OPEN Research Support
head

Study coordinator
Jannie Kirkegaard
Department of Hematology, Odense University Hospital


Projekt styring
Projekt status    Open
 
Data indsamlingsdatoer
Start 01.02.2022  
Slut 01.08.2023  
 



DAPHNE

Short summary

DAPHNE is an open, single-center, mixed-method project. The aim is to investigate home administration of Daratumumab SC reported by both patients (n=40) and healthcare professionals compared to the hospital administration setting. Datacollection will consist of qualitative and quantitative data in the form of semi-structured interviews, focus group interview, time registration, registration of patients' extra contact with the healthcare system and PRO data.


Rationale

Daratumumab is used for patients with relapses of Multiple Myeloma. Daratumumab is administered subcutaneously relatively often which results in frequent attendance appointments at the hospital. With the increasing specialization and centralization that will occur in the coming years, some patients will have very long transport times to the hospital. When patients go to the hospital only to receive their anticancer therapy, their visits are relatively short and the amount of time spend on transportation might appear disproportionate. Since 2016 Daratumumab has been administered intravenous (IV), however, in July 2020, the European Medicine Agency (EMEA) approved subcutaneous (SC) administration of Daratumumab by healthcare professionals /registered nurses (A/S 2020). The hospitals in the Region of Southern Denmark collaborate with the home care sector in the Region of Southern Denmark which enables home nurses to administrate Daratumumab SC. This allows the patient to receive treatment at home, thereby, avoiding the patients increased exposure to bacteria and viruses which is combined with hospital appointments. An IV administration took approximately 3 hours in average, which was comprehensive both time and resource-wise. Daratumumab SC can be administered in approximately 45 minutes resulting in a considerable amount of time savings.

It is thus possible to provide the treatment at home, but it is unknown what significance it has for patients, relatives and health professionals as well as for the economy it is thus possible to provide the treatment at home, but it is unknown what significance it has for patients, relatives and health professionals as well as for the economy. The aim of this project is to investigate the home administration of Daratumumab SC reported by both patients and healthcare professionals compared to the hospital administration setting. Furthermore, this project investigates the hypothesis that the home administration of Daratumumab potentially can reduce the time associated with the administration, thereby, resulting in a socio-economic gain.


Description of the cohort

40 patients with Multiple Myeloma patients will be included in the out patient clinic in Department of Hematology, Odense University Hospital


Data and biological material

• Registration of unplanned contact to the health service during the study period to account for any extra health care usage during home treatment via the app "Mit sygehus" x 1 weekly n = 40

• Data on quality of life; EORTC custom built satisfaction questionnaire via the app "Mit sygehus" = 5 times per patient.

• Registration of the patients evaluation of whether the use of the app "My hospital" can be useful in the future.

• Registration of patients' time used on treatment when at home or when at hospital including transport via the app "Mit sygehus".

• Registration of the outpatient nurses' and home nurses time using the registration form via paper.

• Registration of patients general condition and possible side effects in order to clarify whether they are "fit" for treatment via the app