Telemonitoring Platforms and Chemotherapy-Associated Toxicity

NCT06077123 | Recruiting

• 1 other identifier: UNAB-004
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Cancer; Chemotherapeutic Agent Toxicity

Keywords

Telemonitoring; Internet; Smartphones; Quality of Life; User Satisfaction

Outcome Measures

Primary Outcomes (1)

• Patient Experience Scores

  Patient Satisfaction with Healthcare Services Provided using the European Organisation for Research and Treatment of Cancer Satisfaction with Cancer Care for Outpatients questionnaire (EORTC OUTPATSAT-35). Scores can range from 0 to 100 points, with higher scores implying greater satisfaction with care.

  3 months after randomization

Secondary Outcomes (5)

• Quality of Life Scores

  3 months after randomization

• Severe adverse event attributable to chemotherapy

  3 months after randomization

• Hospitalizations due to a chemotherapy adverse event

  3 months after randomization

• Chemotherapy dose adjustment

  3 months after randomization

• Emergency department visits

  3 months after randomization

Study Arms (2)

Telemonitoring Platform

EXPERIMENTAL

Patients allocated to the active intervention group will receive a smartphone application called Contigo. This tool aims to detect signs and symptoms of oncology drug toxicity and delivering educational content that enables the patient to have tools to address common clinical situations associated with the diagnosis and treatment of their disease.

Device: Contigo Application

Traditional Follow-Up

NO INTERVENTION

Those assigned to the traditional follow-up group will receive standard care and in-person check-ups as determined by their attending physician.

Interventions

Contigo Application DEVICE

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.

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)
• 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®)

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (2)

Centro del Cáncer, Pontificia Universidad Católica de Chile

Santiago, Chile

RECRUITING

Complejo Asistencial Dr. Sotero del Río

Santiago, Chile

NOT YET RECRUITING

Related Publications (6)

• 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

• Arnold B, Mitchell SA, Lent L, Mendoza TR, Rogak LJ, Barragan NM, Willis G, Medina M, Lechner S, Penedo FJ, Harness JK, Basch EM; PRO-CTCAE Spanish Translation and Linguistic Validation Study Group. Linguistic validation of the Spanish version of the National Cancer Institute's Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). Support Care Cancer. 2016 Jul;24(7):2843-51. doi: 10.1007/s00520-015-3062-5. Epub 2016 Feb 2.

  PMID: 26838022 BACKGROUND

• Basch E, Stover AM, Schrag D, Chung A, Jansen J, Henson S, Carr P, Ginos B, Deal A, Spears PA, Jonsson M, Bennett AV, Mody G, Thanarajasingam G, Rogak LJ, Reeve BB, Snyder C, Kottschade LA, Charlot M, Weiss A, Bruner D, Dueck AC. Clinical Utility and User Perceptions of a Digital System for Electronic Patient-Reported Symptom Monitoring During Routine Cancer Care: Findings From the PRO-TECT Trial. JCO Clin Cancer Inform. 2020 Oct;4:947-957. doi: 10.1200/CCI.20.00081.

  PMID: 33112661 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

• Arraras JI, Illarramendi JJ, Viudez A, Lecumberri MJ, de la Cruz S, Hernandez B, Zarandona U, Bredart A, Martinez M, Salgado E, Lainez N, Vera R. The cancer outpatient satisfaction with care questionnaire for chemotherapy, OUT-PATSAT35 CT: a validation study for Spanish patients. Support Care Cancer. 2012 Dec;20(12):3269-78. doi: 10.1007/s00520-012-1467-y. Epub 2012 May 2.

  PMID: 22549507 BACKGROUND

• Martinez F, Taramasco C, Espinoza M, Acevedo J, Goic C, Nervi B. Differential Effects of a Telemonitoring Platform in the Development of Chemotherapy-Associated Toxicity: A Randomized Trial Protocol. Diagnostics (Basel). 2024 Mar 14;14(6):619. doi: 10.3390/diagnostics14060619.

  PMID: 38535039 DERIVED

Related Links

• Center for Cancer Control and Prevention Website

MeSH Terms

Conditions

Neoplasms

Study Officials

• Bruno Nervi, MD

  Pontificia Universidad Catolica de Chile

  STUDY CHAIR

• Manuel Espinoza, PhD

  Pontificia Universidad Catolica de Chile

  PRINCIPAL INVESTIGATOR

• Carla Taramasco, PhD

  Escuela de Ingeniería, Universidad Andrés Bello

  STUDY DIRECTOR

Central Study Contacts

Felipe Martinez, MD, MSc

CONTACT

+56 9 99690953; 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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Patients will be randomized in a 1:1 ratio using a permuted block method to receive one of the two intervention strategies.

Study Record Dates

• First Submitted: October 4, 2023
• First Posted: October 11, 2023
• Study Start: April 1, 2024
• Primary Completion: December 30, 2024
• Study Completion: March 30, 2025
• Last Updated: April 8, 2024

Record last verified: 2024-04

Locations

CL (2)