Rectal Administration of Opioids for Comfort Care in Advanced Cancer Patients Using the Macy Catheter
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Feasibility of using the device 'Macy catheter' for rectal administration of opioids for comfort in cancer patients on palliative care as defined by number of doses administered and patient satisfaction
研究概览
简要总结
This trial studies how well rectal administration of opioids using the Macy catheter works in reducing pain in patients with cancer that has spread to other anatomic sites or is no longer responding to treatment. Rectal administration of opioids using the Macy catheter may help to reduce the cost of care, resolve the issue of medication availability currently faced in the form of parenteral opioid shortage throughout the country, and provide adequate comfort and symptom relief for patients with smoother transition out of hospital.
详细描述
PRIMARY OBJECTIVES:
I. Determine the feasibility of using the device 'Macy catheter' for rectal administration of opioids for comfort in cancer patients on palliative care.
SECONDARY OBJECTIVES:
I. To determine the ease of use, level of satisfaction and overall perception of effectiveness of 'Macy catheter' for rectal administration of opioids for pain control in advanced cancer patients, by the hospital bedside nursing staff.
II. To assess patients' (or primary care-giver's) experience of using the 'Macy catheter' 48 hours after discharge from the hospital.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 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
- •Adult patients admitted to the inpatient Acute Palliative Care Unit (APCU) at MD Anderson Cancer Center
- •Candidate for taking short acting opioids and/or methadone, with or without transdermal fentanyl, for control of cancer related pain
- •Impaired oral/gastrointestinal (GI) route for medicine intake (due to, but not limited to, any level of gastrointestinal obstruction, severe nausea and/or vomiting, odynophagia and/or dysphagia due to severe mucositis, tumor, muscle weakness or in-coordination)
- •Advanced cancer defined as cancer with no further oncological management and patients are at end of life (EOL) or recommended for best supportive/comfort care (estimated prognosis less than 6 months)
- •Able and willing to read and sign in English
排除标准
- •Non-English speaking
- •Contraindications to use of the Macy catheter (
- •Not be used for patients with rectal lesions, tumors, active rectal bleeding and/or compromised rectal mucosa [i.e. ulceration or ischemic proctitis],
- •Patients with diarrhea, or more than 1 liquid stool per day,
- •Patients with recent bowel surgery [less than 6 weeks],
- •Thrombocytopenia [platelet count less than 20,000, checked in the last 1 week])
- •Patients who are unable to take oral medications due to severe constipation only, which can be adequately managed by bowel laxative regimen
结局指标
主要结局
Feasibility of using the device 'Macy catheter' for rectal administration of opioids for comfort in cancer patients on palliative care as defined by number of doses administered and patient satisfaction
时间窗: Up to 1 year
Will be assessed by the number of doses that a patient finishes (at least 4 out of 6 doses administered) and by asking patients' about their level of satisfaction and overall perception of effectiveness of using the device, collected by question 10 and 11 in the survey, respectively. The association between patients' demographics and clinical characteristics and patients' satisfaction and perception of effectiveness will be evaluated by Wilcoxon rank sum test and chi-square (or Fisher's exact) test for continuous and categorical variables, respectively. In order to address the primary objective, the feasibility rate will be estimated and reported along with a 95% Clopper-Pearson exact confidence interval.
次要结局
- Episodes of confusion (delirium) assessed by primary caregiver survey(Up to 1 year)
- Hospice nurse experience assessed by survey(Up to 1 year)