The Effect of Specialized Palliative Telemedicine for Patients with Advanced Cancer At Home
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change from baseline patient's health-related quality of life at 2 weeks, 4 weeks, 8 weeks, and 6 months
研究概览
简要总结
Specialized palliative care (SPC) plays an important role in providing patient-centered care and support to informal caregiver, besides establishing/intensifying/coordinating collaboration with primary and secondary health care sectors (hospital nurse/district nurse and general practitioner/oncologist) to improve care and support for patients and burdened informal caregiver. This study proposes to develop a SPC intervention enriched with a dyadic psychological intervention for patients with advanced cancer and their informal caregiver delivered by telemedicine at home (TeleSPC). It is our hypothesis that the intervention can enhance patient-centered care at home, support their informal caregiver, and improve relations/integration between the SPC teams, oncologic teams, the general practitioners and district nurses.
详细描述
This is a pilot randomized controlled trial in an open-label fashion, which proposes to develop a SPC intervention enriched with a dyadic psychological intervention (needs-based therapeutic framework based on existential-phenomenological therapy) for patients with advanced cancer and their informal caregiver delivered by telemedicine (video consultation) at home. The primary aim is to investigate the intervention effects on the patients' health-related quality of life (HRQoL). The secondary aims will be to analyze the intervention effects on number of hospitalizations, days spent at home, hospital admissions, survival, dyadic coping between patients and informal caregiver, staff satisfaction with the intervention and caregiver burden in patients' informal caregiver.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient inclusion criteria:
- •adults (at least 18 years old)
- •solid organ cancer
- •no longer receives curativ treatment
- •provide written informed consent
- •are able to speak and understand Danish Language
- •are cognitively able to participate in the study
- •have at least one symptom or problem with score ≥ 3 at the EORTC QLQ-C30
排除标准
- •primary brain cancer or central nervous system metastases
- •a prognosis of less than six months
- •incapable of cooperating in the trial
- •already receive SPC
- •Informal caregiver inclusion criteria:
- •adults (at least 18 years old)
- •indicated by the patient as the closest informal caregiver
- •able to speak and understand danish langues
- •provide written informed consent
- •Informal caregiver exclusion criteria:
- •- refuse to participate in the study
研究组 & 干预措施
TeleSPC
Patients will be offered regular multidisciplinary video consultations with the SPC team and these patients and their informal caregiver will also be offered a dyadic psychological intervention.
Regular multidisciplinary video consultations with multidisciplinary team, involvering cooperation between the section og Palliative medicine and the Department of Oncology, District nurse and the general practitioner.
Operationel definition of informal caregiver: Patients will designated the closest person involved in their care (e.g., spouse, son/daughter, other relatives, and friends).
干预措施: TeleSPC (Other)
Control
Patients will follow the current practice in the healthcare system (standard care). Control patients will be offered information to clarify the options available in case of unmet palliative needs. Patients' informal caregiver will be invited to participate in the study, but no intervention will be offered.
结局指标
主要结局
Change from baseline patient's health-related quality of life at 2 weeks, 4 weeks, 8 weeks, and 6 months
时间窗: Baseline, 2 weeks, 4 weeks, 8 weeks, and 6 months
The European Organisation for Research and Treatment of Cancer Quality of life Questionnaire - Core 30 (EORTC QLQ-C30) to assess several physical and psychosocial aspects of the patient's health-related quality of life. Scores range from 0 to 100; high values in the functioning and quality of life scales and low values in the symptoms scales indicate better outcomes.
次要结局
- Change from baseline caregiver burden at 4 weeks, 8 weeks, and 6 months(Baseline, 4 weeks, 8 weeks, and 6 months)
- Change from baseline informal caregiver health related quality of life at 4 weeks, 8 weeks, and 6 months(Baseline, 4 weeks, 8 weeks, and 6 months)
- Healthcare professionals' satisfaction with intervention at 6 months(6 months)
- Change from baseline patients' sleep at 2 weeks, 4 weeks, 8 weeks, and 6 months(Baseline, 2 weeks, 4 weeks, 8 weeks, and 6 months)
- Change from baseline informal caregivers' anxiety at 4 weeks, 8 weeks, and 6 months(Baseline, 4 weeks, 8 weeks, and 6 months)
- Patients and informal caregivers' satisfaction with intervention at 6 months(6 months)
- Change from baseline patients' use of health care system at 6 months(Baseline and 6 months)
- Change from baseline patients and informal caregiver dyadic coping at 4 weeks, 8 weeks, and 6 months(Baseline, 4 weeks, 8 weeks, and 6 months)
- Change from baseline patients' anxiety at 2 weeks, 4 weeks, 8 weeks, and 6 months(Baseline, 2 weeks, 4 weeks, 8 weeks, and 6 months)
- Change from baseline patient's depression at 2 weeks, 4 weeks, 8 weeks, and 6 months(Baseline, 2 weeks, 4 weeks, 8 weeks, and 6 months)
- Change from baseline informal caregivers' depression at 4 weeks, 8 weeks, and 6 months(Baseline, 4 weeks, 8 weeks, and 6 months)
研究者
Geana P Kurita
Senior Researcher
Rigshospitalet, Denmark