Differential Effects of a Telemonitoring Platform in the Development of Chemotherapy-Associated Toxicity: A Randomised Trial

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.