Cancer
Conditions
Keywords
Caaring, Digital Care, Cancer, Remote patient monitoring, Online telemonitoring, DTx
Brief summary
The goal of this clinical trial investigation with device is to determinate the efficacy of the remote monitoring in cancer patients with a software called Caaring® a través del cumplimento terapéutico y de dosis. The main question it aims to answer is if the development of a self-management platform (Caaring®) empowers cancer patients throughout their illness, reducing the number of in-person and telephone visits assisted by specialized medical and nursing staff. For this, researchers will compare the assessments between the two groups. This is a randomized study with two arms. Online telemonitoring group: The follow-up of these patients will be carried out prospectively remotely through the Caaring® platform. And Prospective Control group: The data of these patients are collected prospectively for their routine medical visits for 12 weeks after their inclusion. Caaring group patients must have sufficient technological skills to use a smartphone.
Detailed description
This is a longitudinal, comparative non-inferiority, multicenter, with 2 arms Medical Device Clinical Trial. The protocol and informed consent documents have been reviewed and approved by the hospital human subjects reviewboard and the study will be performed in accordance with the Declaration of Helsinki
Interventions
Caaring is an electronic data collection notebook that allows patients to confidentially fill out data/ questionnaires on their mobile phone and report them through an application that will be installed on the patient's mobile phone. Besides, This group (G\_CAARING) will receive educational and prevention recommendations relative to cancer.
Sponsors
Effice Servicios Para la Investigacion S.L.
Persei Vivarium
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients who provide informed consent. * Age ≥18 years. * Oncology patients undergoing active outpatient oral therapy with: capecitabine, cyclin inhibitors, hormonal therapies, TKI inhibitors, monotherapy with or without intravenous therapy. * Oncology patients undergoing active outpatient oral oncology treatment expected within 12 weeks of inclusion. * Patients who must demonstrate sufficient technological skills to operate a smartphone through the technological skills questionnaire. * Patients who do not meet the
Exclusion criteria
.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of adherence to treatment prescribed for cancer | 12 weeks | The Percentage of adherence to treatment prescribed for cancer will be calculed: Units minus unused units, multiplied by 100 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of patients with al least 80% of data completed | Week 12 | Percentage of patients with al least 80% of data completed in the application. |
| Percentage of patients with 100% of data completed | Week 12 | Percentage of patients with 100% of data completed in the application |
| Changes in the use of health resources | Day 0 and Monthly up to 12 weeks | Change in patient´s use of health resources scores al basal monthly and at the end of the study compared to baseline: Number of visits to specialist (e.g. oncology, primary care etc), number of emergency room vistis or number of new hospitalizations. |
| Patient satisfaction with the software Caaring | Week 12 | The patient satisfaction will be measured through a specific satisfaction questionnaire created for this purpose. Values: 3-15, a higher score refletcs greater satisfaction with software care. |
Countries
Spain
Contacts
Primary ContactRoberto Bravo
Outcome results
None listed