RecruitingNot ApplicableNCT06077123

Telemonitoring Platforms and Chemotherapy-Associated Toxicity

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


Sponsor

Universidad Nacional Andres Bello

Enrollment

80 participants

Start Date

Apr 1, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria5

  • 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 Criteria4

  • 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

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Interventions

DEVICEContigo Application

Contigo, a smartphone application, aims to achieve two main objectives: monitoring cancer patients for early detection of oncology drug toxicity signs and providing educational content to empower patients in handling clinical challenges tied to their diagnosis and treatment. Monitoring involves modules and sub-modules where patients input experiences through oncology-related questionnaires. Weekly checks for chemotherapy toxicity-associated symptoms use a validated questionnaire (PRO-CTCAE). Severe toxicity triggers immediate alerts, while milder cases receive educational guidance. Data collected is shared with healthcare providers. Educational health content has been created by professionals, encompassing cancer-specific topics, healthcare processes, administration, health coverage, self-awareness, and self-care practices. The content is based on scientific evidence, official reports, and group sessions involving healthcare professionals and cancer patients.


Locations(2)

Centro del Cáncer, Pontificia Universidad Católica de Chile

Santiago, Chile

Complejo Asistencial Dr. Sotero del Río

Santiago, Chile

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NCT06077123


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