Implementation of the Symptom Navi© Program for Cancer Patients in Ambulatory Services: A Cluster-randomized Pilot Study (Symptom Navi© Pilot Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 134
- 试验地点
- 9
- 主要终点
- Change in patient-reported symptom interference with daily function
研究概览
简要总结
The Symptom Navi© Program is a program to support symptom self-management of 16 core symptoms frequently experienced by patients in outpatient oncology units.The current study aims to pilot test the implementation of the Symptom Navi© Program under real-life conditions by evaluating procedures, testing preliminary effectiveness and assessing potential unintended effects using a cluster-randomised waitlist design complemented by qualitative methods.
详细描述
Patients treated in cancer outpatient settings in Switzerland have high unmet care needs, especially in the domain of self-management of symptoms. The Symptom Navi© Program was developed to support symptom self-management of 16 core symptoms frequently experienced by patients in outpatient oncology units. The acceptability and feasibility of the Symptom Navi© Program was supported by a qualitative study with 10 cancer patients who received semi-structured patient consultations and subsequently used the Symptom Navi© Flyers at home.
The overall objective of the current study is to pilot test the implementation of the Symptom Navi© Program under real-life conditions. The aims are to evaluate procedures, to test preliminary effectiveness and to assess potential unintended effects using a cluster-randomised waitlist design complemented by qualitative methods. The unit of randomization are the participating cancer outpatient centres with each centre representing a cluster. Intervention cluster will provide the Symptom Navi© Program, control clusters will provide usual care for symptom-management.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •for patients:
- •age ≥ 18 years
- •newly diagnosed with cancer within 15 weeks prior to informed consent signature
- •planned to receive first cycle of their first-line pharmacological anti-cancer treatment in an outpatient centre (intravenous, oral or subcutaneous)
- •signed informed consent
排除标准
- •for patients:
- •not sufficiently literate in German language to understand written information or follow an interview
- •recurrence of cancer disease
- •cared by a palliative care team
- •being treated solely with surgical or radiation therapy
研究组 & 干预措施
Symptom Navi© Program
Nurses provide two semi-structured consultation to facilitate basic symptom self-management of patients based in the Symptom Navi© Flyers
干预措施: Symptom Navi© Program (Behavioral)
Standard care
Standard care including information about treatment, potential side effects and expected symptoms under treatment with or without additional written material following the established procedure at the centre.
结局指标
主要结局
Change in patient-reported symptom interference with daily function
时间窗: Change from baseline to 16 weeks
Symptom interference with daily function in the affective and activity subdimension scores of the MD Anderson Symptom Inventory (MDASI)
次要结局
- Change in patient-reported quality of nursing care(Change from baseline to 16 weeks)
- Change in patient-reported self-efficacy(Change from baseline to 16 weeks)
- Change in patient-reported symptom severity(Change from baseline to 16 weeks)
- Reach of intervention in terms of proportion of eligible vs. participating patients(Up to 16 weeks)
- Incidence of Intervention-Emergent Adverse Events(Up to 16 weeks)
研究者
Manuela Eicher
Prof. Dr.
University of Lausanne