Technology-Enhanced Palliative Care for Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 119
- 试验地点
- 2
- 主要终点
- Change in global distress score (GDS)
研究概览
简要总结
This trial investigates technology-enhanced palliative care for patients in phase I trials with cancer that has spread to other places in the body (advanced). The goal of this study is to learn if the technology-enhanced palliative care symptom-monitoring program, when combined with in-person clinic visits and standard remote care visits (by phone or video call), helps increase quality of life and care for patients with advanced cancer participating in phase 1 immunotherapy trials.
详细描述
PRIMARY OBJECTIVE:
I. To assess the effect size of each palliative care intervention technology-enhanced palliative care, standard palliative care [SPC]) on the symptom burden of patients prior to or while on a phase I trial.
SECONDARY OBJECTIVES:
I To estimate the effect size of each palliative care intervention (TEC, SPC) on symptom burden over a 12-week period of a phase I trial.
II. To estimate the effect size of each palliative care intervention (TEC, SPC) on clinical outcomes at 6 months post-enrollment.
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: Diagnosis of advanced solid tumor
- •PATIENT: Oncologic plan for a phase I trial
- •PATIENT: High symptom burden (defined as a score of >= 4 on at least 1 Edmonton Symptom Assessment Scale [ESAS] symptom, AND a global distress score [GDS] of >= 20)
- •PATIENT: Reliable telephone and internet access
- •PATIENT: Able to communicate verbally in English and provide informed consent
- •CAREGIVER: Able to communicate verbally in English and provide informed consent
- •CAREGIVER: Reliable telephone and internet access
排除标准
- •PATIENT: Low symptom burden defined as scores < 4 on all ESAS symptoms OR GDS < 20
- •PATIENT: Delirium (i.e. Memorial Delirium Assessment Scale > 8)
- •PATIENT: No reliable telephone or internet access
- •CAREGIVER: Refusal to participate in this study
- •CAREGIVER: No reliable telephone or internet access
结局指标
主要结局
Change in global distress score (GDS)
时间窗: Baseline to 2 weeks
Will consist of paired t-tests for the global distress score (GDS, calculated as a sum of 9 physical and psychosocial ESAS items, scored from 0-90 in which a range over 35 indicates high distress) between baseline and 2 weeks if the Edmonton Symptom Assessment Scale (ESAS) scores are approximately normally distributed. If the data are clearly not normally distributed will conduct Wilcoxon signed rank tests.
次要结局
- Effect size of each palliative care (PC) intervention, utilizing FAMCARE-P-13 (PRO tool assessing patient satisfaction with outpatient palliative oncology care).(At 6 months after enrollment)
- Patients' and caregivers' perceptions of receiving each technology-enhanced palliative care intervention(Up to 12 weeks on phase I trial)
- Effect size of palliative care (PC) intervention, utilizing Global Distress Score (GDS) derived from Edmonton Symptom Assessment Scale (ESAS).(At 6 months after enrollment)