Perspectives of Subcutaneous Velcade at Home of Patients With Myeloma.

Multiple Myeloma Clinical Trial

Official title:

Perspectives of Subcutaneous Velcade at Home of Patients With Myeloma.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05163405
• Other study ID #: HFE-X 20.01
• Status: Completed
• Start date: December 1, 2019
• Est. completion date: June 1, 2022

Study information

• Verified date: November 2022
• Source: Odense University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

In the present study, we have trained 10 patients in subcutaneous self-administration of Velcade. After their training, patients will alternately receive their treatment in the hospital and at home by self-administration. In keeping with common practice, a nurse contacts the patients by telephone before 9.00 am on the day of treatment to ensure that the patient is physically "fit" to receive the medication and to discuss any side effects. To highlight the advantages and disadvantages of the changed treatment practice from the perspectives of both patients and healthcare professionals, data is collected from two consecutive semi-structured interviews with n = 10 patients and n = 1 focus group interview of the healthcare professionals involved. Moreover, time registration of medication administration both at the hospital and in the patients' home is done. The qualitative data will be analyzed via the method of condensation and continual quantitative data will form the basis of a cost-benefit analysis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: June 1, 2022
• Est. primary completion date: January 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion criteria

• Patients must have Multiple Myeloma

• Patients (or their relatives) must be deemed physically and cognitively suitable and willing for self-administration of subcutaneous Velcade

• Patients must be able to understand and speak Danish

• Patients must have received a minimum of 1 treatment cycle in the outpatient clinic

Exclusion criteria

• Lack of willingness to participate in scheduled interviews

• Patients who are cognitively affected

• Must not be receiving trial treatment

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Drug:
• Bortezomib
Self-administration of subcutaneously Velcade.

Locations

Country	Name	City	State
Denmark	Odense University Hospital	Odense

Sponsors (1)

Lead Sponsor	Collaborator
Karin B. Ø. Dieperink

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patients experience of self-administration of Velcade	Qualitative interviews with all 10 included patients	Through study completion, from 01. dec. 2019 until 01. jun. 2022
Secondary	Organizational perspective	Patients and health professionals (including pharmacy staff) registration of time spend on treatment on all 10 included patients.	Through study completion, from 01. dec. 2019 until 01. jun. 2022
Secondary	Health care perspective	Focus group interview with healthcare professionals involved in the treatment.	Through study completion, from 01. dec. 2019 until 01. jun. 2022
Secondary	Financial perspective	Evaluation of financial savings on home treatment including healthcare salaries and transportation.	Through study completion, from 01. dec. 2019 until 01. jun. 2022