Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05306587 |
| Other study ID # |
DAPHNE |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
April 1, 2022 |
| Est. completion date |
January 1, 2024 |
Study information
| Verified date |
April 2024 |
| Source |
Odense University Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical Trial Summary
Multiple myeloma (MM) is the second most common hematological disease in Denmark with an
incidence of approximately 350 diagnosed cases per year. There is no curative treatment yet,
but usually the disease is very sensitive to treatment, and patients have periods of varying
length, where they do not require treatment. Thus the prognosis for MM has improved over
recent years, and the rate of survival has been extended for both younger and elderly
patients. 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. The frequent
hospital appointments increase the patient's exposure for bacteria and viruses which should
be calculated as a potential risk. Furthermore if the patient is an active part of the labor
market, it can be challenging to request freedom to hospital visits.
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.
The aim for this study: We want to examine patients 'and healthcare professionals'
perspectives, the organizational and the socio economic aspects of administering subcutaneous
Daratumumab in their own home to patients with multiple myeloma, and to illuminate the
benefits and challenges of this.
Description:
This study is a prospective, non-randomized, clinical parallel mixed-methods intervention
project using qualitative and quantitative data in the form of semi-structured telephone
interviews, focus group interviews, time registration, registration of patients' contact with
the healthcare system and PRO data. The project will both include patients already being
treated with SC Daratumumab and new patients planned to start Daratumumab treatment = 40
patients in all. The patients will be included in the department of hematology Odense
University Hospital as they are found eligible.
The intervention of the study is home administration of Daratumumab SC by a home nurse,
thereby, changing the administration setting from a hospital setting to at home setting. The
intervention with home administration will be compared to the hospital setting. The patients
will function as their own controls, as treatment will be given alternately at the hospital.
Patients scheduled for Daratumumab SC at home will be phoned by a nurse from the Hematology
Outpatient Clinic the day before planned administration. This procedure is chosen as that it
allows the nurse to determine whether it is justifiable, for the patient to receive treatment
at home. If the nurse and doctor assess that the patient is fit for home administration of
Daratumumab SC, the drug will be ordered at the pharmacy to be delivered to the patient the
following day. Also an electronic message will also be sent to the home nurses with an
instruction to administer Daratumumab SC between 12-02 PM.
Data collection will consist of:
- Semi-structured virtual (or alternative telephone) interviews with participating
patients focusing on benefits / gains versus challenges / disadvantages in regard to the
actual injection, collaboration with the home nurse, delivery of medication,
empowerment, and suggestions for further improvements n = 2 x 10
- Semi-structured interviews with involved home nurses n = 1 x 5.
- Focus group interview with health professionals involved at OUH at the end of the
project n = 1.
- 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 "My hospital"
x 1 weekly n = 40
- Data on quality of life; EORTC custom built satisfaction questionnaire via the app "My
hospital" = 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 "My hospital".
- 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 "My hospital". This ensures that a cure
that is not used is not prepared.
All Suspected Unexpected Serious Adverse Reactions (SUSARs) will be reported to the Danish
National Health Authorities according national law within 7 days after awareness. Since this
is not at clinical trial, but merely a collection of data during a different logistics setup,
the study will be submitted to the Danish Data Protection Agency, however not to the Danish
National Ethical Committee nor the Danish National Health Authorities. Due to this Adverse
Reactions (AEs) will not be systematically registered or reported to the Danish national
health authorities. To make sure the logistics setup is safe for all patients we will
register all unplanned hospitalizations as well as all other related Serious Adverse
Reactions (SAR).
Processing of personal data in the project The project is notified to the Region's Register
so that it complies with the Data Protection Regulation (GDPR). All electronic data will be
stored on a secure SharePoint site that can only be accessed via the project group's work
computer. All physical material is stored behind double-locked doors at the project group's
workplace.
