Digital Support for Multiple Myeloma Quality of Life (DigiMyQoL)

June 7, 2026 updated by: CareAcross

Digital Support for Enhancing the Quality of Life of Patients With Multiple Myeloma: An Observational, Randomized, Prospective Study (DigiMyQoL)

The objective of this prospective study is to investigate the quality of life of patients with multiple myeloma and the effectiveness of support provided through a personalized web-based platform.

Specifically, the study will compare Patient-Reported Outcomes (PROs) and the associated improvement in side effects and quality of life achieved through appropriate personalized educational and supportive content.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

108

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
      • Athens, Greece, 11528
        • Recruiting
        • Alexandra General Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adult patients with newly diagnosed or relapsed/refractory multiple myeloma
  • Patients that are able to use the digital platform/application

Exclusion Criteria:

  • Patients that are not able to use the digital platform/application

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1 - Experimental

Participants in this group utilize the personalized digital platform to record adverse events as Patient-Reported Outcomes (PROs). Additionally, they receive short textual personalized educational and supportive material online.

Their standard clinical treatment and monitoring continue unaffected.
Behavioral: Digital support
Personalized educational and supportive material, based on each patients' adverse events reported as PROs, delivered via the online platform.
No Intervention: Arm 2 - Control

Participants in this group utilize the personalized digital platform to record adverse events as Patient-Reported Outcomes (PROs). They only receive an acknowledgement of their submission.

Their standard clinical treatment and monitoring continue unaffected.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Reported Outcomes (PROs)
Time Frame: From enrollment, until study completion, average 1 year.

Patient-Reported Outcomes (PROs) consisting of treatment related side-effects that patients themselves report on the online platform. The reported side-effects will be evaluated throughout the entire duration of the study.

17 side-effects will be captured (each measured as either present or absent) throughout the study:

  1. Ocular toxicity
  2. Fatigue
  3. Diarrhea
  4. Constipation
  5. Neuropathy
  6. Dermatological toxicity
  7. Dyspnoea
  8. Insomnia
  9. Nausea
  10. Vomiting
  11. Dry mouth
  12. Nail problems
  13. Memory problems
  14. Hypertension
  15. Lower extremity oedema
  16. Sexual dysfunction
  17. Bone pain

Only data from patients who report at least 2 times will be eligible for outcome analysis.

The following calculation and evaluation will be conducted:

For each of the two Arms, the percentage of patients who at the final side-effect data collection reported fewer than 50% of the specific side-effects they had reported at previous side-effect data collection timepoints.
From enrollment, until study completion, average 1 year.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-Free Survival
Time Frame: At 12 months from each patient's enrollment
Progression-free survival: Laboratory-confirmed disease progression or death, measured from study entry
At 12 months from each patient's enrollment
Overall Survival
Time Frame: At 12 months from each patient's enrollment
Overall survival: Time to death, measured from study entry
At 12 months from each patient's enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CareAcross

Collaborators

Μedical Association for the Study of Cancer Biology and Treatments (Μ.Α.S.CA.B.T.)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 27, 2025

Primary Completion (Estimated)

March 1, 2028

Study Completion (Estimated)

March 1, 2028

Study Registration Dates

First Submitted

April 21, 2026

First Submitted That Met QC Criteria

June 7, 2026

First Posted (Actual)

June 11, 2026

Study Record Updates

Last Update Posted (Actual)

June 11, 2026

Last Update Submitted That Met QC Criteria

June 7, 2026

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 160/27022025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Quality of Life

Clinical Trials on Digital support

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Belgium

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe