Effects of Telemonitoring in Quality of Life Amongst Cancer Patients

Study Overview
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Brief Summary
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This interventional study aims to explore the potential of a smartphone app, Contigo, in enhancing the quality of life for patients with various cancers compared to standard care. The investigators will asses effects on quality of life, depressive symptoms, and appointment adherence.

Detailed Description
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The primary objective of this study is to determine if utilizing a smartphone app for disease monitoring improves the self-reported quality of life using validated questionnaires in patients with diverse solid cancers compared to standard care. Secondary objectives focused on evaluating its impact on depressive symptoms and assessing adherence to in-person appointments. This study involves a randomized trial among patients recently diagnosed with specific forms of cancer and undergoing curative treatment at the UC Christus Cancer Center. The eligible participants, 80 adults with recent histologically confirmed cancer diagnoses, will be randomized to receive either the smartphone application (Contigo) or standard educational care. Randomization will be performed independently using an allocation sequence that will be kept concealed from clinical investigators. Contigo offers two primary functions: monitoring cancer patients and delivering educational content to aid patients in dealing with common clinical situations related to their disease. The study will assess outcomes such as quality of life changes, depressive symptom development, and adherence to in-person appointments. All analyses will be undertaken under the intention to treat principle by a statistician unaware of treatment allocation.

Official Title
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Effects in Quality of Life of a Telemonitoring Platform Amongst Patients With Cancer: A Randomized Trial

Conditions
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Cancer, Telemonitoring, Telemedicine, Symptoms and Signs, Quality of Life

Intervention / Treatment
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* Device: Contigo Application


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients (>18 years old). Recent histologically confirmed diagnosis (within the last 3 months) of bronchogenic, breast, gallbladder, gastric, colorectal, or prostate cancer in any of its forms. Awaiting initiation of curative intent treatment for the disease using any modality (radiation therapy, chemotherapy, immunotherapy, etc.) at the UC-Christus Cancer Center. Possession of a smartphone, regardless of its native operating system (iOS® or Android®). Willingness to sign an informed consent form to participate in the study. Exclusion Criteria: Any form of sensory impairment preventing app usage. Cognitive impairment. Psychiatric pathology hindering app usage. Unwillingness to participate in the study. Concurrent participation in another clinical trial addressing healthcare technologies.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants will be randomly allocated in a 1:1 fashion to receive the smartphone application or usual follow-up care.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Telemonitoring Platform<br>Patients assigned to the active intervention group will have access to a smartphone application named Contigo. This application is designed to identify signs and symptoms of oncology drug toxicity while providing educational content. It equips patients with the necessary tools to manage typical clinical situations associated with the diagnosis and treatment of their disease. | Device: Contigo Application<br>* Contigo, a smartphone app, focuses on two main goals: monitoring cancer patients for early signs of drug toxicity and offering educational content to empower them in managing clinical challenges linked to their diagnosis and treatment. Monitoring involves patients inputting experiences via oncology-related questionnaires, with weekly checks for chemotherapy toxicity using a validated questionnaire (PRO-CTCAE). Severe cases trigger alerts, while milder ones receive educational guidance. Data collected is shared with healthcare providers. Educational content, backed by scientific evidence and expert collaboration, covers cancer-specific topics and healthcare processes to enhance patients' self-awareness and self-care practices.<br>|
| No Intervention: Traditional Follow-Up<br>Individuals designated to the traditional follow-up group will undergo standard care, including in-person check-ups as determined by their attending physician. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life Scores | Quality of Life 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. | 30, 60 and 90 days after randomization. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Development of Symptoms of Depression | Development of symptoms of depression as evaluated by the Patient Health Questionnaire 9 (PHQ-9) scale. Scores can range from 0 to 27, with higher scores increasing the probability of depression. | 30, 60 and 90 days after randomization. | 
| Adherence to medical appointments | Adherence to in-person medical appointments, as established by the attending physician of each participant. This outcome will be expressed as the proportion of visits attended by each patient. | 90 days after randomization. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Telemonitoring, Internet, Web-based applications, Quality of Life, Smartphones, Cancer