Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06998888

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

Led by Persei Vivarium · Updated on 2025-05-31

194

Participants Needed

3

Research Sites

16 weeks

Total Duration

On this page

Sponsors

P

Persei Vivarium

Lead Sponsor

E

Effice Servicios Para la Investigacion S.L.

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients who provide informed consent.
  • Age 18 years or older.
  • Oncology patients undergoing active outpatient oral therapy with capecitabine, cyclin inhibitors, hormonal therapies, TKI inhibitors, or monotherapy with or without intravenous therapy.
  • Oncology patients expected to continue active outpatient oral oncology treatment for at least 12 weeks after inclusion.
  • Patients who demonstrate sufficient technological skills to use a smartphone.
  • Patients who do not meet exclusion criteria.
Not Eligible

You will not qualify if you...

  • Patients with cognitive or sensory difficulties or insufficient command of Spanish language that impair understanding of study questionnaires, unless they have a legal representative.
  • Patients unlikely to complete follow-up due to change of residence.
  • Patients participating in other clinical trials or experimental studies at the time of recruitment (observational studies allowed).
  • Patients with primary diagnosis of mental illness or poorly controlled medical condition.
  • Terminally ill patients or those receiving palliative care as defined by SECPAL.
  • Institutionalized patients.
  • Patients receiving specific follow-up care in other units requiring hospital visits less often than every two months (e.g., hemodialysis, transplants).
  • Patients who do not demonstrate sufficient technological skills to use a smartphone.

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 3 locations

1

Hospital Universitario HM Monteprincipe

Boadilla del Monte, Madrid, Spain, 28660

Actively Recruiting

2

Hospital Universitario HM Sanchinarro

Hortaleza, Madrid, Spain, 28050

Actively Recruiting

3

Hospital Universitario HM Puerta del Sur

Móstoles, Madrid, Spain, 28938

Actively Recruiting

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Research Team

R

Roberto Bravo

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

2

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