Determining the Effectiveness of Remote Monitoring of Cancer Patients With Oral Cancer Treatment Using Caaring® Software

Official title

Determining the Effectiveness of Remote Monitoring of Cancer Patients Undergoing Outpatient Oral Cancer Treatment Using Caaring® Software

Overview

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

Interventions

• Device 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.

Primary outcome measures

• Percentage of adherence to treatment prescribed for cancer [Time frame: 12 weeks]

Secondary outcome measures (4)

• 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]

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."

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Other

Study locations

Spain · 3 centers

• Hospital Universitario HM Monteprincipe — Boadilla del Monte
• Hospital Universitario HM Sanchinarro — Hortaleza
• Hospital Universitario HM Puerta del Sur — Móstoles

Identifiers

NCT: NCT06998888 · ONCOCAARING

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗