Remote monitoring with Caaring for people taking oral cancer medicines

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, multicenter, non-inferiority study compares remote follow-up using the Caaring® self-management platform with routine in-person care for adults receiving outpatient oral cancer therapies. Participants are randomized to 12 weeks of prospective telemonitoring via the Caaring app or to standard prospective follow-up with routine clinic visits. Key outcomes include number of in-person and telephone visits, treatment adherence and dosing, and patient-reported symptoms collected through the platform. Patients must be ≥18, Spanish-speaking, and demonstrate sufficient smartphone skills to use the app.

Why it matters

Who can join: the full rules

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."

Where it's running

• Hospital Universitario HM Monteprincipe
  Boadilla del Monte, Madrid, Spain Recruiting
• Hospital Universitario HM Sanchinarro
  Hortaleza, Madrid, Spain Recruiting
• Hospital Universitario HM Puerta del Sur
  Móstoles, Madrid, Spain Recruiting

Study contacts

• Study coordinator: Roberto Bravo
• Email: roberto.bravo@perseivivarium.com
• Phone: +34915004013

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.