UK

    Michael Leahy

  15. Maria Sklodowska-Curie Memorial Cancer Centre-Institute of Oncology, Warsaw, Poland

    Iwona Lugowska

  16. National & Kapodistrian University of Athens, Athens, Greece

    Ourania Nicolatou-Galitis

  17. University Clinical Hospital Center Rijeka, Rijeka, Croatia

    Duska Petranovic

  18. Faculty of Health and Sport Sciences, University of Adger, Agder, Norway

    Gudrun E Rohde

  19. Sørlandet Hospital, Kristiansand, Norway

    Gudrun E Rohde

  20. Bank of Cyprus Oncology Centre, Nicosia, Cyprus

    Vasilis Vassiliou

  21. Cancer Sciences, University of Southampton, Southampton, UK

    Colin D. Johnson

Authors
  1. Samantha C. Sodergren
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  22. Colin D. Johnson
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Consortia

the EORTC Quality of Life Group

Corresponding author

Correspondence to Colin D. Johnson.

Ethics declarations

Funding

Funding for this work was awarded by the EORTC Quality of Life Group (QLG) (Reference Number 010/2010). The QLG awarded funding in a competitive peer-reviewed grant application process. The executive Committee of the QLG reviewed and approved the final manuscript before submission for consideration, ‘on behalf of the EORTC QLG’.

Conflict of interest

Juan Ignacio Arraras received funding from “la Caixa” Foundation (ID 1000010434), Caja Navarra Foundation and UNED Pamplona, under agreement LCF/PR/PR15/51100007. The remaining authors declare that they have no conflicts of interest that might be relevant to the contents of this article.

Ethics approval

Ethical approval for this study was awarded for the Lead site (NRES Committee South Central Southampton B 11/SC/0412). Each collaborating centre also received their local approvals.

Consent to participate

All participants gave their informed consent to participate and for their anonymous data to be shared.

Consent for publication

All authors and the EORTC QLG granted their permission for the publication of this article.

Data availability

Raw data generated from this work cannot be shared as permissions were not requested from participants. The symptom set generated from this work is available from the EORTC QLG upon request at https://qol.eortc.org/questionnaires/.

Code availability

Not applicable.

Author contributions

All authors contributed to the manuscript preparation, editing and review.

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Sodergren, S.C., Wheelwright, S.J., Fitzsimmons, D. et al. Developing Symptom Lists for People with Cancer Treated with Targeted Therapies. Targ Oncol 16, 95–107 (2021). https://doi.org/10.1007/s11523-020-00769-z

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