Virtual Versus In-Person Approaches
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAl Al Bayt University, Jordan
About this trial
This randomized controlled trial evaluates the effectiveness of two models of early palliative care delivery for adults with cancer: virtual care provided through scheduled video consultations and standard in-person clinic visits. Early palliative care aims to improve quality of life, manage symptoms, and support patients and families throughout the course of serious illness. Although in-person services are well established, access barriers may limit their use, and virtual care may offer a feasible alternative.
Participants are randomly assigned to receive either virtual early palliative care or in-person early palliative care. Both models include structured assessments of physical and psychological symptoms, communication and decision-making support, and routine follow-up with a palliative care specialist. Outcomes are assessed at baseline and at 3, 6, and 12 months. Primary and secondary outcomes include quality of life, symptom burden, psychological distress, patient satisfaction, and healthcare utilization.
The purpose of the study is to determine whether virtual early palliative care delivers outcomes comparable to those of traditional in-person care. The results may inform future models of palliative care delivery by identifying approaches that improve accessibility while maintaining high-quality patient support.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults aged 18 years or older
Diagnosed with a solid tumor at any stage
Referred to palliative care services at the King Hussein Cancer Center (KHCC)
Able to read and write in Arabic
Disqualifiers
Severe cognitive impairment that limits ability to consent or meaningfully participate
Psychiatric conditions that interfere with ability to consent or participate
Critically ill or receiving end-of-life care where participation would cause undue burden
Inability to participate in telehealth interventions due to lack of access to necessary technology
Trial design
Design model
Parallel
Treatments tested in this trial
Virtual Early Palliative Care
Other interventionThis intervention consists of structured early palliative care delivered primarily through secure video-based consultations approximately every four weeks. Sessions are conducted by a multidisciplinary palliative care team and include symptom assessment, management recommendations, psychosocial support, and care planning. Telephone calls may be used when video is not feasible. The clinical content mirrors standard palliative care, but all routine visits are conducted remotely rather than in person.
Standard In-Person Early Palliative Care
Other interventionThis intervention involves face-to-face early palliative care visits conducted on-site at the King Hussein Cancer Center every four weeks. Care is provided by a multidisciplinary team and includes routine symptom evaluation, treatment adjustments, psychosocial support, and additional assessments as needed. The clinical services follow standard palliative care guidelines. This arm differs from the intervention arm only in delivery mode, as all visits occur in person.
Treatment groups
252 Participants
are divided into 2 treatment groupsGroup A: Telepalliative CareExperimental treatment 1 intervention
Group B: In-Person Palliative CareActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Quality of life (EORTC QLQ-C15-PAL)
Quality of life will be measured using the EORTC QLQ-C15-PAL, a 15-item questionnaire developed for palliative cancer care. It includes functional and symptom scales and a global quality-of-life item. Scores are transformed to a 0-100 scale, with higher scores indicating better functioning or greater symptom burden depending on the domain. Mean scores will be compared between telepalliative and in-person arms over time.
Time frame
Baseline, 3 months, 6 months, and 12 months after randomization.2
Symptom Burden (MD Anderson Symptom Inventory - MDASI)
Symptom burden will be assessed using the MD Anderson Symptom Inventory (MDASI), a validated 19-item instrument that evaluates the severity of common cancer-related symptoms and the extent to which these symptoms interfere with daily functioning. Thirteen items measure symptom severity (e.g., pain, fatigue, disturbed sleep), and six items measure interference with activities, mood, and quality of life. Each item is scored on a 0-10 numeric scale, with higher scores indicating greater severity or interference. Mean symptom burden scores will be compared between telepalliative and in-person care groups over time.
Time frame
Baseline, 3 months, 6 months, and 12 months after randomization.Secondary outcomes
1
Patient Satisfaction (EORTC IN-PATSAT32)
Patient satisfaction with palliative care services will be assessed using the EORTC IN-PATSAT32, a validated 32-item questionnaire measuring patients' perceptions of quality of care and quality of service provided by healthcare professionals. The instrument covers domains such as communication, interpersonal skills, information provision, technical skills, and organizational aspects of care. Scores are transformed to a 0-100 scale, with higher scores indicating greater satisfaction. Satisfaction levels will be compared between the telepalliative care and in-person care groups.
Time frame
Baseline, 3 months, 6 months, and 12 months after randomization.Locations
Sponsors and contacts
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Al Al Bayt University, Jordan
Lead sponsor
King Hussein Cancer Center
Collaborator
Source ClinicalTrials.gov
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