A Phase Two Parallel-group Randomized Controlled Trial Assessing the Efficacy of Open Dialogue About Complementary Alternative Medicine (CAM) Integrated in Conventional Oncology Care
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 112
- 试验地点
- 1
- 主要终点
- Difference in frequency of adverse events grade 3-4 between the two arms
研究概览
简要总结
The purpose of this phase two parallel-group randomized controlled trial is to assess the efficacy of open dialogue about CAM integrated in conventional oncology care. The investigators hypothesize that patients in the intervention group participating in a scheduled open dialogue with a nurse specialist about CAM will experience better physical and mental health compared to patients in the control group receiving standard care alone.
详细描述
Patients randomized to the intervention group will participate in a scheduled open dialogue about CAM with a specialist nurse, who has completed the Fellowship in Integrative Medicine at the University of Arizona. This is a training program for health professionals in empowering individuals and communities to optimize health and well-being through evidence-based, sustainable and integrative approaches. The open dialogue will be based on the fundamentals of person-centered care according to this program and include patient preferences and wishes, reliable information and counselling and advice about the potential risks and benefits of using CAM as an adjunct to conventional oncology care.
All dialogue, each lasting approximately 60 minutes, will be conducted by the same nurse as soon as possible and at the latest two weeks after enrolment. According to patient needs and wishes there may be a follow-up dialogue over the telephone or in the Oncology Outpatient Clinic. The potential second dialogue is estimated to last approximately 30 minutes.
Participants in the control group will receive standard information including reference to www.KABcancer.dk, which is a website presenting research on CAM, including information about its potential effects and outcomes.
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
- •Age 18 or more
- •Speaks and reads Danish
- •Diagnosed with a new primary cancer or a relapse of cancer within the last 3 months
- •Planned or initiated medical oncology treatment at the Department of Oncology, Vejle Hospital
- •At least two months of oncology treatment is realistic based on clinical assessment
- •Life expectancy of at least six months
- •Informed consent
排除标准
- •Participation in other trials
研究组 & 干预措施
Open dialogue about CAM
Participation in an open dialogue about CAM with a nurse specialist. The dialogue will be based on the fundamentals of person-centered care and include patient preferences and wishes, reliable information and counselling, and advice about the potential risks and benefits of using CAM.
The dialogue is estimated to last approximately 60 minutes and all dialogues will be conducted by the same nurse. Depending on patient needs and wishes there may be a follow-up consultation one month after the first dialogue.
干预措施: Open dialogue about complementary alternative medicine (Other)
Standard care
Standard care including referral to a homepage about complementary alternative medicine
干预措施: Standard care (Other)
结局指标
主要结局
Difference in frequency of adverse events grade 3-4 between the two arms
时间窗: 8 weeks after enrolment
Adverse events are graded according to the Common Terminology Criteria for Adverse Events (CTCAEv5)
次要结局
- Difference in patient reported degree of anxiety and depression between the two arms(At baseline and after 12 and 24 weeks)
- Difference in frequency of adverse events grade 3-4 between the two arms(At baseline and after 12 and 24 weeks)
- Difference in patient reported quality of life between the two arms(At baseline and after 12 and 24 weeks)
- Difference in patients' evaluation of received information between the two arms(At baseline and after 12 and 24 weeks)