Anti-neoplastic Treatment, Based on PRO Data Reported Through a MHealth App Solution in Multiple Myeloma

Sponsor
Odense University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT05724966
Collaborator
(none)
33
1
18.5
1.8

Study Details

Study Description

Brief Summary

Pirmary endpoint: to examine the feasibility of using an mHealth app for reporting of side effects instead of a telephone call from the hospital staff together with examining the perspectives of patients with multiple myeloma and healthcare professionals of this new method for reporting side effects, and to assess organizational aspects. Usual procedure to assess side effect prior to cancer treatment with Bortezomib is a telephone call the day before. With this innovative method investigator aimed to give the patient more independence in their daily life and in that way improve their quality of life.

Condition or Disease Intervention/Treatment Phase
  • Device: mHealth app

Detailed Description

It is a prospective, clinical, parallel mixed-method design with a quantitative core and a qulitative supplementary component. There will be used a Mhealth app called "My Hospital".

Quantitative data will be acquired from time registrations performed by patients and nurses and will be descriptively analyzed applying a micro-costing approach, using cost data per individual. Qualitative data will be obtained from individual, semi-structured interviews with patients and one focus group interview with healthcare professionals and will be analyzed applying a hermeneutic approach.

Eligible for inclusion were patients with MM scheduled for Bortezomib. Moreover, patients should have access to a smartphone, be able to self-report side effects of Bortezomib using a smartphone app, and be willing to participate in a semi-structured interview.

Study Design

Study Type:
Observational
Actual Enrollment :
33 participants
Observational Model:
Other
Time Perspective:
Prospective
Official Title:
Anti-neoplastic Treatment, Based on PRO Data Reported Through a MHealth App Solution in Multiple Myeloma - a Mixed Method Study
Actual Study Start Date :
May 1, 2021
Actual Primary Completion Date :
Sep 1, 2022
Actual Study Completion Date :
Nov 15, 2022

Arms and Interventions

Arm Intervention/Treatment
Registration of side effects

patients are to registrer side effects prior to treatment with Bortezomib through an app.

Device: mHealth app
We wish to examine the perspectives of patients with multiple myeloma and healthcare professionals of this new method for reporting side effects, and to assess organizational aspects. Usual procedure to assess side effect prior to cancer treatment with Bortezomib is a telephone call the day before.

Outcome Measures

Primary Outcome Measures

  1. Time registrations of side effects using an app [18 months]

    PRO data (time registrations of side effects using an app)

  2. patient registration of side effects using an app [18 months]

    PRO data

Secondary Outcome Measures

  1. Qualitative perspectives interview [16 months]

    Through semi-structured interview

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 99 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • patients with MM scheduled for Bortezomib

  • patients should have access to a smartphone

  • patients should be able to self-report side effects of Bortezomib using a smartphone app, and be willing to participate in a semi-structured interview.

Exclusion Criteria:
  • patients had to talk and read danish

Contacts and Locations

Locations

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

Sponsors and Collaborators

  • Odense University Hospital

Investigators

  • Principal Investigator: Jannie Kirkegaard, RN, Odense Universitetshospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Odense University Hospital
ClinicalTrials.gov Identifier:
NCT05724966
Other Study ID Numbers:
  • Fit for treatment
First Posted:
Feb 13, 2023
Last Update Posted:
Feb 13, 2023
Last Verified:
Jan 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
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 Feb 13, 2023