Digital Support for Multiple Myeloma Quality of Life

CareAcross108 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Enrollment

108

Conditions

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

Interventions

Digital supportBEHAVIORAL

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

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (1)

Alexandra General Hospital

Athens, Greece

RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: From enrollment, until study completion, average 1 year.

Secondary Outcomes

Progression-Free Survival

Progression-free survival: Laboratory-confirmed disease progression or death, measured from study entry

Time frame: At 12 months from each patient's enrollment

Overall Survival

Overall survival: Time to death, measured from study entry

Time frame: At 12 months from each patient's enrollment

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.