Effects of Telemonitoring in Quality of Life Amongst Cancer Patients (EQUALITE)

Universidad Nacional Andres Bello

Status: Enrolling

Conditions: Quality of Life; Symptoms and Signs; Telemonitoring; Cancer; Telemedicine

Treatments: Device: Contigo Application

Study type: Interventional

Funder types: Other

Identifiers

NCT06086990

UNAB-005

Details and patient eligibility

About

This interventional study aims to explore the potential of a smartphone app, Contigo, in enhancing the quality of life for patients with various cancers compared to standard care. The investigators will asses effects on quality of life, depressive symptoms, and appointment adherence.

Full description

The primary objective of this study is to determine if utilizing a smartphone app for disease monitoring improves the self-reported quality of life using validated questionnaires in patients with diverse solid cancers compared to standard care. Secondary objectives focused on evaluating its impact on depressive symptoms and assessing adherence to in-person appointments. This study involves a randomized trial among patients recently diagnosed with specific forms of cancer and undergoing curative treatment at the UC Christus Cancer Center. The eligible participants, 80 adults with recent histologically confirmed cancer diagnoses, will be randomized to receive either the smartphone application (Contigo) or standard educational care. Randomization will be performed independently using an allocation sequence that will be kept concealed from clinical investigators. Contigo offers two primary functions: monitoring cancer patients and delivering educational content to aid patients in dealing with common clinical situations related to their disease. The study will assess outcomes such as quality of life changes, depressive symptom development, and adherence to in-person appointments. All analyses will be undertaken under the intention to treat principle by a statistician unaware of treatment allocation.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult patients (>18 years old).
• Recent histologically confirmed diagnosis (within the last 3 months) of bronchogenic, breast, gallbladder, gastric, colorectal, or prostate cancer in any of its forms.
• Awaiting initiation of curative intent treatment for the disease using any modality (radiation therapy, chemotherapy, immunotherapy, etc.) at the UC-Christus Cancer Center.
• Possession of a smartphone, regardless of its native operating system (iOS® or Android®).
• Willingness to sign an informed consent form to participate in the study.

Exclusion criteria

• Any form of sensory impairment preventing app usage.
• Cognitive impairment.
• Psychiatric pathology hindering app usage.
• Unwillingness to participate in the study.
• Concurrent participation in another clinical trial addressing healthcare technologies.

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 assigned to the active intervention group will have access to a smartphone application named "Contigo." This application is designed to identify signs and symptoms of oncology drug toxicity while providing educational content. It equips patients with the necessary tools to manage typical clinical situations associated with the diagnosis and treatment of their disease.

Treatment:

Device: Contigo Application

Traditional Follow-Up

No Intervention group

Description:

Individuals designated to the traditional follow-up group will undergo standard care, including in-person check-ups as determined by their attending physician.