Cancer, Chemotherapeutic Agent Toxicity
Conditions
Keywords
Telemonitoring, Internet, Smartphones, Quality of Life, User Satisfaction
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.
Interventions
DEVICEContigo Application
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.
Sponsors
Centro para la Prevención y Control del Cáncer (CECAN), Santiago, Chile
Universidad Nacional Andres Bello
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Experience Scores | 3 months after randomization | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life Scores | 3 months after randomization | Quality of Life scores 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. |
| Severe adverse event attributable to chemotherapy | 3 months after randomization | Proportion of patients who develop a severe adverse event attributable to cytotoxic chemotherapy. Severe events will be those of grade 3 to 5 of the Common Terminology Criteria for Adverse Events classification. |
| Hospitalizations due to a chemotherapy adverse event | 3 months after randomization | Propotion of patients who require hospitalizations due to an adverse event attributable to cytotoxic chemotherapy |
| Chemotherapy dose adjustment | 3 months after randomization | Proportion of patients who require a reduction in their chemotherapy dose in each group. |
| Emergency department visits | 3 months after randomization | Median number of emergency department visits in each study group |
Countries
Chile
Contacts
Primary ContactFelipe Martinez, MD, MSc
Backup ContactCarla Taramasco, PhD
Outcome results
None listed