Virtual Versus In-Person Approaches

NCT07274904 | Not Yet Recruiting

• 1 other identifier: 12-2024/25
• Study Type: interventional
• Target: 252
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Cancer; Palliative Care, Patient Care

Keywords

Palliative care; Virtual; Care

Outcome Measures

Primary Outcomes (2)

• 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.

  Baseline, 3 months, 6 months, and 12 months after randomization.

• 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.

  Baseline, 3 months, 6 months, and 12 months after randomization.

Secondary Outcomes (1)

• Patient Satisfaction (EORTC IN-PATSAT32)

  Baseline, 3 months, 6 months, and 12 months after randomization.

Study Arms (2)

Telepalliative Care

EXPERIMENTAL

Participants assigned to this arm will receive early palliative care delivered primarily through scheduled virtual visits. Consultations will occur approximately every four weeks using secure video-conferencing platforms or, when necessary, telephone calls. A multidisciplinary palliative care team-including physicians, nurses, and other supportive care providers-will conduct symptom assessments, provide management recommendations, offer psychosocial support, and engage in care planning. Caregivers may join the virtual sessions when available. Additional follow-up contacts may be arranged to address urgent concerns or symptom changes. The clinical content is equivalent to standard in-person palliative care; only the delivery modality differs.

Other: Virtual Early Palliative Care

In-Person Palliative Care

ACTIVE COMPARATOR

Participants assigned to the control arm will receive standard early palliative care through face-to-face clinic visits at the King Hussein Cancer Center every four weeks. Care is provided by a multidisciplinary team consisting of physicians, nurses, social workers, and other supportive care professionals. Services include routine symptom monitoring, adjustment of treatment plans, psychosocial support, and additional assessments as clinically indicated. All clinical content follows evidence-based palliative care guidelines. The primary difference from the intervention arm is that care is delivered in person rather than virtually.

Other: Standard In-Person Early Palliative Care

Interventions

Virtual Early Palliative Care OTHER

This 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.

Telepalliative Care

Standard In-Person Early Palliative Care OTHER

This 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.

In-Person Palliative Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Capable of providing informed consent

You may not qualify if:

• 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
• Absence of caregiver support when needed for telehealth participation

Sponsors & Collaborators

• Al Al Bayt University, Jordan: lead
• King Hussein Cancer Center: collaborator

MeSH Terms

Conditions

Neoplasms

Central Study Contacts

Mohammad I Al Qadire, PhD

CONTACT

+962797310332; mohammadqadire@aabu.edu.jo

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 28, 2025
• First Posted: December 10, 2025
• Study Start: February 1, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: December 11, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share