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

Last updated: May 21, 2025
Sponsor: Persei Vivarium
Overall Status: Active - Recruiting

Phase

N/A

Condition

Cancer

Treatment

software Caaring (remote monitoring app)

Clinical Study ID

NCT06998888
ONCOCAARING
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 withoutintravenous therapy.

  • Oncology patients undergoing active outpatient oral oncology treatment expectedwithin 12 weeks of inclusion.

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

  • Patients who do not meet the exclusion criteria.

Exclusion

Exclusion Criteria:

  • Patients with cognitive or sensory difficulties or insufficient command of Spanishlanguage that, in the opinion of the healthcare professional conducting therecruitment, makes it difficult to understand the questions posed in the surveys,scales, or instruments used in the study, provided they do not have a legalrepresentative capable of participating in the study.

  • Patients for whom it is anticipated that follow-up will not be possible due to achange of residence.

  • Patients who are participating in any other clinical trial or experimental study atthe time of recruitment. Participation in observational studies will not be anexclusion criteria.

  • Patients whose primary diagnosis is a mental illness or another poorly controlledmedical condition.

  • Terminally ill patients and/or those receiving palliative care according to thecriteria of SECPAL (Spanish Society of Palliative Care).

  • Institutionalized patients.

  • Patients who, according to the recruiting professional's assessment, are notconsidered eligible for inclusion because they are undergoing specific follow-upcare in other units (hemodialysis, transplants, etc.) requiring mandatory hospitalvisits less frequently than once every two months.

  • Patients who do not demonstrate sufficient technological skills to use a smartphonethrough the "technological skills questionnaire."

Study Design

Total Participants: 194
Treatment Group(s): 1
Primary Treatment: software Caaring (remote monitoring app)
Phase:
Study Start date:
April 11, 2025
Estimated Completion Date:
August 31, 2025

Study 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

Connect with a study center

  • Hospital Universitario HM Monteprincipe

    Boadilla del Monte, Madrid 28660
    Spain

    Active - Recruiting

  • Hospital Universitario HM Sanchinarro

    Hortaleza, Madrid 28050
    Spain

    Active - Recruiting

  • Hospital Universitario HM Puerta del Sur

    Mostoles, Madrid 28938
    Spain

    Active - Recruiting

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