Remote monitoring with Caaring for people taking oral cancer medicines
Determining the Effectiveness of Remote Monitoring of Cancer Patients Undergoing Outpatient Oral Cancer Treatment Using Caaring® Software
This study will test whether using the Caaring smartphone platform to remotely monitor adults on outpatient oral cancer treatments reduces in-person and phone visits and supports treatment adherence.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 194 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Persei Vivarium Academic / other |
| Locations | 3 sites (Boadilla del Monte, Madrid and 2 other locations) |
| Trial ID | NCT06998888 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults (≥18) with cancer receiving outpatient oral anticancer therapies within the next 12 weeks who speak Spanish and can operate a smartphone are the ideal candidates.
Not a fit: Patients without adequate smartphone skills, with cognitive or sensory impairments that prevent completing digital surveys, or who cannot communicate in Spanish are unlikely to benefit from this remote-monitoring approach.
Why it matters
Potential benefit: If successful, the platform could let patients manage symptoms at home, reduce clinic and phone visits, and support adherence to oral cancer treatments.
How similar studies have performed: Previous remote monitoring programs in oncology have shown promising reductions in clinic visits and improved symptom control, though results vary by platform and cancer type.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Boadilla del Monte, Madrid and 2 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.