Effects of Telemonitoring in Quality of Life Amongst Cancer Patients

Trial Title: Effects of Telemonitoring in Quality of Life Amongst Cancer Patients

NCT ID: NCT06086990

Condition: Cancer
Telemonitoring
Telemedicine
Symptoms and Signs
Quality of Life

Conditions: Keywords:
Telemonitoring
Internet
Web-based applications
Quality of Life
Smartphones
Cancer

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Intervention model description: Participants will be randomly allocated in a 1:1 fashion to receive the smartphone application or usual follow-up care.

Primary purpose: Treatment

Masking: Triple (Care Provider, Investigator, Outcomes Assessor)

Masking description: Outcome assessors, investigators and analysts will be kept unaware of treatment allocation. However, due to the characteristics of the intervention, it is not possible to mask participants.

Intervention:

Intervention type: Device
Intervention name: Contigo Application
Description: Contigo, a smartphone app, focuses on two main goals: monitoring cancer patients for early signs of drug toxicity and offering educational content to empower them in managing clinical challenges linked to their diagnosis and treatment. Monitoring involves patients inputting experiences via oncology-related questionnaires, with weekly checks for chemotherapy toxicity using a validated questionnaire (PRO-CTCAE). Severe cases trigger alerts, while milder ones receive educational guidance. Data collected is shared with healthcare providers. Educational content, backed by scientific evidence and expert collaboration, covers cancer-specific topics and healthcare processes to enhance patients' self-awareness and self-care practices.
Arm group label: Telemonitoring Platform

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.

Criteria for eligibility:
Criteria:
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.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: UC Christus Cancer Centre

Address:
City: Santiago
Country: Chile

Status: Recruiting

Contact:
Last name: Bruno Nervi, MD

Phone: 23546900

Phone ext: +56
Email: bnervi@uc.cl

Start date: April 1, 2024

Completion date: March 2025

Lead sponsor:
Agency: Universidad Nacional Andres Bello
Agency class: Other

Collaborator:
Agency: Centro para la Prevención y Control del Cáncer (CECAN), Santiago, Chile
Agency class: Other

Source: Universidad Nacional Andres Bello

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06086990
https://cecan.cl/
https://www.ucchristus.cl/especialidades-y-servicios/especialidades/cancer-uc