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

Completed

• Conditions: Multiple Myeloma
• Interventions: Device: mHealth app

• Registration Number: NCT05724966
• Lead Sponsor: Thomas Lund

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.

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 Timeline

• Study Start: 2021-05-01
• Primary Completion: 2022-09-01
• Study Completion: 2022-11-15
• Study First Submitted: 2023-01-09
• Status Verified: 2023-02
• Study First Submitted QC: 2023-02-10
• Study First Posted: 2023-02-13
• Last Update Submitted: 2023-02-16
• Last Update Posted: 2023-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Registration of side effects	mHealth app	patients are to registrer side effects prior to treatment with Bortezomib through an app.

Primary Outcome Measures

Name	Time	Method
patient registration of side effects using an app	18 months	PRO data
Time registrations of side effects using an app	18 months	PRO data (time registrations of side effects using an app)

Secondary Outcome Measures

Name	Time	Method
Qualitative perspectives interview	16 months	Through semi-structured interview

Trial Locations

Locations (1)

Odense University Hospital; 🇩🇰 Odense, Denmark