NCT06998888 Determining the Effectiveness of Remote Monitoring of Cancer Patients With Oral Cancer Treatment Using Caaring® Software
| NCT ID | NCT06998888 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Persei Vivarium |
| Condition | Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 194 participants |
| Start Date | 2025-04-11 |
| Primary Completion | 2025-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 194 participants in total. It began in 2025-04-11 with a primary completion date of 2025-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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."
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06998888 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06998888 currently recruiting?
Yes, NCT06998888 is actively recruiting participants. Contact the research team at roberto.bravo@perseivivarium.com for enrollment information.
Where is the NCT06998888 trial being conducted?
This trial is being conducted at Boadilla del Monte, Spain, Hortaleza, Spain, Móstoles, Spain.
Who is sponsoring the NCT06998888 clinical trial?
NCT06998888 is sponsored by Persei Vivarium. The trial plans to enroll 194 participants.
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