Perspectives of Subcutaneous Velcade at Home of Patients With Myeloma.

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.

Study Overview

• Status: Completed
• Conditions: Multiple Myeloma
• Intervention / Treatment: Drug: Bortezomib

• Study Type: Observational
• Enrollment (Actual): 10

Contacts and Locations

Study Locations

• Denmark
  • Odense, Denmark, 5000
    • Odense University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with Multiple Myeloma in treatment with Velcade in Department of Hematology X, outpatient clinic, at Odense University Hospital.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Health care perspective	Focus group interview with healthcare professionals involved in the treatment.	Through study completion, from 01. dec. 2019 until 01. jun. 2022
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

Collaborators and Investigators

• Sponsor: Karin B. Ø. Dieperink
• Investigators: Study Director: Karin Brochstedt Dieperink, RN, Odense University Hospital. Department of Oncology.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2019
• Primary Completion (Actual): January 1, 2022
• Study Completion (Actual): June 1, 2022

Study Registration Dates

• First Submitted: December 3, 2021
• First Submitted That Met QC Criteria: December 17, 2021
• First Posted (Actual): December 20, 2021

Study Record Updates

• Last Update Posted (Actual): November 14, 2022
• Last Update Submitted That Met QC Criteria: November 9, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Immunoproliferative Disorders; Hematologic Diseases; Hemorrhagic Disorders; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Multiple Myeloma; Neoplasms, Plasma Cell; Antineoplastic Agents; Bortezomib
• Other Study ID Numbers: HFE-X 20.01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes