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

NCT05724966 | Completed DMC

• 1 other identifier: Fit for treatment
• Study Type: observational
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Myeloma

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Qualitative perspectives interview

  16 months

Study Arms (1)

Registration of side effects

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

Device: mHealth app

Interventions

mHealth app DEVICE

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.

Registration of side effects

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with Multiple Myeloma planned treatment with Bortezomib.

You may qualify if:

• 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.

You may not qualify if:

• patients had to talk and read danish

Sponsors & Collaborators

• Thomas Lund: lead

Study Sites (1)

Odense University Hospital

Odense, 5000, Denmark

Location

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Jannie Kirkegaard, RN

  Odense Universitetshospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: January 9, 2023
• First Posted: February 13, 2023
• Study Start: May 1, 2021
• Primary Completion: September 1, 2022
• Study Completion: November 15, 2022
• Last Updated: February 21, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)