Evaluating a Decision Aid in Clinical Practice for Patients With T3/T4 Laryngeal Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 9
- 试验地点
- 2
- 主要终点
- Decisional conflict (patients, evaluation phase)
研究概览
简要总结
Patients diagnosed with T3/T4 laryngeal cancer in general have several treatment options available, including total laryngectomy and/or (chemo-) radition. In order to help these patients in the decision making process, MAASTRO CLINIC designed and developed a web-based decision aid tool (Treatmentchoice). The aim of this study is twofold: user-testing Treatmentchoice using a systematically development process and establish the impact of Treatmentchoice on the decision making process.
The study covers 4 chronological activities: 1. assess decisional needs of patients and clinicians, 2. testing patients' and clinicians comprehensibility, acceptability and usability on the alpha-version of the tool, 3. establish the impact of Treatmentchoice on knowledge, decisional conflict and the shared decision making process, as well as the extent clinicians involve patients in decision making and 4. development of an implementation and dissemination plan for shared decision making which is based on the evaluation of barriers and facilitators for the use of patients decision aid tools in clinical practice.
A mixed method will be used. It comprises structured interviews combined with think aloud and questionnaires with stakeholders involved in the whole process (patients, medical doctors, nurses, general practitioners, patient organizations, and insurance companies).
详细描述
Laryngeal cancer is the second most common head and neck cancer. Each year about 700 people are diagnosed with larynxcarcinoma in the Netherlands (Van Dijk et.al. 2013).
For patients with laryngeal cancer, various treatment options are available, including surgery, radiotherapy, chemotherapy and endoscopic (laser) treatment. Each option has its own benefits and side effects. The optimal treatment for patients having stage 3 or 4 laryngeal cancer is not unambiguously proven. Different treatment options cause different side effects that may impact the patients' health-related quality of life. The treatment of choice depends on preferences and personal values. In these preference-sensitive choices it is important to involve the patient in the decision-making process. In this process both the practitioner and the patient exchange information and collaborate in the decision, the physician knows more technical information about the disease, the treatment options and the side effects, the patient knows how the treatment options correspond with his lifestyle, values and preferences (Frosch DL and Kaplan RM, 1999; O'Connor AM, et.al. 2003; O'Connor AM, et.al., 2004).
Patient Decision Aids (PDAs) are tools that can help patients to get involved in decision making by clarifying treatment options, outcomes, and personal values. In the development process of a decision aid it is mandatory to follow a systematic and iterative approach to: (a) understand patient's decisional needs; (b) create prototypical tools; (c) evaluate these prototypes with patients and clinicians, and (d) use these results to improve the tool.
Considering the International Patient Decision Aid Standards (http://ipdas.ohri.ca/), we designed an initial prototype, called Treatmentchoice (http://www.treatmentchoice.info). These standards recommend assessing patients and doctors views in decisional needs, use this information to develop an alpha version of the PDA and validate it again with patients and doctors to create a beta version.
The aim of this project is user-testing the initial prototype of the Treatmentchoice. This will allow us to follow a systematically development process and to gain knowledge on the validity of our approach. The project covers 4 chronological activities:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- 是
入选标准
- •Larynx cancer patients
- •Inclusion Criteria:
- •Larynx cancer: T3 anyN M0, T4 anyN M0
- •Proficient in Dutch
- •minimal 18 years old
排除标准
- •Patients that do not have a treatment choice (due to contra-indications or other medical reasons)
- •patients with recurrent disease
- •For alpha testing patients that already made there decision are selected. For each treatment option (external beam RT, surgery and chemoradiation) at least 10 patients will be included. For beta testing patients that are facing their decision will be included. Aiming for an effect size of 0.60 for a difference in mean total score on the Decisional Conflict Scale, it would require 45 patients per hospital (pre and post intervention) to determine this effect with alpha 0.05 and power 0.
- •Radiotherapy-oncologists
- •Oncologists
- •General practitioners
- •Nurses For alpha testing at least 10 physicians are selected. For beta testing at least 45 questionnaires are required.
- •Patient organizations and insurance companies Besides patients and physicians, patient organizations and insurance companies will be involved to evaluate barriers and facilitators for implementation in clinical practice.
结局指标
主要结局
Decisional conflict (patients, evaluation phase)
时间窗: 2 weeks after diagnosis
Decisional conflict will be assessed using the DCS (Decisional conflict scale): change in DCS between baseline group (usual care) and intervention group (use of the aid tool)
Patient's decisional needs to make a decision about their treatment
时间窗: up to 1 year
Patients' decisional needs (development phase):semi-structured interviews with patients about their medical history, their experience with the treatment, the decision about their treatment, and what information the patients need to make
Comprehensibility of the decision aid too
时间窗: up to 1 year
Quantitative research using the Unified Theory of Acceptance and Use of Technology (UTAUT Venkatesh et al. 2013). This questionnaire. (5-Likert) measure how patients and clinicians perceived its utility, effectiveness and efficiency for shared decision-making, as well as their satisfaction with the decision aid.
Usability of the decision aid too
时间窗: up to 1 year
Quantitative research using a questionnaire based on the International Standard ISO-9242-11. This questionnaire (5-Likert) measure to what extent the decision aid is easy to use.
Control Preference Scale (patients; evaluation phase)
时间窗: 2 weeks after diagnosis
Patient's preference to participate in medical decisions will be assessed using the 5-item Control Preference Scale (CPS):change in CPS between baseline group (usual care) and intervention group (use of the aid tool)
Perception shared decision-making (patients; evaluation phase)
时间窗: 2 weeks after diagnosis
Patient's perception of the shared decision-making process will be assessed using the (shared decision making) SDM-Q9 instrument for patients: change in SDM between baseline group (usual care) and the intervention group (use of the aid tool)
. Perception shared decision-making (doctors; evaluation phase)
时间窗: 2 weeks after diagnosis
Doctor's perception of the shared decision-making process will be assessed using the SDM-Q9 instrument for professionals: change in SDM between baseline group (usual care) and the intervention group (use of the aid tool)\]\]
次要结局
- Patients' satisfaction with decision aid (Treatmentchoice)(upto 1 year)
- Patients' views on the current decision-making process(upto 1 year)
- Patients' intention to use and recommend Treatmentchoice to others(an average of 2 year)
- Insights into the value clarification process of prostate cancer patients(an average of 2 year)