Study on Quality of Life in Advanced Cancer Patients With Opioid-induced Constipation Treated With Naloxegol
A Multicenter, Observational Prospective Study on Quality of Life (QOL) in Advanced Cancer Patients With Opioid-induced Constipation (OIC) Treated at Home With Naloxegol According to the Clinical Practice
Opioid-Induced Constipation (OIC) is often associated with a compromised quality of life of patients in palliative care (PC) setting. Among the Peripherally-Acting Mu-Opioid Receptor Antagonists, Naloxegol is the most effective to treat OIC and to improve OIC-related aspects of quality of life in patients with non-cancer pain.
This observational study aims to assess the impact of a 4-weeks Naloxegol therapy on the quality of life in advanced cancer patients with OIC assisted by a home PC program.
The study is enrolling cancer patients with OIC (defined according to Rome IV criteria) not relieved by first-line laxatives, starting the therapy with 25 mg/day of Naloxegol. The main parameters evaluated at the beginning of the therapy (T0) and after 28 days (T28) are: Patient Assessment of Constipation Quality-of-Life (PAC-QoL, 4 subscales: physical discomfort, psychosocial discomfort, worries and concerns, satisfaction), evaluation of objective (number of weekly evacuations) and subjective constipation (Bowel Function Index, BFI, normal score<30), pain assessment by NRS.
研究概览
研究类型
注册 (实际的)
联系人和位置
学习地点
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BO
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Bologna、BO、意大利、40128
- Fondazione ANT Italia ONLUS
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- cancer patients with advanced disease;
- age higher than 18 years;
- mentally competent;
- naloxegol therapy for no more than 1 week according to clinical practice;
- sign of a written informed consent.
Exclusion Criteria:
- patient with pain not controlled by opioids;
- therapy with other PAMORAs;
- intestinal obstruction;
- risk of intestinal perforation.
- severe renal failure.
学习计划
研究是如何设计的？
设计细节
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Patient Assessment of Constipation Quality-of-Life (PAC-QoL) score
大体时间：4 weeks
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Change of quality of life evaluated by Patient Assessment of Constipation Quality-of-Life (PAC-QoL) at T0 and T28.
Each item of the 28-item questionnaire was scored on a 5-point Likert-type scale from 0 to 4, with (0 = none/not at all, 1 = a little bit/a little bit of the time, 2 = moderately/some of the time, 3 = quite a bit/most of the time, 4 = extremely/all the time).
Scores were reported overall and for each of the four subscales (physical discomfort, psychosocial discomfort, worries and concerns, and satisfaction).
An improvement (reduction) of ≥1 point in PAC-QOL score was considered clinically significant based on previous validation studies.
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4 weeks
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Objective constipation
大体时间：4 weeks
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Change of objective constipation evaluated by number of weekly evacuations.
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4 weeks
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Subjective constipation
大体时间：4 weeks
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Change of subjective constipation evaluated by Bowel Function Index (BFI).
The BFI is a physician-administered, patient-assessment scale made up of three items: (1) ease of defecation, (2) feeling of incomplete bowel evacuation, and (3) personal judgement of constipation during the last 7 days.
The physician asks the patient to rate his or her impression of each of the three items during the previous week on a scale from 0 to 100, with 0 signifying 'not at all' and 100 signifying 'very strong'.
The score is then calculated as the average of the three components of the scale with each component being weighted equally.
The BFI total score remains on a scale of 0 to 100 with higher scores indicating greater constipation.
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4 weeks
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Pain (Numeric Rating Scale)
大体时间：4 weeks
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Change of pain assessed by Numeric Rating Scale (NRS).
The NRS is a 11-points numeric scale through participants were asked to rate their average pain intensity by selecting a single number from 0 to 10. Higher scores indicate a more severe pain.
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4 weeks
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合作者和调查者
调查人员
- 首席研究员：Enrico Ruggeri, MD、Fondazione ANT Italia ONLUS
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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