Clinical trial NCT06086990: Effects of Telemonitoring in Quality of Life Amongst Cancer Patients
Official title: Effects in Quality of Life of a Telemonitoring Platform Amongst Patients With Cancer: A Randomized Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cancer
Telemonitoring
Telemedicine
Symptoms and Signs
Quality of Life
Keywords: Telemonitoring
Internet
Web-based applications
Quality of Life
Smartphones
Cancer
Lead sponsor: Universidad Nacional Andres Bello
Sponsor class: OTHER
Collaborators: name: Centro para la Prevención y Control del Cáncer (CECAN), Santiago, Chile
First posted: 2023-10-17
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomly allocated in a 1:1 fashion to receive the smartphone application or usual follow-up care.
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Quality of Life Scores
timeFrame: 30, 60 and 90 days after randomization.
Secondary outcomes:
measure: Development of Symptoms of Depression
timeFrame: 30, 60 and 90 days after randomization.
measure: Adherence to medical appointments
timeFrame: 90 days after randomization.
Other outcomes:
Locations:
city: Santiago
country: Chile
facility: UC Christus Cancer Centre
Study officials:
affiliation: Pontificia Universidad Catolica de Chile
name: Bruno Nervi, MD
role: STUDY_CHAIR
affiliation: Pontificia Universidad Catolica de Chile
name: Manuel Gonzalez, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
citation: 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.