MargheRITA (Remote Intelligence for Therapeutic Adherence)

NCT05260203 | Completed

• 1 other identifier: CO-09-A02
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

Brief Summary

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

Multiple Myeloma; Solitary Plasmacytoma; Amyloidosis; Chronic Myeloid Leukemia; Chronic Lymphocytic Leukemia; T Cell Non-Hodgkin Lymphoma; Lymphocytic Lymphoma; Hodgkin Lymphoma; B-cell Non Hodgkin Lymphoma; Acute Myeloid Leukemia; Myelodysplasia; Chronic Myeloproliferative Disorder; Treatment Adherence; Treatment Adherence and Compliance

Keywords

Digital Therapeutics; Digital Medicine; Oncologic treatment; Hematologic treatment; Adherence; Software; Software Medical Device; Quality of life; Digital Therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Number of grade 3-4 adverse events

  Daily/ Assessment at each month for three months

• Number of visits to the Emergency Room

  Daily/ Assessment at each month for three months

• Number of days in hospital

  Daily/ Assessment at each month for three months

• Quality of life change - Questionnaire EQ-5D-5L

  Daily/ Assessment at each month for three months

• Quality of life change - Questionnaire EORTC QLQC30

  Daily/ Assessment at each month for three months

Other Outcomes (2)

• Minor complications

  Daily/ Assessment at each month for three months

• Safety Outcome - Adverse events

  Daily/ Assessment at each month for three months

Study Arms (2)

App RITA

EXPERIMENTAL

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.

Device: RITA (App)

Retrospective Historical

NO INTERVENTION

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.

Interventions

RITA (App) DEVICE

The RITA "Remote Intelligence for Therapeutic Adherence" application was designed, on the doctor's side, as a support for the management of the onco-hematological patient and, on the patient's side, as a first aid tool for the management of the most common problems, as well as an efficient and "non-invasive" means of communication with the doctor. The system also allows the caregiver and general practitioner to be included in the communication group. The added value of the app consists in improving the relationship between the patient and the doctor, creating an effective communication channel, increasing the safety the patient has when facing his difficult path, reducing the number of visits to the facility and, in general, making those visits more efficient, thus creating savings both in terms of time and resources.

App RITA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Advice Pharma Group srl: lead

Study Sites (1)

ASST Santi Paolo e Carlo - SSD Ematologia - Neoplasie Ematologiche P.O. San Carlo

Milan, Milano, 20153, Italy

Location

Related Publications (10)

• Sandstrom 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 BACKGROUND

• Oftedal 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 BACKGROUND

• Chia 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 BACKGROUND

• Koivisto 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 BACKGROUND

• Hocking 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 BACKGROUND

• Hietanen 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 BACKGROUND

• Wilen 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 BACKGROUND

• Koivisto 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.

  PMID: 10674497 BACKGROUND

• Oftedal G, Straume A, Johnsson A, Stovner LJ. Mobile phone headache: a double blind, sham-controlled provocation study. Cephalalgia. 2007 May;27(5):447-55. doi: 10.1111/j.1468-2982.2007.01336.x. Epub 2007 Mar 14.

  PMID: 17359515 BACKGROUND

• Rubin GJ, Hahn G, Everitt BS, Cleare AJ, Wessely S. Are some people sensitive to mobile phone signals? Within participants double blind randomised provocation study. BMJ. 2006 Apr 15;332(7546):886-91. doi: 10.1136/bmj.38765.519850.55. Epub 2006 Mar 6.

  PMID: 16520326 BACKGROUND

MeSH Terms

Conditions

Multiple Myeloma; Neoplasms, Plasma Cell; Amyloidosis; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Leukemia, Lymphocytic, Chronic, B-Cell; Lymphoma, T-Cell; Hodgkin Disease; Lymphoma, B-Cell; Leukemia, Myeloid, Acute; Anemia, Refractory, with Excess of Blasts; Myeloproliferative Disorders; Treatment Adherence and Compliance

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases; Leukemia, Myeloid; Leukemia; Bone Marrow Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Leukemia, B-Cell; Leukemia, Lymphoid; Lymphatic Diseases; Lymphoma, Non-Hodgkin; Lymphoma; Anemia, Refractory; Anemia; Myelodysplastic Syndromes; Health Behavior; Behavior

Study Officials

• Alessandro Flavio Ferri

  Advice Pharma Group S.r.l.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a prospective, interventional, confirmatory investigation, pre-market study, with a historical group of comparison

Study Record Dates

• First Submitted: December 30, 2021
• First Posted: March 2, 2022
• Study Start: June 4, 2022
• Primary Completion: January 16, 2023
• Study Completion: January 16, 2023
• Last Updated: November 6, 2024

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)