Determining the Effectiveness of Remote Monitoring of Cancer Patients With Oral Cancer Treatment Using Caaring® Software

NCT06998888 | Recruiting

• 1 other identifier: ONCOCAARING
• Study Type: interventional
• Target: 194
• Locations: 1 country
• Sites: 3

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.

Conditions

Cancer

Keywords

Caaring; Digital Care; Cancer; Remote patient monitoring; Online telemonitoring; DTx

Outcome Measures

Primary Outcomes (1)

• Percentage of adherence to treatment prescribed for cancer

  The Percentage of adherence to treatment prescribed for cancer will be calculed: Units minus unused units, multiplied by 100

  12 weeks

Secondary Outcomes (4)

• Percentage of patients with al least 80% of data completed

  Week 12

• Percentage of patients with 100% of data completed

  Week 12

• Changes in the use of health resources

  Day 0 and Monthly up to 12 weeks

• Patient satisfaction with the software Caaring

  Week 12

Study Arms (2)

Online telemonitoring group (G_CAARING)

ACTIVE COMPARATOR

The monitoring and control of these patients will be carried out remotely through the Caaring® platform. Patients will connect to an APP on a mobile phone. They will have to complete the data and questionnaires related to the study variables.

Device: software Caaring (remote monitoring app)

Control Group (G_Control)

NO INTERVENTION

The data of these patients are collected prospectively from their routine medical visits for 12 weeks after inclusion

Interventions

software Caaring (remote monitoring app) DEVICE

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.

Online telemonitoring group (G_CAARING)

Eligibility Criteria

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

You may qualify if:

• 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.
• Patients who must demonstrate sufficient technological skills to operate a smartphone through the "technological skills questionnaire."

You may not qualify if:

• Patients with cognitive or sensory difficulties or insufficient command of Spanish language that, in the opinion of the healthcare professional conducting the recruitment, makes it difficult to understand the questions posed in the surveys, scales, or instruments used in the study, provided they do not have a legal representative capable of participating in the study.
• Patients for whom it is anticipated that follow-up will not be possible due to a change of residence.
• Patients whose primary diagnosis is a mental illness or another poorly controlled medical condition.
• Terminally ill patients and/or those receiving palliative care according to the criteria of SECPAL (Spanish Society of Palliative Care).
• Institutionalized patients.
• Patients who do not demonstrate sufficient technological skills to use a smartphone through the "technological skills questionnaire."

Sponsors & Collaborators

• Persei Vivarium: lead
• Effice Servicios Para la Investigacion S.L.: collaborator

Study Sites (3)

Hospital Universitario HM Monteprincipe

Boadilla del Monte, Madrid, 28660, Spain

RECRUITING

Hospital Universitario HM Sanchinarro

Hortaleza, Madrid, 28050, Spain

RECRUITING

Hospital Universitario HM Puerta del Sur

Móstoles, Madrid, 28938, Spain

RECRUITING

MeSH Terms

Conditions

Neoplasms

Central Study Contacts

Roberto Bravo

CONTACT

+34915004013; roberto.bravo@perseivivarium.com

Study Design

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

Study Record Dates

• First Submitted: May 21, 2025
• First Posted: May 31, 2025
• Study Start: April 11, 2025
• Primary Completion: July 1, 2025
• Study Completion: August 1, 2025
• Last Updated: May 31, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (3)