Multiple Myeloma, Patient Reported Outcome (PRO), Quality of Life, Supportive Care in Cancer
Conditions
Keywords
multiple myeloma, quality of life, qol, patient reported outcome, pro, digital oncology, supportive care
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.
Interventions
BEHAVIORALDigital support
Personalized educational and supportive material, based on each patients' adverse events reported as PROs, delivered via the online platform.
Sponsors
CareAcross
Μedical Association for the Study of Cancer Biology and Treatments (Μ.Α.S.CA.B.T.)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Reported Outcomes (PROs) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression-Free Survival | At 12 months from each patient's enrollment | Progression-free survival: Laboratory-confirmed disease progression or death, measured from study entry |
| Overall Survival | At 12 months from each patient's enrollment | Overall survival: Time to death, measured from study entry |
Countries
Greece
Outcome results
None listed