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NCT Number: NCT06998888

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

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.

Recruiting

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Universitario HM Monteprincipe, Boadilla del Monte, Madrid, Spain

Loading trial locations.

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Exclusion criteria

  • 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 who are participating in any other clinical trial or experimental study at the time of recruitment. Participation in observational studies will not be an exclusion criteria.
  • 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, according to the recruiting professional's assessment, are not considered eligible for inclusion because they are undergoing specific follow-up care in other units (hemodialysis, transplants, etc.) requiring mandatory hospital visits less frequently than once every two months.
  • Patients who do not demonstrate sufficient technological skills to use a smartphone through the "technological skills questionnaire."

Treatment and study plan

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.

Primary outcomes

  1. Percentage of adherence to treatment prescribed for cancer

    Time frame: 12 weeks

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

Secondary outcomes

  1. Percentage of patients with al least 80% of data completed

    Time frame: Week 12

    Percentage of patients with al least 80% of data completed in the application.

  2. Percentage of patients with 100% of data completed

    Time frame: Week 12

    Percentage of patients with 100% of data completed in the application

  3. Changes in the use of health resources

    Time frame: 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.

  4. Patient satisfaction with the software Caaring

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Roberto Bravo

CONTACT

[email protected]

+34915004013

Sponsors and collaborators

Lead sponsor

Persei Vivarium

Other

Collaborators

  • Effice Servicios Para la Investigacion S.L.

Registry information

Official study title

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

Acronym: ONCOCAARING

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
May 31, 2025
Registry last updated
May 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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