CancerONCOCAARINGNCT06998888
Determining the Effectiveness of Remote Monitoring of Cancer Patients With Oral Cancer Treatment Using Caaring® Software
A study testing software Caaring (remote monitoring app) in people with Cancer, run by Persei Vivarium at 3 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- software Caaring (remote monitoring app)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 194 participants
- Where
- 3 sitesSpain
- Study dates
- 11 Apr 2025to Aug 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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."
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Spain3 sites, 3 recruiting
- Recruiting
Hospital Universitario HM Monteprincipe
Boadilla del Monte, Madrid, 28660
Jose Manuel Cervera-Grau, PhD, +34 919370000, jmcervera@hmhospitales.com
Jose Manuel Cervera-Grau, PhD
- Recruiting
Hospital Universitario HM Sanchinarro
Hortaleza, Madrid, 28050
Rosana Cajal, PhD, +34 919370000, rcajalm@gmail.com
Rosana Cajal, PhD
- Recruiting
Hospital Universitario HM Puerta del Sur
Móstoles, Madrid, 28938
Justo Ortega Anselmi, PhD, +34 919370000, jgortega@hmhospitales.com
Justo Ortega Anselmi, PhD
About this study
Official title: Determining the Effectiveness of Remote Monitoring of Cancer Patients Undergoing Outpatient 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.
Read more
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.
Read the detailed 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
- Conditions
- Cancer
- Being tested
- software Caaring (remote monitoring app)
- Keywords
- Caaring, Digital Care, Cancer, Remote patient monitoring, Online telemonitoring, DTx
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Online telemonitoring group (G_CAARING) | Active comparator | The monitoring and control of these patients will be carried out remotely through the Caaring® platform. Patients will connect to an APP on a mobile phone. They will have to complete the data and questionnaires related to the study variables. Receives: Device: software Caaring (remote monitoring app) |
| Control Group (G_Control) | No intervention | The data of these patients are collected prospectively from their routine medical visits for 12 weeks after inclusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of adherence to treatment prescribed for cancer
The Percentage of adherence to treatment prescribed for cancer will be calculed: Units minus unused units, multiplied by 100
Measured: 12 weeks
Secondary outcomes (4)
Percentage of patients with al least 80% of data completed
Percentage of patients with al least 80% of data completed in the application.
Measured: Week 12
Percentage of patients with 100% of data completed
Percentage of patients with 100% of data completed in the application
Measured: Week 12
Changes in the use of health resources
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.
Measured: Day 0 and Monthly up to 12 weeks
Patient satisfaction with the software Caaring
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.
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2025
- Study start11 Apr 2025
- Primary completionJul 2025 (estimated)
- Study completionAug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 194 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Persei Vivarium
- Sponsor type
- University, hospital or other
- Collaborators
- Effice Servicios Para la Investigacion S.L.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06998888
- Sponsor's protocol ID
- ONCOCAARING
- Acronym
- ONCOCAARING
- Status last verified
- May 2025
- First submitted
- 21 May 2025
- Last updated
- 31 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determining the Effectiveness of Remote Monitoring of Cancer Patients Undergoing Outpatient Oral Cancer Treatment Using Caaring® Software
- ClinicalTrials.gov ID
- NCT06998888
- Acronym / sponsor ID
- ONCOCAARING / ONCOCAARING
- Conditions
- Cancer
- Keywords
- Caaring, Digital Care, Cancer, Remote patient monitoring, Online telemonitoring, DTx
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 194 participants (estimated)
- Lead sponsor
- Persei VivariumUniversity, hospital or other
- Collaborators
- Effice Servicios Para la Investigacion S.L.
- Study start
- 11 Apr 2025 (actual)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Aug 2025 (estimated)
- First posted
- 31 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Online telemonitoring group (G_CAARING) | Active comparator | Device: software Caaring (remote monitoring app)The monitoring and control of these patients will be carried out remotely through the Caaring® platform. Patients will connect to an APP on a mobile phone. They will have to complete the data and questionnaires related to the study variables. |
| Control Group (G_Control) | No intervention | –The data of these patients are collected prospectively from their routine medical visits for 12 weeks after inclusion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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."
Key exclusion criteria (8 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| software Caaring (remote monitoring app)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. | Device | Online telemonitoring group (G_CAARING) |
Primary outcome
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
4 secondary outcomes
Percentage of patients with al least 80% of data completed
Time frame: Week 12
Percentage of patients with 100% of data completed
Time frame: Week 12
Changes in the use of health resources
Time frame: Day 0 and Monthly up to 12 weeks
Patient satisfaction with the software Caaring
Time frame: Week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing software Caaring (remote monitoring app) in people with Cancer, run by Persei Vivarium at 3 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Roberto Bravo (+34915004013, roberto.bravo@perseivivarium.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of adherence to treatment prescribed for cancer (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2025.