Telemonitoring Platforms and Chemotherapy-Associated Toxicity (DETECT)

Universidad Nacional Andres Bello

Status: Enrolling

Conditions: Chemotherapeutic Agent Toxicity; Cancer

Treatments: Device: Contigo Application

Study type: Interventional

Funder types: Other

Identifiers

NCT06077123

UNAB-004

Details and patient eligibility

About

The primary objective of this trial is to evaluate the impact of a telemonitoring platform on patient satisfaction with care amongst adult cancer patients receiving chemotherapy. The key questions it seeks to address revolve around the potential improvements in both quality of life and satisfaction with healthcare. Participants in the trial will be provided with a specialized application developed by a team of experienced oncology professionals. Their quality of life and healthcare experience will be compared with that of the control group, who will only receive the standard in-person check-ups established by their healthcare team.

Full description

This protocol describes a randomized parallel-group clinical trial among recently diagnosed patients with solid carcinomas preparing for curative intent chemotherapy at Hospital Sótero del Río and UC-Christus Health Network centers. Eligible adult patients (>18 years) diagnosed with lung, gastric, gallbladder, colon, breast, or cervical carcinoma, scheduled for outpatient curative intent chemotherapy within UC-Christus Health Network or Hospital Sotero del Rio from November 2023 to July 2024, proficient in Spanish, and possessing a smartphone (iOS® or Android®) will be recruited. Exclusions include those undergoing concomitant radiotherapy, sensory impairments hindering app use, cognitive or psychiatric issues, and unwillingness to participate. Participants will be randomized 1:1 to receive either the Contigo smartphone application or standard care. Contigo aims to monitor chemotherapy toxicity symptoms and deliver cancer-related educational content. The application includes modules addressing cancer care, self-perception of health, patient experiences, frequently asked questions, community resources, and scheduling. Information collected by the app will be available to healthcare providers. Patients will receive the app for free and undergo training on its usage. Weekly toxicity assessments using Patient-Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) will be conducted. The control group will receive standard in-person care. The primary outcome is patient experience during chemotherapy, measured using the OUT-PATSAT-35 questionnaire three months after randomization. Secondary outcomes include severe chemotherapy-associated toxicity, quality of life, and user satisfaction with the application. A sample size of 80 participants (40 per group) was calculated. Descriptive analysis will utilize means, standard deviation, frequencies, and percentages. Inferential analysis will involve t-tests, Mann-Whitney U tests, Fisher's Exact Test, and Kaplan-Meier survival curves. All analyses will adhere to intention-to-treat principles and use Stata v.16.0® software. No subgroup analyses have been programmed.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult patients (>18 years)
• Histologically confirmed diagnosis of lung, gastric, gallbladder, colon, breast, or cervical carcinoma in any of its forms and stages
• Initiating an outpatient curative intent chemotherapy regimen within the facilities of UC-Christus Health Network or Hospital Sotero del Río during the months of November 2023 to July 2024
• Proficient in the Spanish language
• Possess a smartphone, regardless of the native operating system (iOS® or Android®)

Exclusion criteria

• Individuals undergoing concomitant radiotherapy
• Those with any form of sensory impairment hindering the use of the application
• Those with cognitive impairment or psychiatric pathology preventing the use of the application
• Those who do not wish to participate in the study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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80 participants in 2 patient groups

Telemonitoring Platform

Experimental group

Description:

Patients allocated to the active intervention group will receive a smartphone application called Contigo. This tool aims to detect signs and symptoms of oncology drug toxicity and delivering educational content that enables the patient to have tools to address common clinical situations associated with the diagnosis and treatment of their disease.

Treatment:

Device: Contigo Application

Traditional Follow-Up

No Intervention group

Description:

Those assigned to the traditional follow-up group will receive standard care and in-person check-ups as determined by their attending physician.