The Efficacy of Open Dialogue About Complementary Alternative Medicine Integrated in Conventional Oncology Care. Patient Reported Quality of Life and Well-being (CAMONCO 2)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 210
- 试验地点
- 2
- 主要终点
- Difference in patient reported quality of life between the two arms at 8 weeks as measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ CAT core)
研究概览
简要总结
The purpose of this phase III parallel-group randomized controlled trial is to assess the efficacy of open dialogue about complementary alternative medicine integrated in conventional oncology care (ODC-COC). The investigators hypothesize that patients in the intervention group participating in an ODC-COC with a nurse specialist report better quality of life 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 ODC-COC 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 ODC-COC 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 complementary alternative medicine as an adjunct to conventional oncology care.
The dialogue lasts approximately 60 minutes and will take place as soon as possible and no later than two weeks after enrolment. The same nurse will conduct all dialogues. 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
- •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
结局指标
主要结局
Difference in patient reported quality of life between the two arms at 8 weeks as measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ CAT core)
时间窗: 8 weeks after enrollment
This instrument lists individually tailored questions assessing quality of life, including functional scales, symptom scales, global health status, and psychosocial scales.
次要结局
- Difference in overall survival between the two arms(12 months after enrollment of last patient)
- Difference in patient reported quality of life between the two arms at 12 and 24 weeks as measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ CAT Core).(At baseline and after 12 and 24 weeks)
- Difference in patient reported top concerns in the two arms as measured by the Measure Yourself Concerns and Wellbeing (MYCaW) questionnaire.(At baseline and 8, 12 and 24 weeks after enrollment)
- Difference in patient reported level of depression and anxiety between the two arms as measured by the Hospital Anxiety and Depression Scale (HADS).(At baseline and 8, 12 and 24 weeks after enrollment)
- Difference in patient reported decision regret in the two arms as measured by the Decision Regret Scale (DRS).(At baseline and 8 weeks after enrollment)