Effects of Telemonitoring in Quality of Life Amongst Cancer Patients

Cancer Clinical Trial

— EQUALITE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06086990
• Other study ID #: UNAB-005
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2024
• Est. completion date: March 2025

Study information

• Verified date: April 2024
• Source: Universidad Nacional Andres Bello
• Contact: Felipe T Martinez, MD, MSc
• Phone: 999690952
• Email: felipe.martinez.l[@]unab.cl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: March 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cancer
• Quality of Life
• Symptoms and Signs
• Telemedicine

Intervention

Device:
• Contigo Application
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.

Locations

Country	Name	City	State
Chile	UC Christus Cancer Centre	Santiago

Sponsors (2)

Lead Sponsor	Collaborator
Universidad Nacional Andres Bello	Centro para la Prevención y Control del Cáncer (CECAN), Santiago, Chile

Country where clinical trial is conducted

Chile, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.

External Links

•   Center for Cancer Control and Prevention Website
•   UC Christus Cancer Center