Shared Decision Making on Care Pathways and CAMs: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Feasibility of a study proposing a therapeutic education consultation linked to the usual course of care
研究概览
简要总结
Shared Decision Making on Care Pathways and alternative and complementary medicine (CAMs) : A Pilot Study.
Study whose aim is to evaluate the feasibility of a study proposing a therapeutic education consultation leaning on the usual care pathway by estimating the recruitment capacity over 4 months as well as the acceptance rate of the study among patients diagnosed with breast cancer.
详细描述
The use of alternative and complementary medicine (CAMs) has been steadily increasing for several years. Certain populations are more likely than others to use this type of care, including breast cancer patients, for whom the rate of use is close to 90%. However, these populations are those for whom the risks associated with this type of care are the highest. In addition, patients rarely discuss alternative and complementary medicine (CAMs) with conventional care teams. As a result, patients often place unreasonable expectations on alternative and complementary medicine (CAMs) and at the same time put themselves in risky situations.
The aim of this project is to help breast cancer patients better orient themselves in their care pathway and in particular with regard to the plethora of alternative and complementary medicine (CAMs) available. They could therefore make an informed decision to seek (or not) treatment. In order to reach a shared decision, a consultation will be offered to patients with the objective of discussing their past recourse, their knowledge of the care pathway, their fears and their aspirations with regard to alternative and complementary medicine (CAM). Epistemological concepts (self-efficacy, placebo, benefit-risk ratio, etc.) will be discussed in order to allow these elements to be transposed throughout their care.
The impact of this consultation on compliance with conventional treatment, satisfaction with the treatment as a whole and communication with the rest of the health care team will be evaluated. A before/after methodology will first allow us to evaluate the values taken by our judgement criteria in the usual care pathway and then in the innovative care pathway proposed by the intervention. This study will allow us to establish the feasibility of a future research project of larger scale.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Patients recently diagnosed with breast cancer at Grenoble Alpes University Hospital
- •In situ or invasive breast cancer, locally advanced but without metastasis, demonstrated on histology
- •ECOG ( Eastern Cooperative Oncology Group) performance status 0, 1 or 2
- •Cancer treated with chemotherapy, radiotherapy and/or surgery
- •Having signed an informed consent after information, being of age and able to express consent, affiliated to a social security system
排除标准
- •Pregnant, breastfeeding or parturient women
- •women who do not speak French;
- •patients participating in another research protocol
- •Metastatic breast cancer, diagnosed psychiatric pathologies that make it impossible to perform the procedure, history of cancer except for cervical cancer in situ or basal cell cancer
- •Subjects in a period of exclusion from another study,
- •Subject under administrative or judicial supervision
- •Subject unable to be contacted in case of emergency
研究组 & 干预措施
Before group
Patients in the before group are recruited during the first 4 months of the study and will not benefit from the alternative medicine education consultation
After Group
Patients in the front group are recruited from the 5th month of the study and will benefit from the alternative medicine education consultation
干预措施: alternative medicine education consultation (Other)
结局指标
主要结局
Feasibility of a study proposing a therapeutic education consultation linked to the usual course of care
时间窗: 8 month
The investigators wish know the recruitment capacity in this study. To do this, the investigators will estimate the number of people included over 8 months (time of recruitment in the study).
次要结局
- Success in orienting to the care pathway(inclusion, 6 month)
- Assess satisfaction with the current care pathway(6 month)
- Evaluate literacy in the care pathway.(inclusion, 6 month)
- To assess patient adherence, patient believes in the mechanics of TACs operation.(inclusion, 6 month)
- Satisfaction with improvement in orientation to the care pathway(6 month)
- Collect the patient experience(6 month)
- Assess patient satisfaction with the procedure.(After intervention, 6 month)
- To assess co-variance between oncologist and patient beliefs in TACs operating mechanisms(Inclusion)
- To assess the use of TACs(inclusion, 6 month)
- To assess satisfaction with TACs(inclusion, 6 month)
- To assess satisfaction with oncology care.(6 month)
- Assess patient recommendation of the intervention(After intervention, 6 month)