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| Name | Class |
|---|---|
| Μedical Association for the Study of Cancer Biology and Treatments (Μ.Α.S.CA.B.T.) | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Digital support | Behavioral | Personalized educational and supportive material, based on each patients' adverse events reported as PROs, delivered via the online platform. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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:
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. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival | Progression-free survival: Laboratory-confirmed disease progression or death, measured from study entry | At 12 months from each patient's enrollment |
| Overall Survival |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alexandra General Hospital | Recruiting | Athens | 11528 | Greece |
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| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
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Overall survival: Time to death, measured from study entry
| At 12 months from each patient's enrollment |
| D014652 |
| Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |