Digital Support for Multiple Myeloma Quality of Life

NCT07642362 | Recruiting

• 1 other identifier: 160/27022025
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Multiple Myeloma; Patient Reported Outcome (PRO); Supportive Care in Cancer; Quality of Life

Keywords

multiple myeloma; quality of life; qol; patient reported outcome; pro; digital oncology; supportive care

Outcome Measures

Primary Outcomes (1)

• Patient Reported Outcomes (PROs)

  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 Outcomes (2)

• Progression-Free Survival

  At 12 months from each patient's enrollment

• Overall Survival

  At 12 months from each patient's enrollment

Study Arms (2)

Arm 1 - Experimental

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

Arm 2 - Control

NO INTERVENTION

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.

Interventions

Digital support BEHAVIORAL

Personalized educational and supportive material, based on each patients' adverse events reported as PROs, delivered via the online platform.

Arm 1 - Experimental

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• CareAcross: lead
• Μedical Association for the Study of Cancer Biology and Treatments (Μ.Α.S.CA.B.T.): collaborator

Study Sites (1)

Alexandra General Hospital

Athens, 11528, Greece

RECRUITING

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 Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2026
• First Posted: June 11, 2026
• Study Start: February 27, 2025
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2028
• Last Updated: June 11, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)