Impact of Training in the Patient-centered Approach on Shared Decision-making in the Colorectal Cancer Screening: a Cluster Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- The Measurement of the achievement oh the shared decision shared decision making in CRC screening using the patient shared a self-decision-making questionnaire (SDM-Q9), validated in French
研究概览
简要总结
The purpose of this study is to compare the effect of face-to-face training of general practitioners on the implementation of a shared decision (in the context of colorectal cancer screening), versus current practice (i.e. without training in the patient-centered approach).
详细描述
Colorectal cancer (CRC) affects 95% of cases of people aged over 50 years old with an average age of diagnosis of 71 years for men and 73 years for women with a higher prevalence in women. By the age of 75, 4 out of 100 men and 3 out of 100 women will have developed colorectal cancer.
In France, CRC screening is based on a guaiac faecal occult blood test in subjects at risk average, carried out every 2 years from 50 to 74 years old. In the event of a positive test, a colonoscopy should be performed. Participation in the programme colorectal cancer screening has been declining since 2016-2017.
The implementation of screening faces many barriers on the physian's side and/or on the patient's side. During of the last 2020-2021 screening campaign, only 6.1 million people took a screening test, which represented a participation rate of 28.9%, while it is commonly admitted that a screening rate >50% would be necessary to reduce CRC mortality.
Some barriers are specific to CRC screening. for patient, reluctance to carry out screening, analysis of stools, and fear of cancer. For the physian, the discomfort in approaching screening and the uncertainty of the relevance of the test for some patients. The know-how and quality of information and communication with patients is at the forefront.
Physian must adapt their communication to the possibilities understanding of the subject to explain, convince, and bring the patient to carry out screening. Active listening is a technique particularly suitable for adopting a person-centred approach making it possible to take into account the patient perspectives in order to arrive at a shared decision.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
盲法说明
Patient not informed of the randomization arm to which their general practitioner enrolled
入排标准
- 年龄范围
- 50 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient aged 50 to 74:
- •Eligible for organized CRC screening,
- •Having declared as attending clinician a general practitioner investigator of the study
- •✓ Consulting their attending clinician for the duration of the study,
- •AND able and willing to comply with all trial requirements
- •Non inclusion Criteria:
- •- ✓ Screened for CRC less than 2 years ago
- •Not eligible for organized CRC screening:
- •History of adenomas or CRC:
- •- Family (1st degree)
- •Personal history of IBD:
- •Crohn's disease
- •Ulcerative colitis)
- •Hereditary predispositions:
- •Familial adenomatous polyposis
- •Hereditary non-polyposis colorectal cancer (Lynch syndrome)
- •Patient with symptoms requiring colonoscopy
- •Having a level of literacy that does not allow the completion of the self-questionnaire.
- •Having an inability to give express consent.
- •Being under guardianship, curatorship or having cognitive disorders
排除标准
- 未提供
研究组 & 干预措施
Interventional arm
The recruited GPs will be randomized into 2 parallel groups (interventional and control). Following this randomization, the GPs from the interventional group will undergo face-to-face training to the patient-centered approach.
干预措施: patient-centered approach training (Procedure)
Control arm
The GPs of the control group will take care the patient according to current screening recommendations and procedures organized by the colorectal cancer (CCR) mass screening.
结局指标
主要结局
The Measurement of the achievement oh the shared decision shared decision making in CRC screening using the patient shared a self-decision-making questionnaire (SDM-Q9), validated in French
时间窗: 6 to 8 months after after patient nclusion (carrying out the screening test)
comparison of the mean of the SDM-Q9 between each arm of the study from 0 (weak shared decision) to 100 (strong shared decision). We will compare the average of the SDM-Q9 between each arm of the study
次要结局
- Confronting the shared decision made by the patient regarding the completion of CRC screening(Measurements taken 6 months after the last patient was included in the trial, i.e. no later than 18 months after the start of the trial)
- Evaluate the effect of training on the CRC screening rate(Measurements taken 6 months after the last patient was included in the trial, i.e. no later than 18 months after the start of the trial)
- Explore understanding of the shared decision process among general practitioners and patients(Data collected immediately after the inclusion visit)