Effects of Telemonitoring in Quality of Life Amongst Cancer Patients (EQUALITE)
April 5, 2024 updated by: Felipe Martinez Lomakin, Universidad Nacional Andres Bello
Effects in Quality of Life of a Telemonitoring Platform Amongst Patients With Cancer: A Randomized Trial
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.
Study Overview
Status
Recruiting
Intervention / Treatment
Detailed Description
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.
Study Type
Interventional
Enrollment (Estimated)
80
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Carla Taramasco, PhD
- Email: carla.taramasco@unab.cl
Study Contact Backup
- Name: Felipe T Martinez, MD, MSc
- Phone Number: +56 999690952
- Email: felipe.martinez.l@unab.cl
Study Locations
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-
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Santiago, Chile
- Recruiting
- UC Christus Cancer Centre
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Contact:
- Bruno Nervi, MD
- Phone Number: +56 23546900
- Email: bnervi@uc.cl
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Telemonitoring Platform
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.
|
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.
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No Intervention: Traditional Follow-Up
Individuals designated to the traditional follow-up group will undergo standard care, including in-person check-ups as determined by their attending physician.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Quality of Life Scores
Time Frame: 30, 60 and 90 days after randomization.
|
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.
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30, 60 and 90 days after randomization.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Development of Symptoms of Depression
Time Frame: 30, 60 and 90 days after randomization.
|
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.
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30, 60 and 90 days after randomization.
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Adherence to medical appointments
Time Frame: 90 days after randomization.
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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.
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90 days after randomization.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: Bruno Nervi, MD, Pontificia Universidad Católica de Chile
- Principal Investigator: Manuel Gonzalez, PhD, Pontificia Universidad Católica de Chile
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- Sprave T, Gkika E, Verma V, Grosu AL, Stoian R. Patient reported outcomes based on EQ-5D-5L questionnaires in head and neck cancer patients: a real-world study. BMC Cancer. 2022 Nov 29;22(1):1236. doi: 10.1186/s12885-022-10346-4.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 2024
Primary Completion (Estimated)
December 1, 2024
Study Completion (Estimated)
March 1, 2025
Study Registration Dates
First Submitted
October 10, 2023
First Submitted That Met QC Criteria
October 10, 2023
First Posted (Actual)
October 17, 2023
Study Record Updates
Last Update Posted (Actual)
April 8, 2024
Last Update Submitted That Met QC Criteria
April 5, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Other Study ID Numbers
- UNAB-005
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
IPD Plan Description
Anonymized individual participant data, encompassing clinical characteristics and outcomes, will be accessible to fellow researchers upon reasonable request.
This access can aid in conducting a systematic review on telemonitoring platforms for providing care to cancer patients.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.