Telemedicine in Palliative Care: Interventions, Experiences and Perceptions of Patients Diagnosed With Cancer
NCT Number: NCT06538350
Acronym: PALTEL
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Advanced Cancer
Interventions: OTHER: Telemedicine Consultation|OTHER: Face-to-Face Consultation
Sponsor: OncoHelp Association
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 160
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: OTHER
Start Date: 2024-10
Completion Date: 2026-03

Summary:
The aim of this study is to estimate the effects of a palliative care consultation intervention among adults with advanced cancer delivered either as a remote (telemedicine) or face-to-face consultation, on changing symptom scores, quality of life, communication, participants' experiences, e-health literacy, emergency and unscheduled visits, adherence to treatment, retention rate, adherence rate, the level of satisfaction of patients and healthcare professionals.

Primary Outcome Measures: Patients' Quality of Life ., To determine whether telemedicine palliative care consultations are equivalent to face-to-face palliative care consultations for improving patients' quality of life as measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire(EORTC-QLQ-C30). All of the scales range in score from 0 to 100. A high score for a functional scale represents a high/healthy level of functioning whereas a high score for a symptom scale or item represents a high level of symptomatology or problems.

Patients' Quality of Life \[ Time Frame:12 weeks\] To determine whether telemedicine consultations palliative care is are equivalent to face-to-face palliative care consultations for improving patients' quality of life as measured by the EORTC-QLQ-C30 Questionnaire., 12 weeks|Changes in symptom control ., Symptom management will be measured through the mean changes in distress score on the Integrated Palliative care Outcome Scale (IPOS). There are 10 questions scored on a scale of 1-4, which assess a patient's symptoms and needs with regards to physical, social, psychological and spiritual. Individual IPOS item scores of zero or one require less clinical attention than items that score three or four., 12 weeks|Patients' satisfaction ., To assess the effect of the superiority of telemedicine versus face-to-face consultations about palliative care on patient satisfaction as measured by the 16-item measure of Patient Satisfaction Questionnaire(FAMCARE P 16 Questionnaire). This is a self-report scale assessing patient satisfaction with outpatient palliative oncology care, which is composed of 16 items rated from 1 (very dissatisfied) to 5 (very satisfied). Higher scores are related to higher satisfaction with the care received., 12 weeks
Secondary Outcome Measures: eHealth Literacy ., Participants' ability to find and evaluate online health information will be measured using the eHealth Literacy Scale. The eHealth literacy scale is an eight-item scale used to asses self-reported capability of eHealth consumers to find, appraise, and use health related information from the internet to solve health problems . Scores are interpreted as follows: Predominantly Disagree: Scores range from 8 to 15.99; Mostly Disagree: Scores range from 16 to 23.99. Mostly Agree: Scores range from 24 to 31.99. Predominantly Agree: Scores range from 32 to 40., Baseline and 12 weeks after baseline|Domain of intervention ., The interventions provided in this study will respect the principle of holistic care. Depending on the patient's needs, interventions will be provided in the physical, emotional, social, and spiritual domains during each scheduled or unscheduled visit.

During each visit, the interventions granted and the domains - physical, emotional, social and spiritual - to which these interventions belong will be recorded., 12 weeks|Number of patients satisfied with physician communication ., 14-item Communication Assessment Tool (CAT) will be used. The CAT specifically addresses patient satisfaction with key aspects of communication and interpersonal skills, and items are scored on a 1-5 scale where 1 = poor and 5 = excellent, and a higher score would indicate better communication skills., 12 weeks|Patients' experiences ., Participants' experiences with the care will be measured using the Patient Reported Experience Measures Questionnaire (PREMs). Patients' experience is rated from poor (rated as 1) to excellent (rated as 5). Higher scores are related to higher satisfaction during consultation., 12 weeks|Number of emergency room visit ., Monitoring patient interactions with the Emergency Room (ER) during the trial period., 12 weeks|Number of unscheduled visits ., Monitoring the number of unscheduled visits., 12 weeks|Adherence to intervention ., Intervention adherence will be estimated as the mean proportion of the scheduled consultations each participant completes ., 12 weeks|Changes in medication adherence ., Medication adherence will be measured using the Morisky Medication - Taking Adherence Scale (MMAS-4 Scale). The MMAS consists of four items, with a scoring scheme of "Yes" = 0 and "No" = 1. The items are summed to give a range of scores from 0 to 4 ., 12 weeks|Number of completed telemedicine scheduled visits ., Telemedicine will be feasible in this population if at least 80% complete the telemedicine visits. A visit will be considered successful if all measurements are recorded., 12 weeks|Physicians ability to evaluate a patient through telemedicine ., Measured by the Provider Satisfaction with Telemedicine Questionnaire. This questionnaire will be completed by the interventionists after visit 3 . This survey included included 5 components: demographics, care settings, experience, motivation, and overall satisfaction., 12 weeks
Other Outcome Measures: Proportion of participants enrolled, The proportion of eligible and approached patients who consent to participate., Baseline|Number of participants ineligible or refusing to participate ., Number of participants who are determined to be ineligible before the first visit., Baseline|Frequency of participant ineligibility reason, Potential study candidates who are ineligible will be recorded for reasons of ineligibility., Baseline|Frequency of participant refusal reason, Potential study candidates who decide not to participate will be recorded for refusal reasons., Baseline|Retention rate, The percentage of patients who remained in the study and did not drop out of their own accord., 12 weeks|Completion rate, The percentage of patients who completed the study period., 12 weeks