Cancer Patients With Outpatient TreatmentNCT06745401
Remote Monitoring of Cancer Patients With Outpatient Treatment
An observational study of Cancer Patients With Outpatient Treatment, run by Persei Vivarium at 1 site in Spain.
Trial summary
This project focuses on studying the use of digital platforms for monitoring, between medical visits, parameters such as toxicities and therapeutic adherence. The goal of this observational study is to know the degree of usability of the Caaring® digital platform in cancer patients undergoing outpatient oral… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cancer Patients With Outpatient Treatment
- How many people
- 34 participants
- Where
- 1 siteSpain
- Study dates
- 21 Nov 2024to 3 Mar 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Cancer Patients from the Hospital HM Sanchinarro diagnosed who meet the selection criteria and sign the informed consent will be included.
Who may be able to join
- Cancer patients with adjuvant or metastatic oncological treatment
- Cancer patients with oral oncological treatment
- Patients who are able to complete the study questionnaires
- Patients who are able to handle the application on a smart mobile phone.
- Informed consent is obtained from the patient.
Who cannot join
- Patients who will not be able to commit to carrying out the follow-ups or do not have adequate technological skills.
- Patients with inability to give adequately the informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
This project focuses on studying the use of digital platforms for monitoring, between medical visits, parameters such as toxicities and therapeutic adherence.
The goal of this observational study is to know the degree of usability of the Caaring® digital platform in cancer patients undergoing outpatient oral treatment. This will allow in the future to design comparative studies that demonstrate the advantages of using this application in the management of these patients.
Participants will fill out various questionnaires in the Caaring app related to their symptoms, adherence to treatment, quality of life and physical activity, among others.
- Keywords
- Remote patient monitoring, Cancer patients, outpatient treatment, Caaring, real-world data, DTx, patient-reported data, Digital Health, PROMs
What is being measured
The primary outcome is the main question the study is designed to answer.
Usability of Caaring® for the management of oncology patients in outpatient oral treatment
Percentage of patients with at least 80% of the data completed in the application, Percentage of patients with 100% of the data completed in the application and Percentage of completion per patient
Measured: Day 0 up to 3 months
Secondary outcomes (5)
Degree of completion of data relating to treatment adherence
The Degree of completion of therapeutic adherence by patients in Caaring application between visits is defined as the ratio between the questionnaires requested and completed.
Measured: Weekly up to 3 months
Degree of completion of data related to the toxicity of their treatment
The Degree of completion of toxicity of their treatments by patients in Caaring application between visits: Percentage of patient participation defined as data completed among requested data; Percentage of patients with at least 80% of the data completed; Percentage of patients with 100% of the data completed and Percentage of patients with at least 80% of the data completed by questionnaire
Measured: Weekly up to 3 months
Quality of the care process through impact on the patient's quality of life: WHOQOL
Changes in patient's quality of life scale WHOQOL (World Health Organization Quality of Life) scores at the end of the study compared to baseline. Values (0-100), a higher score reflects a higher health-related quality of life.
Measured: Day 0 and week 12
Quality of the care process through impact on the patient's quality of life: IPAQ
Changes in International Physical Activity Questionaire (IPAQ) scores at the end of the study compared to baseline. Values (46-100), a higher score reflects a higher Physical Activity
Measured: Day 0 and week 12
Patient workload
Evaluate the Patient workload through the percentage of patients who complete the study correctly by completing all questionnaires
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 posted20 Dec 2024
- Study start21 Nov 2024
- Primary completion3 Mar 2025
- Study completion3 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer Patients With Outpatient TreatmentStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 34 participants (actual)
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
- NCT06745401
- Sponsor's protocol ID
- PersV.Onco.DTx01
- Status last verified
- Jun 2025
- First submitted
- 17 Dec 2024
- Last updated
- 5 Jun 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 5 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remote Monitoring of Cancer Patients With Outpatient Treatment
- ClinicalTrials.gov ID
- NCT06745401
- Acronym / sponsor ID
- PersV.Onco.DTx01
- Keywords
- Remote patient monitoring, Cancer patients, outpatient treatment, Caaring, real-world data, DTx, patient-reported data, Digital Health
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Persei VivariumUniversity, hospital or other
- Collaborators
- Effice Servicios Para la Investigacion S.L.
- Study start
- 21 Nov 2024 (actual)
- Primary completion
- 3 Mar 2025 (actual)
- Study completion
- 3 Mar 2025 (actual)
- First posted
- 20 Dec 2024 (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.
This project focuses on studying the use of digital platforms for monitoring, between medical visits, parameters such as toxicities and therapeutic adherence.
The goal of this observational study is to know the degree of usability of the Caaring® digital platform in cancer patients undergoing outpatient oral treatment. This will allow in the future to design comparative studies that demonstrate the advantages of using this application in the management of these patients.
Participants will fill out various questionnaires in the Caaring app related to their symptoms, adherence to treatment, quality of life and physical activity, among others.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Cancer Patients from the Hospital HM Sanchinarro diagnosed who meet the selection criteria and sign the informed consent will be included.
Key inclusion criteria (5 listed)
- Cancer patients with adjuvant or metastatic oncological treatment
- Cancer patients with oral oncological treatment
- Patients who are able to complete the study questionnaires
- Patients who are able to handle the application on a smart mobile phone.
- Informed consent is obtained from the patient.
Key exclusion criteria (2 listed)
- Patients who will not be able to commit to carrying out the follow-ups or do not have adequate technological skills.
- Patients with inability to give adequately the informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Usability of Caaring® for the management of oncology patients in outpatient oral treatment
Time frame: Day 0 up to 3 months
Percentage of patients with at least 80% of the data completed in the application, Percentage of patients with 100% of the data completed in the application and Percentage of completion per patient
5 secondary outcomes
Degree of completion of data relating to treatment adherence
Time frame: Weekly up to 3 months
Degree of completion of data related to the toxicity of their treatment
Time frame: Weekly up to 3 months
Quality of the care process through impact on the patient's quality of life: WHOQOL
Time frame: Day 0 and week 12
Quality of the care process through impact on the patient's quality of life: IPAQ
Time frame: Day 0 and week 12
Patient workload
Time frame: Week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2025.
- Individual participant dataSharing planned: No
Related trials for Cancer Patients With Outpatient Treatment
RecruitingPhase 2
A Study of Elranatamab Outpatient Administration in Patients With Relapsed/Refractory Multiple Myeloma
Multiple Myeloma (MM), Multiple Myeloma Refractory
RecruitingObservational study
PACOME (PAtient Cancer Oral MEdication) Cohort of Patients Treated With Oral Anticancer Drugs Benefiting From Oncoral Multidisciplinary Monitoring in Real Life: Predictive Factors and Safety of Treatments
Cancer, Oncology
Recruiting
Determining the Effectiveness of Remote Monitoring of Cancer Patients With Oral Cancer Treatment Using Caaring® Software
Cancer
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer Patients With Outpatient Treatment, run by Persei Vivarium at 1 site 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 5 inclusion and 2 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: finished, as of the sponsor's last update on 5 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Usability of Caaring® for the management of oncology patients in outpatient oral treatment (time frame: Day 0 up to 3 months). 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 5 Jun 2025.