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

Study Overview
=================
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.

Official Title
-----------------
Anti-neoplastic Treatment, Based on PRO Data Reported Through a MHealth App Solution in Multiple Myeloma - a Mixed Method Study

Conditions
-----------------
Multiple Myeloma

Intervention / Treatment
-----------------
* Device: mHealth app


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Registration of side effects<br>patients are to registrer side effects prior to treatment with Bortezomib through an app. | Device: mHealth app<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time registrations of side effects using an app | PRO data (time registrations of side effects using an app) | 18 months | 
| patient registration of side effects using an app | PRO data | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Qualitative perspectives interview | Through semi-structured interview | 16 months |