Effects of Telemonitoring in Quality of Life Amongst Cancer Patients

Not Applicable

Recruiting

• Conditions: Telemonitoring; Telemedicine; Cancer; Symptoms and Signs; Quality of Life
• Interventions: Device: Contigo Application

• Registration Number: NCT06086990
• Lead Sponsor: Universidad Nacional Andres Bello

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2023-10-10
• Study First Submitted QC: 2023-10-10
• Study First Posted: 2023-10-17
• Status Verified: 2024-04
• Study Start: 2024-04-01
• Last Update Submitted: 2024-04-05
• Last Update Posted: 2024-04-08
• Primary Completion: 2024-12
• Study Completion: 2025-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Telemonitoring Platform	Contigo Application	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.

Primary Outcome Measures

Name	Time	Method
Quality of Life Scores	30, 60 and 90 days after randomization.	Quality of Life as assessed by the EuroQol 5 Dimension (EQ-5D) questionnaire. The index score ranges from 0 to 1, with higher values indicating an overall better quality of life.

Secondary Outcome Measures

Name	Time	Method
Adherence to medical appointments	90 days after randomization.	Adherence to in-person medical appointments, as established by the attending physician of each participant. This outcome will be expressed as the proportion of visits attended by each patient.
Development of Symptoms of Depression	30, 60 and 90 days after randomization.	Development of symptoms of depression as evaluated by the Patient Health Questionnaire 9 (PHQ-9) scale. Scores can range from 0 to 27, with higher scores increasing the probability of depression.

Trial Locations

Locations (1)

UC Christus Cancer Centre; 🇨🇱 Santiago, Chile