Perspectives of Subcutaneous Velcade at Home of Patients With Myeloma.

Sponsor
Karin B. Ø. Dieperink (Other)
Overall Status
Recruiting
CT.gov ID
NCT05163405
Collaborator
(none)
10
1
30
0.3

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

Study Design

Study Type:
Observational
Anticipated Enrollment :
10 participants
Observational Model:
Other
Time Perspective:
Prospective
Official Title:
Perspectives of Subcutaneous Velcade at Home of Patients With Myeloma.
Actual Study Start Date :
Dec 1, 2019
Anticipated Primary Completion Date :
Jan 1, 2022
Anticipated Study Completion Date :
Jun 1, 2022

Outcome Measures

Primary Outcome Measures

  1. Patients experience of self-administration of Velcade [Through study completion, from 01. dec. 2019 until 01. jun. 2022]

    Qualitative interviews with all 10 included patients

Secondary Outcome Measures

  1. Organizational perspective [Through study completion, from 01. dec. 2019 until 01. jun. 2022]

    Patients and health professionals (including pharmacy staff) registration of time spend on treatment on all 10 included patients.

  2. Health care perspective [Through study completion, from 01. dec. 2019 until 01. jun. 2022]

    Focus group interview with healthcare professionals involved in the treatment.

  3. Financial perspective [Through study completion, from 01. dec. 2019 until 01. jun. 2022]

    Evaluation of financial savings on home treatment including healthcare salaries and transportation.

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No

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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Odense University Hospital Odense Denmark 5000

Sponsors and Collaborators

  • Karin B. Ø. Dieperink

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Karin B. Ø. Dieperink, Nurse, PhD, Associate Professor, Odense University Hospital
ClinicalTrials.gov Identifier:
NCT05163405
Other Study ID Numbers:
  • HFE-X 20.01
First Posted:
Dec 20, 2021
Last Update Posted:
Dec 20, 2021
Last Verified:
Dec 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 20, 2021