Symptom Support During Chemotherapy: A Mixed Method Study in Adult Patients With Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 143
- 试验地点
- 1
- 主要终点
- Overall symptom distress
研究概览
简要总结
This study evaluates the value of a nursing symptom support en selfmanagement intervention for adult patients with cancer treated with chemotherapy. Using a prospective sequential design with a comparison group who receives standard care and a (later) intervention group who gets the nursing intervention, we will evaluate the effect of this nursing intervention on overall symptom distress (primary outcome) and other measures of symptom burden, self-efficacy, outcome expectations and self-care. By conducting sem-structured interviews with some participants of the intervention group, we will study the patient experience of the intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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
- •Patients starting first line treatment with (intravenous) chemotherapy
- •Ambulatory patients or patients who receive their treatment during short hospital stays
- •Regardless of type of cancer, treatment or treatment intention (curative or palliative)
- •Who understand sufficiently Dutch to fill out questionnaires
- •Who sign informed consent for their participation in the study
排除标准
- •Oral anticancer treatment
- •Concomitant chemoradiotherapy
- •Breast cancer patients who receive nurse counseling throughout their therapy
- •Experimental therapy in the context of a clinical trial
结局指标
主要结局
Overall symptom distress
时间窗: Longitudinal, during first 3 months after start of treatment
Summed symptom distress as self-reported on the Symptom Burden Questionnaire
Overall symptom severity
时间窗: Longitudinal, during first 3 months after start of treatment
Summed symptom severity as self-reported on the Symptom Burden Questionnaire
次要结局
- Total self-efficacy score(Day 43 of treatment (+/- 1 week))
- Total outcome expectations score(Day 43 of treatment (+/- 1 week))
- Total self-care score(Day 85 of treatment (+/- 1 week))
研究者
Annemarie Coolbrandt
Clinical Nurse Specialist oncology
Universitaire Ziekenhuizen KU Leuven