Effects on Quality of Life of a Telemonitoring Platform amongst Patients with Cancer (EQUALITE): A Randomized Trial Protocol.
Felipe MartínezCarla TaramascoManuel Antonio EspinozaJohanna AcevedoCarolina GoicBruno NerviPublished in: Methods and protocols (2024)
Cancer, a pervasive global health challenge, necessitates chemotherapy or radiotherapy treatments for many prevalent forms. However, traditional follow-up approaches encounter limitations, exacerbated by the recent COVID-19 pandemic. Consequently, telemonitoring has emerged as a promising solution, although its clinical implementation lacks comprehensive evidence. This report depicts the methodology of a randomized trial which aims to investigate whether leveraging a smartphone app called Contigo for disease monitoring enhances self-reported quality of life among patients with various solid cancers compared to standard care. Secondary objectives encompass evaluating the app's impact on depressive symptoms and assessing adherence to in-person appointments. 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' progress and providing educational content to assist patients in managing common clinical situations related to their disease. The study will assess outcomes such as quality of life changes and depressive symptom development using validated scales, and adherence to in-person appointments. Specific scales include the EuroQol Group's EQ-5D questionnaire and the Patient Health Questionnaire (PHQ-9). We hypothesize that the use of Contigo will assist and empower patients receiving cancer treatment, which will translate to better quality of life scores and a reduced incidence of depressive symptoms. All analyses will be undertaken with the intention-to-treat principle by a statistician unaware of treatment allocation. This trial is registered in ClinicalTrials under the registration number NCT06086990.
Keyphrases
- depressive symptoms
- healthcare
- global health
- public health
- end stage renal disease
- quality improvement
- patient reported
- clinical trial
- newly diagnosed
- mental health
- primary care
- randomized controlled trial
- early stage
- risk factors
- social support
- palliative care
- prognostic factors
- ejection fraction
- locally advanced
- radiation therapy
- metabolic syndrome
- chronic kidney disease
- cross sectional
- risk assessment
- glycemic control
- skeletal muscle
- health information
- sleep quality
- phase iii
- case report
- amino acid
- drug induced
- open label
- double blind
- lymph node metastasis
- phase ii