NCT06077123|Unknown
Telemonitoring Platforms and Chemotherapy-Associated Toxicity
DETECT
Differential Effects of a Telemonitoring Platform in the Development of Chemotherapy-Associated Toxicity: A Randomised Trial
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DETECT
Differential Effects of a Telemonitoring Platform in the Development of Chemotherapy-Associated Toxicity: A Randomised Trial
Sponsor study identifier
interventional
80
1 country
2
Study Start
April 1, 2024
Actual (reported)Primary Completion
December 30, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
March 30, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 30, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 4, 2023
Actual (reported)October 11, 2023
Actual (reported)April 1, 2024
Actual (reported)December 30, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
March 30, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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
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
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.
Those assigned to the traditional follow-up group will receive standard care and in-person check-ups as determined by their attending physician.
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Centro del Cáncer, Pontificia Universidad Católica de Chile
Santiago, Chile
Complejo Asistencial Dr. Sotero del Río
Santiago, Chile
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.
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.
Bruno Nervi, MD
Pontificia Universidad Catolica de Chile
Manuel Espinoza, PhD
Pontificia Universidad Catolica de Chile
Carla Taramasco, PhD
Escuela de Ingeniería, Universidad Andrés Bello
First Submitted
October 4, 2023
First Posted
October 11, 2023
Study Start
April 1, 2024
Actual (reported)Effect of Stress Ball on Perceived Stress, Pain and Satisfaction in Cancer Patients
Integrated Cancer Services in Thailand: A Prototype for Excellence
Contact the study team to confirm eligibility.
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.
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.
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.
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.
Primary Completion
December 30, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
March 30, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
April 8, 2024
Record last verified: 2024-04
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