Effects of Telemonitoring in Quality of Life Amongst Cancer Patients

NCT06086990 | Recruiting

• 1 other identifier: UNAB-005
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Telemonitoring; Internet; Web-based applications; Quality of Life; Smartphones; Cancer

Outcome Measures

Primary Outcomes (1)

• Quality of Life Scores

  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.

  30, 60 and 90 days after randomization.

Secondary Outcomes (2)

• Development of Symptoms of Depression

  30, 60 and 90 days after randomization.

• Adherence to medical appointments

  90 days after randomization.

Study Arms (2)

Telemonitoring Platform

EXPERIMENTAL

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.

Device: Contigo Application

Traditional Follow-Up

NO INTERVENTION

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

Interventions

Contigo Application DEVICE

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.

Telemonitoring Platform

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Nacional Andres Bello: lead
• Centro para la Prevención y Control del Cáncer (CECAN), Santiago, Chile: collaborator

Study Sites (1)

UC Christus Cancer Centre

Santiago, Chile

RECRUITING

Related Publications (4)

• Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.

  PMID: 33538338 BACKGROUND

• Zarate V, Kind P, Valenzuela P, Vignau A, Olivares-Tirado P, Munoz A. Social valuation of EQ-5D health states: the Chilean case. Value Health. 2011 Dec;14(8):1135-41. doi: 10.1016/j.jval.2011.09.002. Epub 2011 Nov 6.

  PMID: 22152184 BACKGROUND

• Sprave T, Gkika E, Verma V, Grosu AL, Stoian R. Patient reported outcomes based on EQ-5D-5L questionnaires in head and neck cancer patients: a real-world study. BMC Cancer. 2022 Nov 29;22(1):1236. doi: 10.1186/s12885-022-10346-4.

  PMID: 36447175 BACKGROUND

• Martinez F, Taramasco C, Espinoza M, Acevedo J, Goic C, Nervi B. Effects on Quality of Life of a Telemonitoring Platform amongst Patients with Cancer (EQUALITE): A Randomized Trial Protocol. Methods Protoc. 2024 Mar 15;7(2):24. doi: 10.3390/mps7020024.

  PMID: 38525782 DERIVED

Related Links

• Center for Cancer Control and Prevention Website
• UC Christus Cancer Center

MeSH Terms

Conditions

Neoplasms; Signs and Symptoms

Condition Hierarchy (Ancestors)

Pathological Conditions, Signs and Symptoms

Study Officials

• Bruno Nervi, MD

  Pontificia Universidad Catolica de Chile

  STUDY CHAIR

• Manuel Gonzalez, PhD

  Pontificia Universidad Catolica de Chile

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Felipe T Martinez, MD, MSc

CONTACT

999690952; felipe.martinez.l@unab.cl

Carla Taramasco, PhD

CONTACT

carla.taramasco@unab.cl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

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

Study Record Dates

• First Submitted: October 10, 2023
• First Posted: October 17, 2023
• Study Start: April 1, 2024
• Primary Completion: December 1, 2024
• Study Completion: March 1, 2025
• Last Updated: April 8, 2024

Record last verified: 2024-04

Locations

CL (1)