Telemonitoring Platforms and Chemotherapy-Associated Toxicity

Trial Title: Telemonitoring Platforms and Chemotherapy-Associated Toxicity

NCT ID: NCT06077123

Condition: Cancer
Chemotherapeutic Agent Toxicity

Conditions: Keywords:
Telemonitoring
Internet
Smartphones
Quality of Life
User Satisfaction

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

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

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

Intervention:

Intervention type: Device
Intervention name: Contigo Application
Description: 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.
Arm group label: Telemonitoring Platform

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.

Criteria for 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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Centro del Cáncer, Pontificia Universidad Católica de Chile

Address:
City: Santiago
Country: Chile

Status: Recruiting

Contact:
Last name: Bruno Nervi, MD
Email: bnervi@uc.cl

Facility:
Name: Complejo Asistencial Dr. Sotero del Río

Address:
City: Santiago
Country: Chile

Status: Not yet recruiting

Contact:
Last name: Bruno Nervi, MD

Phone: 25762300
Email: bnervi@uc.cl

Start date: April 1, 2024

Completion date: March 30, 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/NCT06077123
https://cecan.cl/