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
研究组 & 干预措施
Comparison group
The comparison group will receive standard care.
Intervention group
After completion of the comparison group, new patients starting chemotherapy treatment will be offered this study. Study participants will receive the nurse support and selfmanagement intervention.
干预措施: Nurse support and selfmanagement intervention (Behavioral)
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