Clinical trial · Interventional
MargheRITA (Remote Intelligence for Therapeutic Adherence)
Evaluation of Performance and Safety of APP RITA in Increasing the Therapeutic Adherence of Onco-Hematological Patients - a Prospective Monocentric Pre-Market Study with a Historical Group of Comparison
NCT05260203CI-TRIAL-00082280MargheRITAcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
It is essential to improve clinical efficiency and management of hematological and oncological patients treated on an outpatient basis. The most promising operative way to achieve this result is the development of tele-oncology platforms, that allow not only a telemedicine visit, but also the patient support in the daily management of the disease and related disorders, as well as treatments and their complications. In this perspective, the RITA communication platform should be able to support the patient, the caregiver, the physician and the general practitioner in the management of the disease and its treatments.
Conditions
Conditions (14)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
| Amyloidosis | Amyloidosis | ONTOLOGY_EXACT | 0.98 |
| B-cell Non Hodgkin Lymphoma | B-Cell Non-Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.98 |
| Chronic Lymphocytic Leukemia | Chronic Lymphocytic Leukemia | ONTOLOGY_EXACT | 0.98 |
| Chronic Myeloid Leukemia | Chronic Myeloid Leukemia, BCR-ABL1 Positive | ALIAS | 0.90 |
| Chronic Myeloproliferative Disorder | Myeloproliferative Neoplasm | ALIAS | 0.90 |
| Hodgkin Lymphoma | Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| RITA (App) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- App RITA
- description
- The interventional study group will use the Device Rita, an application that allow the oncological and onco-hematological patients to receive and communicate information about the quality of life and about the treatment related adverse events, providing a support in the therapy management. The access to the app functionalities is granted when the physician habilitates the personal profile. The app can be also used from people designated from the patient as caregiver, who can view the data inserted by the patient and, if enabled, they can insert the data for the patient.
- interventionNames
- Device: RITA (App)
- type
- NO_INTERVENTION
- label
- Retrospective Historical
- description
- This clinical trial has no control intervention; on the other hand, the clinical outcomes of this treatment will be compared with the retrospective clinical data obtained from a historical group of comparison. The historic control used in this clinical trial is specifically selected to reflect the endpoints. According to a feasibility phase of this study, the information on the date of start and end of treatments is routinely collected in the medical records of patients, and for this reason, these data are potentially already available for the historical control group.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients who understand and voluntarily sign an informed consent form (ICF) prior to any study related procedures being conducted; * Patients who are ≥ 18 years old; * Patients who are diagnosed with a onco-hematologic disease, namely: Symptomatic Multiple Myeloma, Solitary Plasmocytoma, Amyloidosis, Chronic Myeloid Leukemia, Chronic Lymphocytic Leukemia, Lymphocytic Lymphoma, Hodgkin Lymphoma, B cells non-Hodgkin Lymphoma, T cells non-Hodgkin Lymphoma, Acute myeloid Leukemia, Myelodysplasia, Chronic Myeloproliferative Disorder; * Patients who receive a standard of care therapy for their disease, independently from the route of administration; * Patients in their first or subsequent line of therapy; * Patients at the beginning of the treatment, or during therapy; * Life expectancy \> 6 months. Exclusion Criteria: * Patients treated with radiotherapy only; * Presence of clinical conditions that will impair the adherence to the treatment (ie, concomitant tumor on treatment, severe neurologic disease, drug or alcohol abuse etc.); * Patient unable to use a smartphone and/or a computer (ie blindness, inability to use a smartphone or a computer etc.); * Major psychopathology or cognitive impairment likely in the judgment of the research staff to interfere with the participation or completion of the protocol; * Patient enrolled in another clinical trial.
References
Publications (11)
- BACKGROUNDSandstrom M, Wilen J, Oftedal G, Hansson Mild K. Mobile phone use and subjective symptoms. Comparison of symptoms experienced by users of analogue and digital mobile phones. Occup Med (Lond). 2001 Feb;51(1):25-35. doi: 10.1093/occmed/51.1.25. PMID 11235824
- BACKGROUNDOftedal G, Wilen J, Sandstrom M, Mild KH. Symptoms experienced in connection with mobile phone use. Occup Med (Lond). 2000 May;50(4):237-45. doi: 10.1093/occmed/50.4.237. PMID 10912374
- BACKGROUNDChia SE, Chia HP, Tan JS. Prevalence of headache among handheld cellular telephone users in Singapore: a community study. Environ Health Perspect. 2000 Nov;108(11):1059-62. doi: 10.1289/ehp.001081059. PMID 11102297
- BACKGROUNDKoivisto M, Haarala C, Krause CM, Revonsuo A, Laine M, Hamalainen H. GSM phone signal does not produce subjective symptoms. Bioelectromagnetics. 2001 Apr;22(3):212-5. doi: 10.1002/bem.41. PMID 11255218
- BACKGROUNDHocking B. Preliminary report: symptoms associated with mobile phone use. Occup Med (Lond). 1998 Sep;48(6):357-60. doi: 10.1093/occmed/48.6.357. PMID 10024730
- BACKGROUNDHietanen M, Hamalainen AM, Husman T. Hypersensitivity symptoms associated with exposure to cellular telephones: no causal link. Bioelectromagnetics. 2002 May;23(4):264-70. doi: 10.1002/bem.10016. PMID 11948605
- BACKGROUNDWilen J, Sandstrom M, Hansson Mild K. Subjective symptoms among mobile phone users--a consequence of absorption of radiofrequency fields? Bioelectromagnetics. 2003 Apr;24(3):152-9. doi: 10.1002/bem.10101. PMID 12669297
- BACKGROUNDKoivisto M, Revonsuo A, Krause C, Haarala C, Sillanmaki L, Laine M, Hamalainen H. Effects of 902 MHz electromagnetic field emitted by cellular telephones on response times in humans. Neuroreport. 2000 Feb 7;11(2):413-5. doi: 10.1097/00001756-200002070-00038.