Multiple Myeloma Clinical Trial
— MargheRITAOfficial title:
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
NCT number | NCT05260203 |
Other study ID # | CO-09-A02 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | June 4, 2022 |
Est. completion date | January 16, 2023 |
Verified date | February 2023 |
Source | Advice Pharma Group srl |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 124 |
Est. completion date | January 16, 2023 |
Est. primary completion date | January 16, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Italy | ASST Santi Paolo e Carlo - SSD Ematologia - Neoplasie Ematologiche P.O. San Carlo | Milano |
Lead Sponsor | Collaborator |
---|---|
Advice Pharma Group srl |
Italy,
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Minor complications | Number of AE/minor complications not requiring assistance notified by the patient during the study period, through the app RITA and directly during the clinical visit, compared to the historical control group | Daily/ Assessment at each month for three months | |
Other | Safety Outcome - Adverse events | Occurrence of individual adverse events (%) reported during the follow up period, during the use session, and during intervals between one use session and the following Occurrence of device adverse events (%) during the use session | Daily/ Assessment at each month for three months | |
Primary | Evaluating changes in actual dose intensity | The primary outcome is defined as the comparison between the proportion of patients with at least 20% of increase in the relative dose intensity (defined as the ratio of delivered dose intensity to the prescribed referenced dose intensity, expressed as a percentage) of anticancer treatment during the study period in the two arms (i.e., intervention and historical group). The actual delivered dose intensity will be evaluated at each follow up visit through the drug accountability performed onsite. | Daily/ Assessment at each month for three months | |
Secondary | Number of grade 3-4 adverse events | Incidence of grade 3-4 treatment-related adverse events | Daily/ Assessment at each month for three months | |
Secondary | Number of visits to the Emergency Room | Number of visits to the emergency room for complications not requiring hospitalization Number of visits to the emergency room for severe complications requiring hospitalization | Daily/ Assessment at each month for three months | |
Secondary | Number of days in hospital | Average number of days in hospital stay | Daily/ Assessment at each month for three months | |
Secondary | Quality of life change - Questionnaire EQ-5D-5L | Evaluation of changes in the quality of life perceived by the patients using the validated questionnaire for data collection EQ-5D-5L | Daily/ Assessment at each month for three months | |
Secondary | Quality of life change - Questionnaire EORTC QLQC30 | Evaluation of changes in the quality of life perceived by the cancer patients using the validated questionnaire for data collection EORTC QLQC30 | Daily/ Assessment at each month for three months | |
Secondary | RITA APP Experience evaluation | User Experience in using the RITA APP, through the questions proposed by the app about the user satisfaction | Daily/ Assessment at each month for three months |
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