Digital Support for Multiple Myeloma Quality of Life
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorCareAcross
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult patients with newly diagnosed or relapsed/refractory multiple myeloma
Patients that are able to use the digital platform/application
Disqualifiers
Patients that are not able to use the digital platform/application
Trial design
Design model
Parallel
Treatments tested in this trial
Digital support
BehavioralPersonalized educational and supportive material, based on each patients' adverse events reported as PROs, delivered via the online platform.
Treatment groups
108 Participants
are divided into 2 treatment groupsGroup A: Arm 1 - ExperimentalExperimental treatment 1 intervention
Group B: Arm 2 - ControlNo intervention 0 interventions
Trial outcomes
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.
Time frame
From enrollment, until study completion, average 1 year.Secondary outcomes
1
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 enrollment2
Overall Survival
Overall survival: Time to death, measured from study entry
Time frame
At 12 months from each patient's enrollmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
CareAcross
Lead sponsor
Μedical Association for the Study of Cancer Biology and Treatments (Μ.Α.S.CA.B.T.)
Collaborator
Source ClinicalTrials.gov