Clinical trial NCT06077123: Telemonitoring Platforms and Chemotherapy-Associated Toxicity
Official title: Differential Effects of a Telemonitoring Platform in the Development of Chemotherapy-Associated Toxicity: A Randomised Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cancer
Chemotherapeutic Agent Toxicity
Keywords: Telemonitoring
Internet
Smartphones
Quality of Life
User Satisfaction
Lead sponsor: Universidad Nacional Andres Bello
Sponsor class: OTHER
Collaborators: name: Centro para la Prevención y Control del Cáncer (CECAN), Santiago, Chile
First posted: 2023-10-11
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will be randomized in a 1:1 ratio using a permuted block method to receive one of the two intervention strategies.
Primary purpose: TREATMENT

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.

Detailed description: This protocol describes a randomized parallel-group clinical trial among recently diagnosed patients with solid carcinomas preparing for curative intent chemotherapy at Hospital Sótero del Río and UC-Christus Health Network centers. Eligible adult patients (\>18 years) diagnosed with lung, gastric, gallbladder, colon, breast, or cervical carcinoma, scheduled for outpatient curative intent chemotherapy within UC-Christus Health Network or Hospital Sotero del Rio from November 2023 to July 2024, proficient in Spanish, and possessing a smartphone (iOS® or Android®) will be recruited. Exclusions include those undergoing concomitant radiotherapy, sensory impairments hindering app use, cognitive or psychiatric issues, and unwillingness to participate. Participants will be randomized 1:1 to receive either the Contigo smartphone application or standard care. Contigo aims to monitor chemotherapy toxicity symptoms and deliver cancer-related educational content. The application includes modules addressing cancer care, self-perception of health, patient experiences, frequently asked questions, community resources, and scheduling. Information collected by the app will be available to healthcare providers. Patients will receive the app for free and undergo training on its usage. Weekly toxicity assessments using Patient-Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) will be conducted. The control group will receive standard in-person care. The primary outcome is patient experience during chemotherapy, measured using the OUT-PATSAT-35 questionnaire three months after randomization. Secondary outcomes include severe chemotherapy-associated toxicity, quality of life, and user satisfaction with the application. A sample size of 80 participants (40 per group) was calculated. Descriptive analysis will utilize means, standard deviation, frequencies, and percentages. Inferential analysis will involve t-tests, Mann-Whitney U tests, Fisher's Exact Test, and Kaplan-Meier survival curves. All analyses will adhere to intention-to-treat principles and use Stata v.16.0® software. No subgroup analyses have been programmed.

Eligibility criteria: Inclusion Criteria:

* 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®)

Exclusion Criteria:

* 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

Primary outcomes:
measure: Patient Experience Scores
timeFrame: 3 months after randomization
Secondary outcomes:
measure: Quality of Life Scores
timeFrame: 3 months after randomization
measure: Severe adverse event attributable to chemotherapy
timeFrame: 3 months after randomization
measure: Hospitalizations due to a chemotherapy adverse event
timeFrame: 3 months after randomization
measure: Chemotherapy dose adjustment
timeFrame: 3 months after randomization
measure: Emergency department visits
timeFrame: 3 months after randomization
Other outcomes:
Locations:
city: Santiago
country: Chile
facility: Centro del Cáncer, Pontificia Universidad Católica de Chile
city: Santiago
country: Chile
facility: Complejo Asistencial Dr. Sotero del Río
Study officials:
affiliation: Pontificia Universidad Catolica de Chile
name: Bruno Nervi, MD
role: STUDY_CHAIR
affiliation: Pontificia Universidad Catolica de Chile
name: Manuel Espinoza, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Escuela de Ingeniería, Universidad Andrés Bello
name: Carla Taramasco, PhD
role: STUDY_DIRECTOR
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citation: 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.