Efficacy of telemedicine for cancer patients in outpatient palliative care setting: Protocol of a randomized, open-label, non-inferiority study.

BACKGROUND

The growing number of patients diagnosed with advanced cancer increases the pressure on health systems, especially in lower-middle-income countries. Telemedicine palliative care consultation is innovative in providing quality cancer care while reducing costs. However, there is a lack of randomized controlled studies that evaluate the effects of digital consultations in the palliative treatment of cancer patients. This study aims to investigate the efficacy of telemedicine consultation in outpatient palliative care settings.

METHODS/

DESIGN

During an 18-month recruitment period, participants recently diagnosed with advanced cancer who are not already receiving palliative care are invited to participate in a randomized controlled trial. Eligible participants are randomized to the intervention group (telemedicine) or the control group (face-to-face) consultations. Patients have monthly scheduled consultations (three such consultations), and unscheduled consultations as needed, provided through telemedicine or face-to-face visits. The primary outcomes are patients' quality of life assessed monthly using the EORTC-QLQ-C30 Questionnaire, changes in self-reported symptom control measured at every visit through the mean changes in distress score on the IPOS Questionnaire, and patients' satisfaction assessed monthly using the FAMCARE P16 Questionnaire. Secondary outcomes are eHealth Literacy, the domain of intervention, number of patients satisfied with physician communication, patients' experiences with the care, number of emergency room visits, number of unscheduled visits, adherence to intervention, changes in medication adherence, number of completed telemedicine scheduled visits, and physician's ability to evaluate a patient through telemedicine.

DISCUSSION: This is one of the first randomized controlled trials investigating virtual palliative care. Our data will determine whether telemedicine is appropriate for outpatient palliative care.

TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT06538350.