Short summary

Velcade is a drug used in combination with other drugs for treatment of multiple myeloma (MM). As a new, possible administration method, patients can now themselves administer Velcade at home. The question is how patients and health care staff experience this new administration method and whether both parties feel safe regarding self-administration in the patients' homes.

Rationale

Multiple Myeloma (MM) is the second most common hematological disease in Denmark with an incidence of approximately 350 diagnosed cases per year. MM is a cancerous disease with abnormal plasma cell growth in the bone marrow - commonly called 'bone marrow cancer'. There is no established healing treatment yet, but the disease is usually very treatment sensitive, and patients will have shorter or longer periods, where they do not require treatment.

Velcade is a drug that is used in combination with other drugs for treatment of (MM). Velcade (Active ingredient: Bortezomib) is a so-called proteasome inhibitor. The proteasome is a structure that breaks down defective proteins in the cell so that they do not accumulate over time.

Treatment with Velcade therefore causes an accumulation of defective proteins in the cell, which leads to cell death. Velcade is a drug used in combination with other drugs for the treatment of MM. The most well-known side effects of Velcade are sensory disorders, orthostatic hypertension, rash and diarrhea or constipation.

Common practice is that patients are contacted by a nurse by telephone on the day of scheduled Velcade administration to assess, whether it is safe for the patient to receive the treatment and to ensure that a cure is not being prepared without being used, as this is financially burdensome. In case of uncertainty, the doctor will be contacted, and then (s)he will decide, whether or not to give the treatment. Recently, a new form of administration has been introduced, which allows patients to administer Velcade by themselves, in their own homes. Subcutaneous Velcade is administered - depending on the treatment schedule - on days 1, 4/5, 8, and 11/12 of a 21 day cycle. Cycle 1 is always given at OUH, so that the patient can be trained in self-administration, while the medicine from cycle 2 and onwards is alternately administered at OUH and at home, i.e. days 1 and 8 are given at OUH and days 4/5 and 11/12 at home.

In the outpatient setting, the visit takes between 20 minutes and 3 hours, depending on, whether the patient is experiencing side effects, has questions, the doctor is delayed, the medication is delayed or the Velcade syringe is delivered without the adapter piece or other unforeseen occurrences. The question is whether the new method of administration reduces this time consumption - for both patient and healthcare professionals - as well as whether patients and health professionals feel comfortable with administration in the patients' own homes? What benefits and barriers do patients experience by administering Velcade in their own homes? OUH has described a vision of a common approach to patients, based primarily on the phrase "Patient first", which among other things entails the involvement of patients and relatives in their own treatment. With this as a starting point, self-administration of subcutaneous Velcade in the home as modified practice has its justification.

We completed a structured literature review where we found that there is scant knowledge of qualitative assessment of self-administration of subcutaneous Velcade in one's own home and the time spent on it, versus outpatient administration. Therefor our purpose is to examine the perspectives of patients and health professionals and the organizational aspects of self-administration of subcutaneous Velcade in the home of patients with myeloma and to highlight the benefits and challenges to this.

Description of the cohort

The goal is to include 10 patients with Multiple Myeloma. The inclusion is made by the physician and the nurse in the outpatient clinic, assessing suitable patients (and relatives) who meet the inclusion and exclusion criteria. The MM patients are being included, in the order that the staff assesses the patients to be suitable for self-administration of subcutaneous Velcade. The inclusion starts when the project description and related documents are completed, which is expected to be approximately November 01, 2019. The inclusion ends when the planned 10 patients have been included.

Data and biological material

The project is a mixed-methods study, where both qualitative and quantitative methods are being used. The study is hypothesis-generating for subsequent qualitative studies. The data collection in the project consists of time registration as well as semi-structured interviews of the patients - and relatives - along with a focus group interview of involved staff. All interviews are recorded and transcribed verbatim. Finally, this data forms the basis for an evaluation report with the results thereof and a scientific article that is sought to be published in European Journal of Cancer Care. The continual quantitative data will be calculated via descriptive statistics. The qualitative data will be analyzed via the method of condensation, in which the essence of the meanings of the interviewees' statements is summarized and subdivided into themes and thereafter into descriptive statements, so that the data is systematically reviewed and divided, and is then able to form the basis for analysis.

Collaborating researchers and departments

Department of Oncology, Odense University Hospital

• Nurse, PhD, Associate Professor Karin Brochstedt Dieperink

Department of Haematology, Odense University Hospital

• Chief Physician, PhD Thomas Lund