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Набор скоро начнётся NCT07274904

Virtual Versus In-Person Approaches

Без фазы С лечением Cancer Palliative Care, Patient Care

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Virtual Early Palliative Care, Standard In-Person Early Palliative Care.
Кому может быть актуально
Состояния в реестре: Cancer, Palliative Care, Patient Care. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Evaluating Palliative Care Delivery: A Randomized Controlled Trial of Virtual Versus In-Person Approaches

Обзор

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.

Подробное описание

Evaluating Palliative Care Delivery: A Randomized Controlled Trial of Virtual Versus In-Person Approaches Background Palliative care is a patient- and family-centered approach that seeks to improve quality of life and alleviate suffering among individuals with serious or life-threatening illness (Wantonoro et al., 2022). It emphasizes relief from pain and other distressing symptoms while addressing psychosocial, emotional, and spiritual concerns (World Health, 2018). Unlike traditional perceptions of palliative care as end-of-life treatment, contemporary definitions underscore its integration early in the disease trajectory, delivered concurrently with curative or life-prolonging therapies (Wantonoro et al., 2022). This shift toward early integration recognizes that patients often experience significant symptom burden and psychosocial distress from the point of diagnosis of advanced illness, and that timely intervention can mitigate these challenges while fostering better coping and decision-making.

Historically, palliative care has been delivered predominantly in person through hospital-based services, outpatient clinics, or home-based programs (Ferrell et al., 2017). These models often involve interdisciplinary teams of physicians, nurses, social workers, and spiritual care providers who collaborate to provide holistic care (Ferrell et al., 2017). While effective, such models are resource intensive and may be geographically limited, especially in regions with sparse specialist availability. Technological advances and the COVID-19 pandemic accelerated the adoption of virtual modalities, demonstrating their potential to maintain continuity of care while reducing exposure risks and travel burdens (Calton et al., 2020).

Telepalliative care, including video consultations, telephone follow-ups, and digital platforms, has emerged as a feasible and effective alternative to in-person encounters. For instance, video consultations delivered by nurses in home-based settings have been shown to be feasible and cost-effective with strong patient and family engagement (Ma et al., 2025). Culturally tailored video consultations have been successfully implemented in rural hospitals lacking palliative services (Bakitas et al., 2025). Early palliative care via video visits has demonstrated equivalent outcomes to in-person care. Moreover, patients and families report that telepalliative care improves access, convenience, and satisfaction, particularly when integrated with standard care workflows (Greer et al., 2024; Mathews et al., 2023). Telehealth models are particularly appealing in contexts where specialist shortages and geographic inequities limit access.

With the growing adoption of telemedicine, attention has turned to whether virtual palliative care can achieve outcomes comparable to traditional in-person delivery (Greer et al., 2024; Sebastian et al., 2024; Yang et al., 2024). A recent systematic review and meta-analysis of randomized controlled trials in patients with chronic heart failure evaluated integrated palliative care delivered through telehealth (Sebastian et al., 2024). They found significant improvements in quality of life-measured by the Kansas City Cardiomyopathy Questionnaire and the Functional Assessment of Chronic Illness Therapy-Palliative Care scale-as well as reduced hospitalizations when compared to usual care (Sebastian et al., 2024). Similarly, a systematic review and meta-analysis focusing on informal caregivers of palliative care patients was condcuted (Yang et al., 2024). Their analysis showed that telemedicine interventions influenced caregiver outcomes, including burden, anxiety, depression, and quality of life, underscoring the broader impact of virtual models on families (Yang et al., 2024).

In addition to meta-analyses, recent large randomized controlled trials have provided high-quality evidence. A multisite randomized clinical trial involving 1,250 patients with advanced non-small cell lung cancer was condcuted (Greer et al., 2024). Participants were randomized to receive early palliative care either through secure video visits or through in-person sessions across 22 United States cancer centers. At 24 weeks, quality of life outcomes-assessed with the Functional Assessment of Cancer Therapy-Lung scale-were statistically equivalent between groups. There were also no significant differences in mood, coping, satisfaction, or health care utilization. However, caregiver participation was modestly lower in the telehealth arm, highlighting the need for tailored strategies to optimize family engagement in virtual settings (Greer et al., 2024).

Collectively, these findings provide compelling evidence that telepalliative care can deliver outcomes comparable to traditional models, while also identifying important considerations for caregiver involvement. Despite these advances, the majority of palliative care research has been conducted in high-income countries (HICs). Globally, an estimated 40 million people require palliative care annually, yet only 14% receive it, with the vast majority of unmet need concentrated in low- and middle-income countries (LMICs) (World Health Organization, 2020). Barriers in LMICs include limited specialist workforce, geographic inaccessibility, weak health system infrastructure, and competing healthcare priorities (Clark et al., 2018). Even where palliative care services exist, access is frequently inequitable, favoring urban centers and wealthier populations.

Palliative care is widely recognized as an essential component of comprehensive cancer care, yet global inequities in access remain stark. Telepalliative care has emerged as a promising strategy to extend specialist services, reduce travel burdens, and facilitate scalable models of early intervention, particularly where workforce shortages and geographic barriers limit access. Despite these advantages, robust comparative data evaluating the effectiveness of telepalliative care versus in-person delivery are lacking in LMICs. Evidence HICs may not be directly generalizable due to fundamental differences in infrastructure, digital literacy, cultural norms, and health system capacity. Recent systematic reviews reinforce this evidence gap. A comprehensive review of telehealth interventions in oncology concluded that while telepalliative care can improve psychological outcomes and enhance access, reporting on physical symptom burden and other core aspects of patient well-being remains inconsistent (Mathews et al., 2023). This highlights the need for research that rigorously evaluates the impact of telepalliative models on the physical dimensions of suffering, including pain, fatigue, and other distressing symptoms. Importantly, the Oncology Nursing Society's (ONS) current research agenda explicitly identifies precision symptom science and integration of palliative care into routine oncology practice as critical research priorities, underscoring the urgency of addressing gaps in symptom-focused evidence (Rosenzweig et al., 2024).

Taken together, these gaps establish a compelling rationale for the proposed study. By generating locally relevant, high-quality evidence on telepalliative care in LMICs, the research will address both the scientific need for data on physical symptom burden and the strategic research priorities articulated by international professional bodies. The findings will provide critical guidance for policymakers, health systems, and clinicians on how best to integrate telepalliative care into diverse contexts, ensuring that limited resources are leveraged effectively to improve patient and caregiver outcomes. Therefor, the purpose of this study is to evaluate the effectiveness, feasibility, and acceptability of tele palliative care among cancer patients in Jordan. Specifically, the study aims to determine whether tele palliative care can provide outcomes comparable to in-person care in terms of quality of life, symptom burden, and healthcare facility utilization.

Objectives and Hypotheses Primary Objectives

1. To evaluate whether telepalliative care provides quality of life outcomes comparable to in-person palliative care among cancer patients in Jordan. 2. To assess whether telepalliative care results in a comparable level of symptom burden relative to in-person palliative care. 3. To determine whether patient satisfaction with care in the telepalliative model is comparable to satisfaction reported in in-person care.

Null Hypothesis: Among cancer patients in Jordan, there are no significant differences between telepalliative care and in-person care with respect to quality of life, symptom burden, and satisfaction with care.

Secondary Objectives

1. To evaluate the effect of telepalliative care on psychological distress compared to in-person care. 2. To compare the rates of unplanned hospital visits between patients receiving telepalliative versus in-person palliative care. 3. To compare hospital admissions and length of stay between the two models of care.

Null Hypothesis: Telepalliative care does not differ significantly from in-person palliative care in terms of psychological distress, frequency of unplanned hospital visits, number of admissions, and length of hospital stay.

Methods Design This study will be conducted as a single-site, non-blinded randomized clinical trial, in which eligible participants will be randomly assigned to receive either telepalliative care or standard in-person palliative care. The non-blinded design is appropriate given the nature of the intervention, as masking participants and providers to the mode of care delivery is not feasible.

Setting The study will be conducted at the King Hussein Cancer Center (KHCC) in Amman, Jordan. KHCC is a major referral center for cancer care in the country and provides a range of oncology and supportive care services. Its palliative care program includes inpatient and outpatient services, consultation support, and a home care component delivered by an interdisciplinary team of physicians, nurses, social workers, psychologists, and spiritual care providers. The center also offers a fellowship in hospice and palliative medicine accredited by the Jordanian and Arab Medical Councils. This setting provides access to a diverse patient population and an established palliative care infrastructure in which to evaluate telepalliative care interventions.

Sample The sample will include patients referred to palliative care services within the KHCC. Participants will be eligible for inclusion if they are adults aged 18 years or older, diagnosed with solid tumours at any stage, referred to palliative care services at the KHCC, able to read and write in Arabic, and capable of providing informed consent. Patients will be excluded if they have severe cognitive impairment or psychiatric conditions that limit their ability to consent or participate meaningfully, are critically ill or receive end-of-life care where participation would cause an undue burden or are unable to participate in telehealth interventions due to lack of access to the necessary technology and absence of caregiver support.

Sampling size The sample size calculation was based on the planned statistical analysis. An independent t-test will be used to compare outcomes between the control and intervention arms of the study. Using G\*Power version 3.1, and assuming a two-tailed test with a significance level of α = 0.05, a medium effect size (Cohen's d = 0.5), power = 0.95, and a 1:1 allocation ratio, the required sample size was estimated at 105 participants per group. To account for an anticipated attrition rate of 20%, the final target sample size will be 252 participants, with 126 allocated to each group.

Study Arms The intervention Arm (Telepalliative Care) Participants randomised to the telepalliative care arm will receive scheduled palliative care consultations every four weeks, delivered primarily through virtual modalities. Vis

Вмешательства

  • Другое Virtual Early Palliative Care
    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 pers
  • Другое Standard In-Person Early Palliative Care
    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.

Первичные конечные точки

  • Quality of life (EORTC QLQ-C15-PAL) [Срок оценки: Baseline, 3 months, 6 months, and 12 months after randomization.]
  • Symptom Burden (MD Anderson Symptom Inventory - MDASI) [Срок оценки: Baseline, 3 months, 6 months, and 12 months after randomization.]
Вторичные конечные точки (1)
  • Patient Satisfaction (EORTC IN-PATSAT32) [Срок оценки: Baseline, 3 months, 6 months, and 12 months after randomization.]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Организация здравоохранения

Центры проведения

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Идентификаторы

NCT: NCT07274904 · 12-2024/25

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗