Short summary

Worldwide, assessment of cancer patients´ quality of life through patient-reported outcomes (PRO) during and after treatment is gaining ground. A generic PRO instrument has been developed to capture symptoms and treatment burden associated with haematological malignancies (HM). The HM-PRO is not available in Danish, which is why a translation and validation study is needed. 

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Rationale

Health-related quality of life of patients with haematological malignancies is greatly affected by the disease and its treatment modalities, but this has not been captured in a systematic manner in routine clinical practice. To capture this, patient-reported outcomes (PRO) may help to better understand the actual symptom burden experienced by patients themselves. 

Recently, the "Scientific Working Group for Quality of Life and Symptoms" within the European Haematology Association therefore developed a PRO for haematological malignancies (HM-PRO) in clinical practice. The HM-PRO is a 42-item questionnaire that consists of two parts (A and B). Part A constitutes 24 items associated to impacts on daily life. These items cover six domains in total (Physical well-being, Social well-being, Emotional behavior, Eating & Drinking). Part B is an 18-item questionnaire targeting signs and symptoms specifically related to the disease.

Within the past two decades, the Danish Health Authority has launched four national cancer plans with the aim of improving cancer treatment across all diagnoses. In the latest cancer plan (Cancer Treatment Package IV) from 2016, it is specified that the use of PROs in cancer clinical care should be optimized. The intention is to systematically collect PRO data on health-related quality of life in Danish cancer patients, including those affected by haematological malignancies. Furthermore, as the Danish Cancer Society also aims to incorporate PRO data into the National Danish Clinical Registries, a generic PRO for haematological patients is highly needed. In conclusion, initiatives to include PROs in daily clinical practice, as well as clinical trials are presumed to optimize treatment pathways, contribute to shared decision making and improve the quality of health care and research in Danish cancer patients. 

The aim of this study is to 1) translate and cross-cultural adapt the HM-PRO into Danish and 2) evaluate the measurement properties of the Danish HM-PRO in patients with haematological malignancies.

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Description of the cohort

The general eligible criteria for participation are any of the following haematological diagnoses, derived from the 2008 WHO classification of tumours of haematopoietic and lymphoid tissues (Swerdlow, 2008):

1. Myeloproliferative neoplasm (chronic myeloid leukaemia (CML), polycythaemia vera, essential thrombocythaemia and primary myelofibrosis)

2. Myelodysplastic/myeloproliferative neoplasm

3. Myelodysplastic syndrome (MDS)

4. Acute myeloid leukaemia (AML) and related precursor neoplasms inclusive therapy-related myeloid neoplasms and myeloid sarcoma

5. Precursor lymphoid neoplasm (B and T lymphoblastic leukaemia/lymphoma inclusive acute lymphoid leukaemia (ALL))

6. Mature B, T and NK cell neoplasms (chronic lymphocytic leukaemia (CLL), aggressive and indolent cell non Hodgkin lymphoma and plasma cell myeloma (only multiple myeloma (MM))

7. Hodgkin lymphoma 

Patients must further comply with the following inclusion criteria, 1) age>18 years, 2) able to understand and read Danish, 3) give written informed consent, and 4) have sufficient cognitive function (subjectively decided by the responsible health personal). 

Patients with comorbidity resulting in a high level of symptoms not related to the haematological disease or patients likely to die within 3 months from study enrolment will be excluded.

Data and biological material

Patient-reported (age, gender, education (highest grade completed) and known comorbidity) and physician-reported (cancer type, time since disease diagnose, lines of treatment, current treatment type, comorbidities and ECOG PS) data are collected. In addition, patient-reported outcome data (EORTC QLQ-C30 and FACT-G) are collected and used to validate the HM-PRO.

Collaborating researchers and departments

Department of Haematology, Odense University Hospital

• Lene Kongsgaard, MD, PhD,

Department of Haematology, Copenhagen University Hospital, Rigshospitalet

• Maria Torp Larsen, MD, PhD 
• Christen Lykkegaard Andersen, MD, PhD 

Department of Haematology, Aarhus University Hospital

• Peter Asdahl, MD, PhD 

Department of Haematology

• Statistician Tobias Klausen, PhD

Department of Pharmacy, University of Herfordshire, Hatfield, UK

• Professor Sam Salek