The Involvement of Breast Cancer Patients During Oncological Consultations. A Multi-centre Randomized Controlled Trial. The Study Protocol
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- number of question during the consultation
研究概览
简要总结
The main aim of the study is to assess if a pre consultation intervention facilitates greater participation of patients (and accompanying key persons when present) in the consultation process by determining an increase in questioning and/or in the number of different illness related issues (e.g. diagnosis, treatment, prognosis) being discussed with the oncologist.
Other aims are to assess the effect of the intervention on the oncologist's level of patient involvement, on patient satisfaction and coping and to explore the role of key persons accompanying the patient.
The investigators expect that patients who have the opportunity to rehearse their informative needs before the consultation will ask a greater number of questions which in turn will determine their greater involvement by the physician and a greater number of satisfied needs. The investigators expect also that the straightforward use of a list of printed questions of potential relevance for cancer patients and their companions at an early stage of illness, by modifying the process of information exchange, increases their participation and satisfaction with the consultation, with potential benefits for treatment adherence and consequently treatment efficacy.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •all consecutive patients
- •age between 18 and 75 years
- •attending the Oncology Out-patient Clinics of the participating centres
- •recent diagnosis of breast cancer at an early stage
排除标准
- •presence of metastasis or relapse
- •severe mental deterioration
- •comprehension difficulties of the Italian language.
结局指标
主要结局
number of question during the consultation
时间窗: 1 hour after the intervention (question prompt-sheet)
The intervention prompt-sheet aims to increase the number of question by giving the opportunity to patients and companions to reflect on their informative needs on the basis of a wide range of possible questions from which to choose those perceived as most relevant in view of the subsequent consultation. Question asking is considered an index for patient participation during the consultation. The total number of patient questions during the consultation regarding diagnosis, prognosis, treatment and other issues is the primary outcome measure.
次要结局
- The number of informative needs not met during the consultation.(1 hour after the intervention (question prompt-sheet))
- Ability to cope with the illness(2 hours after the intervention (question prompt-sheet))
- Patient involvement (SDM-Q and OPTION)(2 hours after the intervention (question prompt-sheet))
- Satisfaction with decisions (SWD).(2 hours after the intervention (question prompt-sheet))
- Recalling and understanding of information(2 hours after the intervention (question prompt-sheet))
- Overall consultation atmosphere (VR-COPE, RIAS, AIMIT on the audio-recorded consultation)(1 hour after the intervention (question prompt-sheet))
- Perceived Patient-doctor relationship (PDRQ-9 and DDPRQ-10)(2 hours after the intervention (question prompt-sheet))
- Perceived role preference of the patient (CPS)(2 hours after the intervention (question prompt-sheet))