Improved Health-related Quality of Life During Peptide Receptor Radionuclide Therapy in Patients With Neuroendocrine Tumours
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 756
- 主要终点
- Change from baseline in health related quality of life at cycle 4
研究概览
简要总结
Neuroendocrine tumours (NETs) can arise in different locations in the body, and may give rise to hormonal symptoms, which may affect the patients' health-related quality of life (HRQoL). Up to four cycles of peptide receptor radionuclide therapy (PRRT) have been shown effective for symptom alleviation and prolonging survival. The aim of this study is to assess the patient's perspective, regarding changes in their HRQoL during, and at long-term follow-up after, PRRT. Patients with NET will rate their HRQoL before PRRT cycles one and four, and 1-8 years after PRRT. The patients' HRQoL will be compared to a matched reference population. The investigators hope that this study will reveal specific care needs for patients wiht NET and may provide information that will make it possible to deliver a more person-centered care.
详细描述
The inclusion criteria for PRRT were tumour somatostatin receptor expression higher than that in the normal liver found on somatostatin receptor scintigraphy (Krenning score 3 and 4), or on 68Ga-DOTATOC positron emission tomography (PET), and sufficient bone marrow, liver and kidney function. DOTATATE was labelled in house with 177Lu (IDB Holland BV, Noord Brabant, Netherlands). Up to nine cycles were given, yet a majority of patients received four cycles of PRRT.
The patients' medical records were reviewed regarding functional status (functioning versus non-functioning tumours), gender, age at diagnosis and at 1st PRRT, marital and employment status, PRRT cycles received, previous treatments and body mass index (BMI).
HRQoL was assessed using the questionnaires for cancer in general, EORTC QLQ-C30, and the gastrointestinal NET-specifically EORTC QLQ-GINET21 at every cycle.
From a large random sample (n=4,910) of the Swedish adult population, a reference population was extracted. They all had chronical diseases (diabetes, cardiac, respiratory, renal or other specified conditions) and were age and gender matched. The reference population completed only the QLQ-C30 questionnaire.
In order to investigate how HRQoL developed during the eight years after PRRT, the questionnaires were sent to 58 patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Receiving PRRT
- •NET diagnosis
排除标准
- •Not able to speak and read in Swedish or English.
结局指标
主要结局
Change from baseline in health related quality of life at cycle 4
时间窗: Baseline and before cycle 4 (each cycle is between 28-42 days)
EORTC QLQ-C30 and QLQ-GINET21 is validated, self-reported instrument assessing health related quality of life during the past week. The instruments are composed of both multi-item scales and singe-items measures. These include five functional scales, three symptom scales, a global health status scale, and six single items.
次要结局
未报告次要终点